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Pharmaceutical Microbiology UK
20 January - 21 January 2020
Pharmaceutical Microbiology UK

SAE Media Group’s 9th Annual Conference
Pharmaceutical Microbiology UK
January 20 - 21, 2020 | London, United Kingdom
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Pharmaceutical Microbiology as an industry is projected to see significant advancements in the next five years. This forecast is largely attributed to rapid microbiology testing, which has accounted for $3.5 billion last year, while projected to reach nearly double at $6 billion by 2025, and an estimated CAGR of 8.3% leading up to 2025.


At the very core of pharmaceutical microbiology is the accurate and reliable detection of microorganisms that would otherwise contaminate the pharmaceutical products manufactured. This demand for more rapid methods for detection and identification will be accompanied by equally important areas such as: contamination control strategies and environmental monitoring, process automation, and discussing updates to meet regulatory requirements.
 

Join us this year to explore novel and developing technologies that tackle the most pressing challenges and push innovation in world of pharmaceutical microbiology.
 

FEATURED SPEAKERS

David Elder

David Elder

Constultant, David P Elder Consultancy
Di Morris

Di Morris

Audit Manager CAGá, Gsk
Gabriele Savoldi

Gabriele Savoldi

Business Development Manager, Copan Group
Henrietta Vinneras

Henrietta Vinneras

Senior Manager, Microbiology & Aseptic Technique, Fresenius Kabi
Ian Symonds

Ian Symonds

Director, Pharmaceutical Consultant, SDA Pharma
Ingo Spreitzer

Ingo Spreitzer

Deputy head Section Microbial safety, Paul Ehrlich Institut
James Cannon

James Cannon

Head of OEM and Markets, Mettler-Toledo Thornton
James Drinkwater

James Drinkwater

Chairman of PHSS and Head of GMP Compliance F Ziel GmbH, PHSS
Jason  McGuire

Jason McGuire

Vice President, Global Quality, Fagron
Jim Polarine

Jim Polarine

Technical Service Manager, Steris Corp
Lin Tan

Lin Tan

CCIT Scientist, AstraZeneca
Maria Jose Zafra-Domene

Maria Jose Zafra-Domene

QC Microbiologist, MeiraGTx
Mitesh Patel

Mitesh Patel

Principal Microbiologist, GSK
Olivier Chancel

Olivier Chancel

Sterility Assurance Expert, Boehringer Ingelheim
Renate Rosengarten

Renate Rosengarten

Professor and Chair of Bacteriology and Hygiene, University of Veterinary Medicine Vienna/Mycosafe Consulting
Shabnam Solati

Shabnam Solati

CEO & Co-Founder, CTL-MAT
Sonia  Allibardi

Sonia Allibardi

Market Access Manager, Copan Group
Sophie Drinkwater

Sophie Drinkwater

QC Technical Officer, AstraZeneca
Sylvanie Cassard Guilloux

Sylvanie Cassard Guilloux

Global solution Manager, BioMérieux
Tim Eaton

Tim Eaton

Sterile Manufacturing Specialist, AstraZeneca
Veronika Wills

Veronika Wills

Manager, Technical Services, Associates of Cape Cod

David Elder

Constultant, David P Elder Consultancy
David Elder

Dr. Elder has 42 years of service within the pharmaceutical industry, with Sterling, Syntex and 23 years with GSK. He is now an independent CMC consultant and has broad based experience in formulation, microbiology and analytical method development.
Dr. Elder obtained his PhD in crystallography from the University of Edinburgh. Dr. Elder is a visiting professor at King’s College, London. He is a Fellow of the RSC and chartered chemist and scientist. He is a member of the British Pharmacopoeia. He is the chairman of JPAG (Joint Pharmaceutical Analysis Group). He is a member of the Editorial Advisory Board for the Journal of Pharmaceutical Sciences. He has published 18 book chapters, 147 papers in international journals and has given 19 webinars and over 167 presentations at national/international symposia. He has 9 patents to his name.
He has co-edited a book on the Analytical Characterisation and Separation of Oligonucleotides and their Impurities (with George Okafo and Mike Webb) and a second on the ICH Quality Guidelines (with Andy Teasdale and Ray Nims).
 

Di Morris

Audit Manager CAGá, Gsk
Di Morris

Di Morris - MRSC Chemistry and PGDiPS and a Qualified Person under permanent provisions since 1993; Pharmaceutical industry for over 30 years/ a number of years as a Medicines Inspector for the MHRA. Di/worked in the areas of Quality Control (Chemistry and Microbiology), Quality Assurance and Regulatory Affairs/worked with a wide range of dosage forms including sterile products, biological, and non-sterile products.

Gabriele Savoldi

Business Development Manager, Copan Group
Gabriele Savoldi

Mechanical engineer with master’s degree in Biomechanical engineering. In Copan since 2013, currently in charge of the business development of Copan’s automations in the industry field, notably in the food, cosmetics and pharmaceutical sectors.

Henrietta Vinneras

Senior Manager, Microbiology & Aseptic Technique, Fresenius Kabi
Henrietta Vinneras

Mrs Vinnerås has been in the industry since year 2000 and has worked for pharmaceutical and medical device companies such as Pfizer, Abbott, GE Healthcare, Thermo Fisher Scientific and currently at Fresenius Kabi. Mrs Vinnerås is part of a global competence center supporting mainly the companys’ pharmaceutical manufacturing, medical devices and compounding centers world-wide with e.g. establishing global corporate procedures, on-site assessments, education and training, trouble shooting, root cause investigations, CAPAs and continuous improvement projects; specifically within the areas of microbiology and aseptic technique. She is also a member of the PDA Journal of Pharmaceutical Sciences and Technology editorial board.

Ian Symonds

Director, Pharmaceutical Consultant, SDA Pharma
Ian Symonds

Recently established SDA Pharma Limited with co-managing Director Mike Davies. With almost 80 years’ experience in the industry SDA can provide a wide range of services form facility design and Qualification support to bespoke training and regulatory compliance advice.

My role in GSKs Global Quality was responsible for setting and monitoring Quality standards for the Global Manufacture and Supply division for pharmaceutical sterile manufacturing operations worldwide. Following the merger of GlaxoWellcome and SmithKlineBeecham in 2000 I established a team of subject matter experts to establish a common set of compliance standards for the new GSKs Quality Management System. I continued to lead that team right up to my retirement in 2018.

 

Ingo Spreitzer

Deputy head Section Microbial safety, Paul Ehrlich Institut
Ingo Spreitzer

My former research topics (Lectins) and immune-activating components of bacteria introduced me to preparation /purification and bioassays, which until today influences my work on immune-activating / pyrogenic substances. I started at the PEI 2001 with the development and validation of the Monocyte activation test (MAT).
My current duties as deputy at the PEI are drug QC by LAL (all methods) and Pyrogen testing (former rabbit pyrogen test, now replaced by MAT) and scientifically the exploration of the MAT. Our actual interests are drugs with intrinsic pyrogenicity, Outer membrane vesicles, synergistic effects and low Endotoxin recovery (LER).

 

James Cannon

Head of OEM and Markets, Mettler-Toledo Thornton
James Cannon

James B. Cannon is Head of OEM and Markets at Mettler-Toledo Thornton. He has a BSc in Biology, degrees in Microbiology and Biophysics and an MBA in Marketing and International Management.

Mr. Cannon has over 35 years of experience in the management, design and development of ultrapure water treatment and technology. This includes measuring differential conductivity and UV oxidation for the detection of TOC in UPW and the design and commercialisation of electrodeionisation modules.

Mr. Cannon is currently involved in the standards and regulatory organisations for the Semiconductor, Photovoltaic and Pharmaceutical markets, and the commercialisation of alternative microbial technology.
 

James Drinkwater

Chairman of PHSS and Head of GMP Compliance F Ziel GmbH, PHSS
James Drinkwater

James Drinkwater is Head of Aseptic processing technologies & GMP compliance for F Ziel Germany, supporting international projects from a base in the UK. As a subject matter expert in Barrier separation technology; Isolator / RABS and hydrogen peroxide vapour bio-decontamination, James is involved in applications of sterile pharmaceutical product Filling, Aseptic processing of APIs/ ATMPs and Sterility testing.
In addition to the role at F Ziel James has a voluntary role as Chairman of the not for profit society: PHSS – Pharmaceutical and Healthcare sciences society and leads the PHSS Aseptic processing & Bio-contamination special interest group.
 

Jason McGuire

Vice President, Global Quality, Fagron
Jason  McGuire

Jason has spent nearly 20 years in the health care industry serving in many roles with a particular focus on Quality control operations, Quality assurance and regulatory support. He’s a microbiologist by education and expertise, spending 2 years on the bench developing anaerobic microbial catalysts for fuel ethanol production. For the last 15 years, he has worked with non-sterile and sterile compounding facilities, national health systems, medical device, biotechnology and pharmaceutical companies helping them troubleshoot and bringing resolution to complex challenges.

Jim Polarine

Technical Service Manager, Steris Corp
Jim Polarine

Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for eighteen years. His current technical focus is microbial control in cleanrooms and other critical environments. Mr. Polarine is a 2019 PDA Michael S. Korczynski Award recipient. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection and microbial control in cleanrooms. Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He is active as co-chair on the PDA’s microbial investigations task force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. Mr. Polarine teaches the cleaning and disinfection course at the PDA Aseptic Processing Course and at the University of Tennessee’s Parenteral Medications Course. Mr. Polarine is currently President Elect for the PDA Missouri Valley and Technical Coordinator for the IEST. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology. He previously worked as a clinical research coordinator with the Department of Veterans Affairs in St. Louis, MO and as a biology and microbiology instructor at the University of Illinois. His main hobby is storm chasing and is very active in tornado research and tornado safety.

Lin Tan

CCIT Scientist, AstraZeneca
Lin Tan

Lin’s current position is CCIT scientist functioning under Device Functionality, Safety, and Digital Connectivity team within AstraZeneca’s Dosage Form Design and Development Group. Lin is responsible for the development, qualification and transferring of container closure integrity test (CCIT) methods to support all programs across sites, providing SME level technical supports among project teams, resolving CCIT challenges during product life cycle, and supporting commercial operations. In addition, Lin is responsible for developing novel CCIT approaches for atypical container closure systems. Prior to AstraZeneca, Lin worked as CCIT scientist at both GlaxoSmithKline and Whitehouse Analytical Laboratories supporting multiple biopharmaceutical programs. Lin has a B.S. in Biological Science from Shenzhen University and M.S. in Pharmaceutical Manufacturing from Stevens Institute of Technology.

Maria Jose Zafra-Domene

QC Microbiologist, MeiraGTx
Maria Jose Zafra-Domene

Originally from Spain, Maria relocated to the UK after completing her MSc in Biotechnology at the University of Granada. Maria began working as a QC Microbiology Technician in environmental monitoring at Nice Pak International in Flint (Wales), a wet wipes non-cleanroom manufacturing site. From here, Maria established her cleanroom environmental monitoring knowledge at Fresenius Kabi in Runcorn (England). After 6 years, she took on the position of QC Microbiologist in MeiraGTx, a gene therapy start-up based in London. Drawing from her experience, Maria has developed the environmental monitoring programme of a brand-new cleanroom facility within MeiraGTx. Now, she leads a team of QC Microbiology Technicians.

Mitesh Patel

Principal Microbiologist, GSK
Mitesh Patel

Dr Mitesh Patel has over 16 years industrial experience where he has built his microbiological expertise in veterinary, nutritional and most recently consumer health (CH) R&D. Mitesh graduated with a BSc in Biological Sciences an MSc from the University of Nottingham in Medical Molecular Microbiology and a PhD in Epidemiological Microbiology from the University of Birmingham. Within CH R&D he has led microbiology innovations and simplifications in product risk management adopting a Quality by Design (QbD) model to deliver market complaint and microbiologically robust products to consumers on time, every time.

 

Olivier Chancel

Sterility Assurance Expert, Boehringer Ingelheim
Olivier Chancel

Doctor Pharmacist, graduated in technological pharmacy, quality control and management. Currently Sterility and Aseptic Practice Assurance Expert and Senior Quality Auditor. Used to work in or with the pharmaceutical industry for 20 years at various positions including pharmaceutical research and development, Quality Assurance, Quality Control, project management and production for both solid and injectable dosage forms.
Published a number of papers in peer-reviewed journals relating to cleanroom activities or aseptic practices, has cowritten several books and also presented/moderated at various industry forums in Europe, Asia and the US (PDA, A3P, SFSTP, SMI, ASPEC, ECA, PHARMIG...)
 

Renate Rosengarten

Professor and Chair of Bacteriology and Hygiene, University of Veterinary Medicine Vienna/Mycosafe Consulting
Renate Rosengarten

Prof Renate Rosengarten’s career originated from her academic research work which is for more than 40 years marked by a continuous interest in the infection biology of mycoplasmas, and their detection, prevention and control. Her passion for mycoplasmas took her to the University of Veterinary Medicine Hannover in Germany, the University of Missouri-Columbia in the US, and the Hadassah Medical School of the Hebrew University in Jerusalem, Israel. Since 1996 she has been Professor and Chair of Bacteriology and Hygiene at the University of Veterinary Medicine Vienna in Austria. Besides her numerous former functions and activities in organizations and committees, such as President of the International Organization for Mycoplasmology (IOM), President of the Austrian Society for Hygiene, Microbiology and Preventive Medicine (ÖGHMP), Scientific Advisory Board Member of the German Robert Koch Institute (RKI) in Berlin, and Working Group Leader of the Mycoplasma Task Force of the Parenteral Drug Association (PDA), Prof Rosengarten has long-standing entrepreneur and business experience in the area of mycoplasma safety testing. In addition to her academic duties as mentor, lecturer, reviewer, scientific advisor, and committee member, Prof Rosengarten serves since 2004 as an independent mycoplasma expert, key opinion leader and consultant for biopharma, biotech and cell therapy companies under her own international brand Mycosafe® and has recently established a consulting and licensing enterprise.

Shabnam Solati

CEO & Co-Founder, CTL-MAT
Shabnam Solati

Shabnam Solati developed a Monocyte Activation Test to meet the end-to-end MAT needs in the industry, with pyrogen detection and quantification levels that are unprecedented. With the expertise of MAT and the knowledge regarding all the test’s potential abilities, Shabnam is dedicated to building the future of MAT beyond where it is today. Therefore, research, development and innovative technologies are continuous focus points at CTL-MAT.

Sonia Allibardi

Market Access Manager, Copan Group
Sonia  Allibardi

Molecular biologist with a specialization degree in Biochemistry Science. Currently working in the Scientific Team of COPAN as Market Access Manager for the implementation of innovative Medical Devices in pre-analytics focusing on Italy, Eastern Europe and Asia Pacific Market. Her professional life started in a research Cardiovascular Physiology laboratory at San Raffaele Scientific Institute, Milan Italy, where She worked for more than 10 years and published scientific papers on International Journals. The objective of her research was the evaluation of myocardial metabolism in hypoxic and ischemic heart. In 2011, thanks to the “Mad Cow Disease”, She started a new job in Biorad Company. She spent three years as scientific product specialist in the life science division for Italy and Southern Europe (Spain, Greece, Portugal). She moved to Cepheid Europe for five years where her main topics were: Women’s Health, Hospital Acquired Infection and Tuberculosis.

Sophie Drinkwater

QC Technical Officer, AstraZeneca
Sophie Drinkwater

I’m a microbiologist at AstraZeneca, where I have worked for almost 5 years; I’ve spent most of that time in the QC Microbiology labs, but recently I had the opportunity to spend 18 months in Pharmaceutical Technology & Development; this has led to collaborative studies in supporting the microbial control strategy of our oral solid dosage forms and sterile products. I’ve recently transferred to the role of a Technical Officer, where I will be driving microbiology method development and optimisation, including the implementation of modern microbiology techniques.

Sylvanie Cassard Guilloux

Global solution Manager, BioMérieux
Sylvanie Cassard Guilloux

Sylvanie has a strong scientific background (PhD at Paris VII University; post-doctoral experience at Rockefeller University) in cellular and molecular biology. On her return to France, Sylvanie joined industry, and had 13 years of experience as technical leader or in R&D in several laboratories, developing and using molecular methods for industry quality controls, while she also participated to standardization of these methods as a group leader at the french normalization body (AFNOR). In 2012, after a Master of Business at Audencia business school, she joined the global marketing department of bioMérieux, where she is defining and guiding the development of new solutions for pharmaceutical microbiological controls.

Tim Eaton

Sterile Manufacturing Specialist, AstraZeneca
Tim Eaton

Tim Eaton B.Sc. (chemistry) has over 25 years’ experience of steriles manufacture with Zeneca Pharmaceuticals and AstraZeneca. During this time he has had extensive roles in technical support, production management and specialist activities for aseptically prepared products. He has had responsibilities for the design, construction, start up and validation of multimillion pound aseptic manufacturing facilities and has managed the introduction, technical transfer and scale up activities for a number of sterile products. He has published a number of papers relating to cleanroom activities and has also presented at various industry forums in Europe, Asia and the US.
In his current role of Sterile Manufacturing Specialist he has responsibilities for the derivation, optimisation and implementation of best practices for aseptically prepared products. He sits on LBI/30, the British Committee for Cleanroom Technology.
 

Veronika Wills

Manager, Technical Services, Associates of Cape Cod
Veronika Wills

Veronika Wills manages the Technical Services group at Associates of Cape Cod, Inc. She joined the team in 2007 and thanks to her strong knowledge of biochemistry, microbiology and immunology, brings an expertise that is vital to ACC customers when it comes to technical support of testing complex samples, Low endotoxin recovery matrixes and troubleshooting of the Bacterial Endotoxins Test at all levels. Veronika speaks frequently at scientific conferences and seminars globally and is an established expert on endotoxin testing. Veronika holds a Master’s Degree in Biochemical Engineering from the Institute of Chemical Technology in Prague, Czech Republic.

sponsors

Conference agenda

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8:30

Registration & Coffee

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8:50

Workshop Leader's Opening Remarks

James N. Polarine Jr

James N. Polarine Jr, Senior Technical Service Manager, Steris Corporation

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9:00

A Risk-Based Cleaning and Disinfection Program

James N. Polarine Jr

James N. Polarine Jr, Senior Technical Service Manager, Steris Corporation

• Cleaning and Disinfection Methods and Frequencies
• Disinfectant Rotation
• Rinsing and Residue Removal Frequencies
 

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9:35

Bringing the Cleanroom Online After a Worst-Case Event

James N. Polarine Jr

James N. Polarine Jr, Senior Technical Service Manager, Steris Corporation

• Cleaning Steps Cleanroom Control
• Triple Cleaning Methods and Case Study
• Cleanroom Utilities and Operations Online
 

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10:10

Morning Coffee

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10:30

Disinfection Validation

James N. Polarine Jr

James N. Polarine Jr, Senior Technical Service Manager, Steris Corporation

• Requirements for Manufacturers
• Requirements for Pharmaceutical, Biotech, and Medical Device Industries
• Case Studies in Disinfectant Validation
 

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11:05

Continuation of Disinfectant Validation and Contamination Control Case Studies

James N. Polarine Jr

James N. Polarine Jr, Senior Technical Service Manager, Steris Corporation

• Overview of Disinfectant Validation
• Case Studies in Contamination Control
• Methods to Proactively Prevent Bioburden from Entering Cleanrooms
 

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11:30

Session Recap

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11:40

Networking Lunch

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12:40

Opening remarks and introductions

Ian Symonds

Ian Symonds, Director, Pharmaceutical Consultant, SDA Pharma

Michael Davies

Michael Davies, Director, Independent Pharmaceutical Consultant, SDA Pharma Ltd

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12:50

Designing and Environmental Monitoring Programme: Regulatory History

• A brief introduction to history of the regulations governing the manufacture of sterile parenteral products and providing some examples of regulatory findings with regard to non-compliance.
• Delegates should leave with a clear understanding of the very important but subtle difference between written regulatory guidance and regulatory expectations and the legal framework supporting the regulatory environment.
 

Ian Symonds

Ian Symonds, Director, Pharmaceutical Consultant, SDA Pharma

Michael Davies

Michael Davies, Director, Independent Pharmaceutical Consultant, SDA Pharma Ltd

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13:35

Environmental Monitoring In Context

• This session will focus on the limitations of environmental monitoring and discuss the fundamental aims of using EM to provide a level of assurance that good aseptic control is being maintained. Stress will be placed on the need for good design and operations of a facility to give credence to EM data and decisions that may result from that data interpretation.

Ian Symonds

Ian Symonds, Director, Pharmaceutical Consultant, SDA Pharma

Michael Davies

Michael Davies, Director, Independent Pharmaceutical Consultant, SDA Pharma Ltd

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14:10

Microbiological Monitoring Equipment and Media

This session will focus on the monitoring equipment and media used providing an insight to the techniques used in the monitoring process. The session will include some fundamental microbiology to put the monitoring and media into context. This will merge with session 4 which will be a fully interactive.

Ian Symonds

Ian Symonds, Director, Pharmaceutical Consultant, SDA Pharma

Michael Davies

Michael Davies, Director, Independent Pharmaceutical Consultant, SDA Pharma Ltd

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14:45

Design of An Environmental Monitoring Programme

• This will be a fully interactive session which will involve designing an environmental monitoring programme based on a generic facility design using risk assessment. A range of props will be provided and delegates will be on their feet for most of the time working in small teams.
• This workshop will enable delegates to leave with an understanding of the strengths and limitations of an environmental monitoring programme and how to design one. It will put the data generated into a regulatory compliance context.
 

Ian Symonds

Ian Symonds, Director, Pharmaceutical Consultant, SDA Pharma

Michael Davies

Michael Davies, Director, Independent Pharmaceutical Consultant, SDA Pharma Ltd

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15:30

Afternoon Coffee

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15:55

Rapid Micro Methods, Endotoxin Testing and LER

Felix A. Montero- Julian

Felix A. Montero- Julian, scientific director, BioMerieux Marcy L'Etoile

Stefane Schweicher

Stefane Schweicher, Business Development Manager, Biomerieux

Dina Laoui

Dina Laoui, Business Manager Americas, BioMerieux, Inc.

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16:00

Update on RMM Regulation

Felix A. Montero- Julian

Felix A. Montero- Julian, scientific director, BioMerieux Marcy L'Etoile

Stefane Schweicher

Stefane Schweicher, Business Development Manager, Biomerieux

Dina Laoui

Dina Laoui, Business Manager Americas, BioMerieux, Inc.

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16:35

Evaluating and validating the best RMM Application based on Your Needs

Felix A. Montero- Julian

Felix A. Montero- Julian, scientific director, BioMerieux Marcy L'Etoile

Stefane Schweicher

Stefane Schweicher, Business Development Manager, Biomerieux

Dina Laoui

Dina Laoui, Business Manager Americas, BioMerieux, Inc.

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17:10

Afternoon Tea

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17:30

Endotoxin Detection

Felix A. Montero- Julian

Felix A. Montero- Julian, scientific director, BioMerieux Marcy L'Etoile

Stefane Schweicher

Stefane Schweicher, Business Development Manager, Biomerieux

Dina Laoui

Dina Laoui, Business Manager Americas, BioMerieux, Inc.

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18:05

LER

Felix A. Montero- Julian

Felix A. Montero- Julian, scientific director, BioMerieux Marcy L'Etoile

Stefane Schweicher

Stefane Schweicher, Business Development Manager, Biomerieux

Dina Laoui

Dina Laoui, Business Manager Americas, BioMerieux, Inc.

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18:40

Closing remarks

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8:30

Registration & Coffee

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9:00

Chair's Opening Remarks

Olivier Chancel, Sterility Assurance Expert, Boehringer Ingelheim

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9:10

Regulatory expectations and supportive guidance on Bio-contamination control and monitoring in Aseptic manufacturing of sterile products

James Drinkwater, Chairman of PHSS and Head of GMP Compliance F Ziel GmbH, PHSS

• Regulatory requirements e.g. Annex 1, 2, Regulatory expectations e.g. Q&A, Blogs, supportive GMP Guidance e.g. PHSS, BioPhorum (BPOG) – how they relate and current harmonization initiatives.
• Preparation of a Contamination Control Strategy (CCS) – an Annex 1 requirement and Considerations in preparation of an Aseptic-Containment Strategy (ACS) if toxic or biologically active products are aseptically processed and/or cross contamination control is required.
• Risk based rationale and supporting risk assessments to setting environmental monitoring locations and sampling frequencies – PHSS and BPOG collaboration initiative.
 

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9:50

The Story Behind the Microbiological Data – and the Possible Paths Away from Recurring Events

Henrietta Vinneras, Senior Manager, Microbiology & Aseptic Technique, Fresenius Kabi

• When we are using the CCS our monitoring activities will also result in OOT’s and OOL’s for our environmental monitoring data – and even OOS’s for endotoxins, sterility tests or bioburden – and then what happens?
• How do we approach the event via data, trend evaluation, non-conformance reporting, additional testing/sampling, investigational tools and risk assessments?
• How do we establish proper CAPA’s and effectiveness checks as part of our continuous improvement initiatives to prevent recurrence?
• The talk also builds upon cases from industry to help explain the events
 

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10:30

Morning Coffee

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11:00

Panel Discussion: The Impact of the Annex 1 Revision on Pharmaceutical Microbiology

• Which RMM technologies are being used without regulatory conflict on microbiological sampling results - Is industry ready for integration of digital platforms?
• The removal of contamination risk from operators through use of gloveless cells and robotics in filling platforms
• What does the unity of environmental classification, qualification and process monitoring mean to EM programs and data management of total particulate and microbiological samples?
• How do we manage risks associated with aseptic manufacturing of toxic and biologically hazardous products such as EM sample contamination, product cross contamination and personnel exposure?
• Assessing the disinfection rotation section on the use of multiple disinfectants to prevent the development of resistant strains – is there enough evidence?
• Revisiting the potential latent risk of VBNC and stressed microbial contamination in sterile product manufacturing
 

Olivier Chancel, Sterility Assurance Expert, Boehringer Ingelheim

James Drinkwater, Chairman of PHSS and Head of GMP Compliance F Ziel GmbH, PHSS

• Which RMM technologies are being used without regulatory conflict on microbiological sampling results - Is industry ready for integration of digital platforms?
• The removal of contamination risk from operators through use of gloveless cells and robotics in filling platforms
• What does the unity of environmental classification, qualification and process monitoring mean to EM programs and data management of total particulate and microbiological samples?
• How do we manage risks associated with aseptic manufacturing of toxic and biologically hazardous products such as EM sample contamination, product cross contamination and personnel exposure?
• Assessing the disinfection rotation section on the use of multiple disinfectants to prevent the development of resistant strains – is there enough evidence?
• Revisiting the potential latent risk of VBNC and stressed microbial contamination in sterile product manufacturing
 

Tim Eaton, Sterile Manufacturing Specialist, AstraZeneca

Jim Polarine, Technical Service Manager, Steris Corp

Di Morris

Di Morris, Audit Manager CAGá, Gsk

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12:00

Automation for incubation and colony counting of Environmental Monitoring samples: process optimization and data integrity

Sonia Allibardi, Market Access Manager, Copan Group

Gabriele Savoldi, Business Development Manager, Copan Group

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12:40

Networking Lunch

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13:40

Mycoplasma Safety of ATMPs

Renate Rosengarten, Professor and Chair of Bacteriology and Hygiene, University of Veterinary Medicine Vienna/Mycosafe Consulting

  • Mycoplasmas as contaminants in manufacturing processes of ATMPs
  • Features of mycoplasmas with respect to their contamination potential
  • Uncommon mycoplasma species as contaminants
  • Primary mycoplasma entry points
  • Product-relevant mycoplasma species for ATMPs
  • Risk and suitability assessments as important basis for implementing rapid batch release testing of ATMPs
  • Evaluation of which mycoplasma species are product-relevant and which commercial PCR test system is most suitable to detect them
  • Selection of the right panel of mycoplasma reference standards for product-specific PCR validation


     

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    14:15

    New At-line Automated Mycoplasma Testing: A Performance Evaluation of BioFire Mycoplasma

    Sylvanie Cassard Guilloux, Global solution Manager, BioMérieux

    • Current methods description
    • New technology: how it works? What are the benefits?
    • Internal validation data according to Pharmacopeia guidelines
     

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    14:55

    Effective Risk Management of Microbial Contamination

    Tim Eaton, Sterile Manufacturing Specialist, AstraZeneca

    • Risk assessment methods for microbial contamination
    • Quantification of microbial contamination using environmental monitoring data
    • Meaningful cleanroom environmental monitoring and Annex 1 considerations
    • Effective risk based monitoring locations utilising appropriate risk factors
     

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    15:30

    Afternoon Tea

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    16:00

    Current status of the MAT and rFc

    Ingo Spreitzer, Deputy head Section Microbial safety, Paul Ehrlich Institut

    • Foreseen modification of MAT 2.6.30.
    • Feedback on draft rFc 2.6.32.
    • European and global situation of MAT and rFc
     

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    16:35

    Monocyte Activation Test: The Superior Choice for Testing Medical Products and Protecting Patients from Contamination

    Shabnam Solati, CEO & Co-Founder, CTL-MAT

    • Presenting the MAT as a robust, reproducible, sensitive and human specific pyrogen testing
    • An end-to-end process: MAT kit generation, test performance and product-specific validation
    • Presenting the solution to the recent EP criteria: MAT as risk assessment for the endotoxin test and replacement of RPT
    • The solution for pyrogenicity tests of medical devices
     

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    17:15

    Microbial Control Considerations for Tablet Manufacture

    Sophie Drinkwater, QC Technical Officer, AstraZeneca

    • Overview of microbial control strategy of the manufacture of oral solid dosage forms
    • Summary of three laboratory based challenge studies
     o Growth potential of microorganisms in coating suspensions
     o Behavior of microorganisms in tablet coating processes
     o Survival of microbes in wet granulation processes
    • Application of Water Activity for risk-based testing plans
     

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    17:50

    Chair’s Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

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    9:00

    Chair's Opening Remarks

    James Drinkwater, Chairman of PHSS and Head of GMP Compliance F Ziel GmbH, PHSS

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    9:10

    Common Myths and Urban Legends in the Pharmaceutical Industry Related to Contamination Control

    Jim Polarine, Technical Service Manager, Steris Corp

    • Disinfectant Quantity – The misconception that more disinfecting agent is always better for sanitization of surfaces.
    • Microbiological Resistance – The misconception that micro-organisms will develop resistance over time to the use of disinfectants.
    • Disinfection Rotation – The misconception that disinfection rotation is required to prevent microbiological resistance (i.e., Myth #1).
    • Effectiveness of Isopropyl Alcohol¬ – The misconception that 70% Isopropyl Alcohol (IPA) is effective for control of fungal and bacterial spores.
     

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    9:45

    Container Closure Integrity and Controls Strategies Ensuring Product Sterility

    Lin Tan, CCIT Scientist, AstraZeneca

    • Explore and learn when the utilize the different container closure integrity (deterministic and probabilistic) test methods mentioned in FDA guidance and USP <1207>
    • New technologies with increased sensitivity…what is a good detection limit to target and when to draw the line
    • How and when to utilize microbial challenge to help set manufacturing parameters
    • Holistic approach in defining your container closure integrity controls strategy and aseptic assurance
     

    clock

    10:20

    Morning Coffee

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    10:50

    Online Microbial Monitoring for Process Control of Pharmaceutical Waters

    James Cannon, Head of OEM and Markets, Mettler-Toledo Thornton

    • Current state of real time microbial detection technology
    • Case studies for the implementation of online microbial monitoring at pharmaceutical facilities
    • Guidance for evaluation and establishment of new microbial limits
    • The Pharmacopeia and Regulatory positions on validation of alternative microbial methods

     

    clock

    11:30

    Commissioning of a brand-new cleanroom facility from the environmental monitoring perspective

    Maria Jose Zafra-Domene, QC Microbiologist, MeiraGTx

    • The challenges of commissioning a brand-new facility
    • Risk assessment of the cleanroom and the processes
    • Establishing a routine Environmental Monitoring programme
     

    clock

    12:05

    Bacterial Endotoxins Test – Why are my CVs so high?

    Veronika Wills, Manager, Technical Services, Associates of Cape Cod

    • What is correlation of variation and how to apply it in BET
    • What causes high CVs in BET
    • How to identify the root of high CVs
    • How to mitigate high CVs 

     

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    12:45

    Networking Lunch

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    13:45

    Annex 1 Revision

    • History of Annex 1
    • Current Annex 1 key elements
    • Early indicators of the changes expected in Annex 1
    • Industry comments regarding the draft published in 2017
    • Where now for Annex 1?
     

    Ian Symonds, Director, Pharmaceutical Consultant, SDA Pharma

    clock

    14:20

    Aseptic Audit Observations

    Di Morris, Audit Manager CAGá, Gsk

    • What auditor/inspector expectations are
    • What audit finding classifications can be used
    • Examples of audit observations
    • Keeping up to date
     

    clock

    14:55

    Microbial Robustness in Product Design

    Mitesh Patel, Principal Microbiologist, GSK

    • Impact of product design on manufacturing
    • Going beyond Pharmacopeia Requirements
    • Assessing the effectiveness of Microbial controls
     

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    15:30

    Afternoon Tea

    clock

    16:00

    Importance of Microbiological Standards for Personalized Medicines and Compounding

    • Review of current trends and practices in EU and US
    • Implementation of technological advancements and other best practices
    • Review of new guidances, guidelines, and regulatory enforcement activities
    • A look into the future of global personalized medicine
     

    Jason McGuire, Vice President, Global Quality, Fagron

    clock

    16:35

    Microbial Risk Assessment for Non-Sterile Oral Dosage Forms

    David Elder, Constultant, David P Elder Consultancy

    • Problem statement
    • Risk Assessments
    • Control strategy
    • Objectionable organisms
    • Conclusions
     

    clock

    17:10

    Chair’s Closing Remarks and Close of Day Two


    Constultant
    David P Elder Consultancy
    Audit Manager CAGá
    Gsk
    Business Development Manager
    Copan Group
    Senior Manager, Microbiology & Aseptic Technique
    Fresenius Kabi
    Director, Pharmaceutical Consultant
    SDA Pharma
    Deputy head Section Microbial safety
    Paul Ehrlich Institut
    Head of OEM and Markets
    Mettler-Toledo Thornton
    Chairman of PHSS and Head of GMP Compliance F Ziel GmbH
    PHSS
    Vice President, Global Quality
    Fagron
    Technical Service Manager
    Steris Corp
    CCIT Scientist
    AstraZeneca
    QC Microbiologist
    MeiraGTx
    Principal Microbiologist
    GSK
    Sterility Assurance Expert
    Boehringer Ingelheim
    Professor and Chair of Bacteriology and Hygiene
    University of Veterinary Medicine Vienna/Mycosafe Consulting
    CEO & Co-Founder
    CTL-MAT
    Market Access Manager
    Copan Group
    QC Technical Officer
    AstraZeneca
    Global solution Manager
    BioMérieux
    Sterile Manufacturing Specialist
    AstraZeneca
    Manager, Technical Services
    Associates of Cape Cod

    Sponsors

    Exhibitors

    Official Media Partner

    Supporters

    Workshops

    Pharmaceutical Microbiology Workshop Day

    Pharmaceutical Microbiology Workshop Day

    Copthorne Tara Hotel
    22 January 2020
    London, United Kingdom

    Current Attendees 2020

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    Speaker interview with Ian Symonds

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    Speaker Interview with Olivier Chancel

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    Speaker Interview with David Elder

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    Speaker Interview with Gabriele Savoldi

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    Speaker Interview with James Cannon

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    Speaker interview with Dr. Ingo Spreitzer

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    Pharmaceutical Microbiology UK Infographic

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    Chair Invite Letter

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    Pharma Microbiology Workshop Day 22 Jan 2020

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    Pharma Microbiology 2020 Speakers

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    Pharmaceutical Microbiology UK Brochure 2020

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    Pharma Microbiology 2020 2-day agenda

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    Past Attendees 2017-2019

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    PAST PRESENTATION 2019 - Di Morris - GSK

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    PAST PRESENTATION 2019 - Laurent Leblanc - Biomerieux

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    PAST PRESENTATION 2019 - Thierry Bonnevay - Sanofi Pasteur

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    PAST PRESENTATION 2019 - Olivier Chancel - Boehringer Ingelheim

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    PAST PRESENTATION 2019 - Dr. Sonia Allibardi - COPAN Italia

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    Sponsors


    Associates of Cape Cod

    Sponsors
    http://www.acciusa.com/acc/index.html

    Specializing in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod, Inc. (ACC) has been a leader in endotoxin and (1- > 3)-ß-D-glucans detection products and services for nearly 45 years. ACC pioneered LAL testing methodology and was the first FDA licensed company to manufacture LAL reagents.


    bioMérieux

    Sponsors
    http://www.thepeoplebehindthescience.com

    bioMérieux provides a wide range of solutions for microbiological control dedicated to the pharmaceutical industry. bioMérieux provides solutions for in-process controls and final product testing. From surface and personnel monitoring to air sampling, microbial detection and identification, bioMérieux helps the pharmaceutical industries manage microbiological risks and achieve compliance.


    COPAN

    Sponsors
    http://www.copangroup.com

    With a rightful reputation for innovation, COPAN is the world leading manufacturer of collection and transport systems. In like manner, COPAN’s collaborative approach to pre-analytics has resulted in the development of FLOQSwabs®, ESwab®, UTM® and modular laboratory automation, WASP® and WASPLab®. For further information on COPAN, visit www.copangroup.com


    CTL-MAT

    Sponsors
    https://www.ctlmat.com/

    CTL-MAT - The MAT Company has been established to serve any and all of your Monocyte Activation Test needs, offering MAT Kits, Pooled PBMC, Batch Release Testing, Product-specific Validation and Consultation Services. The MAT is the only quantitative, in-vitro, true pyrogen test - measuring endotoxins and non-endotoxin pyrogens alike.


    METTLER TOLEDO

    Sponsors
    http://www.mt.com

    Mettler-Toledo Process Analytics is a global leader in process and pure water monitoring instrumentation used in pharmaceutical and biotech applications, offering systems for the measurement parameters of Conductivity/Resistivity, pH/ORP, dissolved oxygen, TOC, dissolved CO2, and dissolved ozone. METTLER TOLEDO's innovation continues with the introduction of the 7000RMS analyzer for online microbial monitoring directly from pharmaceutical waters.

    Exhibitors


    Microbiologics

    Exhibitors
    http://www.microbiologics.com

    At Microbiologics, our mission is: "To provide the highest quality biomaterials for a safer, healthier world." We are the leading provider of ready-to-use QC microorganisms for quality control testing in the clinical, pharmaceutical, food, water and educational industries. With over 900 strains available in a variety of user-friendly formats, we offer the largest and most diverse line of QC microorganisms including qualitative, quantitative, Certified Reference Material and Parasite Suspensions. Our products are manufactured in accordance with the industry’s highest standards. We have achieved ISO 13485 certification, as well as ISO 17025 and ISO Guide 34 accreditations. In addition, we are an FDA registered establishment and offer many CE Marked products.


    Microgenetics

    Exhibitors
    https://www.microgenetics.co.uk/smartcontrol

    Innovation is at our core. It is, after all, the reason we formed back in 2014 when our sister company Bath ASU needed a new, smarter method for microbiological environmental monitoring. As a result, our passionate team has developed products that innovate microbiology and molecular diagnostic technologies for the pharmaceutical industry, kickstarting our mission to help win the war against pathogens. SmartControl EM is our environmental monitoring software; built in line with EU GMP Annex 11 and FDA CFR Part 11, it helps users meet regulation, enhance data integrity and take better environmental monitoring decisions. Also in the SmartControl family, our Colony Counter uses Machine Learning to automate the slow and error-prone colony counting process, even for complex plates such as environmental monitoring samples. Finally, SwiftDetect is our rapid sterility test, capable of testing down to a single cell of contamination, harnessing results in under 6 hours.



    RSSL

    Exhibitors
    http://www.rssl.com

    RSSL provides analytical, investigational, consultancy and training services to clients in the global pharmaceutical, biopharmaceutical and healthcare industries. Our GMP compliant facilities are located in the UK and with our team of more than 300 dedicated employees, we ensure that every project is performed with our commitment to outstanding quality, scientific excellence and customer satisfaction. We offer a large portfolio of, chemical, physical, biochemical and microbiological services providing support through the full drug product life cycle.


    Veltek Associates Inc

    Exhibitors
    www.sterile.com

    Veltek Associates, Inc. (VAI) is an EPA/FDA registered manufacturing facility, specialising in contamination control. Our range of sterile disinfectants, sporicides, wipes and process cleaning detergents, complement our sterile, disposable cleanroom garments which offer comfortable, breathable garments with outstanding particulate performance. Along with our environmental air sampling equipment to determine levels of contamination present in the air, Veltek is committed to providing our customers with the highest quality products.

    Media Partners


    Rapid Microbiology.com

    Official Media Partner
    https://www.rapidmicrobiology.com

    rapidmicrobiology.com is a well-established on-line resource for microbiologists worldwide, find the right products for your microbiology lab using our specially designed search functions. To keep up-to-date with the latest microbiology news get our free weekly newsletter which includes updates on products, services, webinars, training courses and conferences.

    Media Partners


    SciDoc Publishers

    Supporters
    http://www.scidoc.org

    SciDoc Publishers is a major source provider of e-journals in the field of Science, Technology and Medicine (STM). The nature of journals - Open Access and Peer-reviewed. We are aimed with a sole motive in making a mark in the field of Open Access, by propagating the knowledge to the scientific community. Our prime concern involves, the knowledge to reach millions of readers and give them access to scientific publications - online.


    Pharmavision

    Supporters
    http://www.pharmavision.co.uk

    PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.


    pharmaphorum

    Supporters
    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


    Gate2Biotech

    Supporters
    http://www.gate2biotech.com

    Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.


    Mednous

    Supporters
    http://www.MedNous.com

    MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


    MedTube

    Supporters
    https://medtube.net/



    World Pharma News

    Supporters
    http://www.worldpharmanews.com/



    Swiss Biotech Association

    Supporters
    http://www.swissbiotech.org/

    The Swiss Biotech Association (SBA) is the national industry association for biotechnology, including pharmaceuticals, diagnostics, agriculture, food, cosmetics, environmental biotechnology, and specialty chemicals. Members are companies active in modern biotechnology, such as R&D, Production, Marketing and Sales, Finance, Services and Consulting. SBA provides a networking platform for Life Science clusters, academic and federal institutions the like. Founded in March 1998, the Association grows steadily.


    Farmavita

    Supporters
    https://farmavitar.com

    FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa. Management of international, multi-centre projects is our core competence. FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance. FarmavitaR+ is brand name of Farmavita Regulanet Ltd. Visit https://farmavitar.com for more information. Outsource anything you can think of!


    Genetic Engineering News

    Supporters
    http://www.genengnews.com

    Genetic Engineering & Biotechnology News (GEN) is the most authoritative and widely read biotechnology news publication in the world.Published 21 times a year,GEN's unique news and technology focus include the entire bioproduct life cycle from early-stage R&D to applied research and bioprocess through to commercialization. GEN is the only publication that provides the full range of the biotechnology market coverage in areas such as omics, drugs and biomarker discovery, bioprocessing, clinical research, molecular diagnostics and biobusiness. For a free subscription go to: http://www.genengnews.com/subscriptions.aspx


    Pharmalicensing

    Supporters
    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.


    Drug Target Review

    Supporters
    http://www.drugtargetreview.com

    Drug Target Review’s quarterly magazine, website and annual events program provides high quality content with peer-written articles that are submitted exclusively by the world’s most respected scientists in their field. This attracts a committed base of readers, users and delegates made up of senior decision-makers from the life science and drug discovery industries at the top pharmaceutical companies, as well as academics and scientists from the top research institutes across the globe.


    Biocompare

    Supporters
    http://www.biocompare.com

    Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.


    Drug Development Technology

    Supporters
    http://www.drugdevelopment-technology.com

    Drugdevelopment-technology.com covers every aspect of the drug development and research process, from conception to pre-FDA approval. Our global network of journalists updates the site with the latest and most significant industry developments. This coverage allows us to provide everyone - from senior management through to research and QA staff – with in-depth reviews of the latest projects, advance notice of new product releases and analysis of the latest procedural and legislative developments.


    Drug Discovery Today

    Supporters
    http://www.drugdiscoverytoday.com/

    Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.


    IPI

    Supporters
    http://www.ipimediaworld.com

    IPI – International Pharmaceutical Industry Established by professionals with over 30 years experience in the Pharmaceutical and Life sciences publishing sectors. We have identified the needs of these dynamic industries, and have listened carefully to our readers and advertisers. With strong collaboration between Pharmaceutical and Life sciences Industry Associations we have created a global distribution network. We give you a promise to become a reliable extension of your marketing and communication arm. If necessary we will integrate our expertise with your needs. Incorporating new and innovative communication methods we will help to highlight your expertise.


    Contract Biotechnology

    Supporters
    http://www.contract-biotechnology.com

    Contract-Biotechnology.com is a web-based platform for laboratory outsourcing solutions. It is an online R&D matching tool that connects Scientifics and service and product providers worldwide. The platform Contract-Biotechnology.com would help you in the process of finding the right partner saving time and money, because with one single and secure application you would be able to receive multiple quotes quickly, keeping your contact information confidential. Contract-Biotechnology.com is the new Collaboration Network Model for Discovery Research and Development. Contract-Biotechnology.com team has extensive experience working for pharmaceuticals, biotechs, universities and academic research institutes and can help you addressing your key gaps.


    American Pharmaceutical Review

    Supporters
    http://www.americanpharmaceuticalreview.com

    Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy


    Pharmaceutical Technology

    Supporters
    http://www.pharmaceutical-technology.com

    Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.

    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    HOTEL BOOKING FORM

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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