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Pharmaceutical Microbiology East Coast
April 27 - April 28, 2022
Pharmaceutical Microbiology East Coast

SAE Media Group’s 5th Annual Conference
Pharmaceutical Microbiology East Coast
April 27-28 2022 | Boston, USA
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Microbiology remains an essential tool in reducing microbial growth in the manufacture of pharmaceuticals, to detect and eliminate microorganisms that would pose a risk to patients and jeopardise product batches.


Ensuring the sterility of the finished product continues to be one of the most critical aspects of drug development, however an array of factors are also sustaining new growth and transformation in this field. The regulatory landscape is changing, firstly with the preparation of Annex I, in addition to increasing requirements pertaining to data integrity. Light is being shed on recent product recalls for mould contamination, and infection outbreaks serve as a reminder to pay more attention to these overlooked organisms, as well as considerations towards container closure integrity testing which is being increasingly deployed to block microbe movement.


On top of this, the developing integration of automation and robotics into the manufacturing pipeline, as well as the increased need for more rapid microbiology methods brought about in part by the surge in ATMPs, are all highlighting the necessity of the field in Pharma.
This industry is ever expanding -- join leading experts in 2022 to discuss and analyse the latest advances and challenges surrounding Pharmaceutical Microbiology. Network with industry professionals, discuss revisions in regulatory and guidance documents, and gain a deeper insight into this corner of the field.


To register your interest or to get involved please contact: eshambler@SAE Media Group-online.co.uk
 

FEATURED SPEAKERS

Alison Laughlin

Alison Laughlin

Associate Director, Regional Quality NA & Sterility Process Assurance, Boehringer Ingelheim
Dawn Watson

Dawn Watson

Director, Microbial Control, MSD
Donald Singer

Donald Singer

Senior Microbiology Technical Consultant, North America, and Chair, USP General Chapters- Microbiology Expert Committee, Ecolab & US Pharmacopeia
Hilary Chan

Hilary Chan

Principal Quality Control Scientist, Takeda
Jim Polarine

Jim Polarine

Senior Technical Service Manager, Head of Microbiology & Sterile Technology, STERIS Corporation
John Arigo

John Arigo

Director, Division of Microbiology Assessment , Office of Pharmaceutical Manufacturing Assessment / FDA
Lena J Hoch

Lena J Hoch

Microbiologist Specialist, Quality Control Microbiology - Projects, GSK
Lynne Ensor

Lynne Ensor

Vice President, RCS Head of Global Compliance, Parexel International
Mauro Giusti

Mauro Giusti

Senior Director, Site External Network, Eli Lilly Italia
Michael Song

Michael Song

Associate Director, Takeda Pharmaceutical Company Limited
Veronika Wills

Veronika Wills

Manager, Technical Services, Associates of Cape Cod
Yoko Nakai

Yoko Nakai

Rapid Microbiological Method RMM Research Group Representative, PDA Japan chapter

Alison Laughlin

Associate Director, Regional Quality NA & Sterility Process Assurance, Boehringer Ingelheim
Alison Laughlin

Alison Laughlin is the Associate Director of North America Regional Quality & Global Sterility Process Assurance for the Animal Health Division of Boehringer Ingelheim. She has over 25 years of technical expertise in sterility assurance, environmental monitoring, and microbiological testing of sterile pharmaceuticals, vaccines, and medical devices. Her expertise includes leading root cause investigations for complex microbiological issues and improving regulatory compliance and product quality. She currently develops divisional policies and procedures and provides quality support to the North America Boehringer Ingelheim Animal Health division sites and sterility assurance support to the global sites. Her prior roles included leadership positions in the Microbiology Laboratories at Baxter Healthcare, Hospira, and Wyeth. Alison holds a bachelor’s degree in Biology from Rutgers University, New Jersey.

Dawn Watson

Director, Microbial Control, MSD
Dawn Watson


Dawn is a Director supporting Microbial Control at MSD. She works in the Sterile & Validation Center of Excellence managing a team that leads and executes global initiatives targeted to proactively address quality and compliance risks in the sterile and low bioburden network while driving continuous improvement. Additionally, her team provides microbial contamination control and sterile manufacturing expertise to resolve critical production issues, develop innovative solutions, and ensure network alignment with industry and regulatory expectations. She is an active member in the Parenteral Drug Association and BioPhorum Operations Group. She has 26 years of experience in the pharmaceutical industry, specifically focused on sterile and low bioburden products including vaccines, therapeutic proteins and small molecules. She is trained and certified in Six Sigma and Change Management. She has held positions in validation, manufacturing and research and development throughout her career with MSD.
 

Donald Singer

Senior Microbiology Technical Consultant, North America, and Chair, USP General Chapters- Microbiology Expert Committee, Ecolab & US Pharmacopeia
Donald Singer

Don Singer is Senior Microbiology Technical Consultant, N.A. for Ecolab, and a Fellow in the American Society for Quality. Don is currently Chair of the USP Microbiology Committee of Experts and has been a member of this committee since 2000. Don is a member of the European Pharmacopeia Group 1 Microbiology Committee. He is also chair of the PDA Task Force for the revision of Technical Report titled, “Pharmaceutical Package Integrity Testing”, and was co-author of the TR “Exclusion of Objectionable Microorganisms”. He is a Certified Specialist Microbiologist (NRCM) and Certified Pharmaceutical GMP Professional (ASQ), and a former Malcolm Baldrige National Quality Award Examiner. Don’s career spans over 40 years of research, quality control, quality assurance experience in the pharmaceutical, biopharmaceutical, personal care, cosmetic, and food industries. Currently Don is also an adjunct instructor in the Biopharmaceutical Quality graduate program at University of Maryland Baltimore County.

Fred Ohsiek

Sr Validation Manager instead of Sr Global Technical Manager, Novo Nordisk
Fred Ohsiek

Fred Ohsiek is the Sr Cleaning Validation Specialist for Novo Nordisk in Clayton, NC. He earned his bachelor’s in chemistry from University of South Florida. His professional work experience includes 7 years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and over 20 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Ben Venue Laboratories, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk.
His cleaning validation experience includes risk assessments, cleaning development, validation, and monitoring cleaning processes for equipment used to manufacture small molecule [oral dose (solid and liquid) and parenteral], peptide hormone encased (parenteral), and large molecule (biotech) pharmaceutical, OTC, and nutritional products. The scope of his work involved drug substance and drug product manufacturing start-up, remediation, legacy justification, and increasing manufacturing capability. He has created lean CV strategies for document structure/flow and execution in every aspect of the cleaning validation process.
He was one of the authors on the new ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and the cleaning validation acceptance criteria chapter lead.

Hilary Chan

Principal Quality Control Scientist, Takeda
Hilary Chan

Hilary Chan is a Principal Quality Control Scientist in Global Microbiology Management at Takeda and is based out of Lexington, MA. In her current role, Hilary is responsible for leading various technical improvement initiatives related to microbiological issues/contamination control for Takeda’s global manufacturing operations. She is a business process owner for environmental monitoring as well as a contamination control community of practice network lead for Takeda. She is an invited speaker at industry conferences and has authored various scientific publications. Hilary has over 20 years of experience in the biotech industry and holds a Bachelor’s degree in Zoology from Colorado State University and a Master’s degree in Biomedical Science from Northeastern University.

Jim Polarine

Senior Technical Service Manager, Head of Microbiology & Sterile Technology, STERIS Corporation
Jim Polarine

Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for twenty 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, microbial control in cleanrooms and validation of disinfectants. 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 on the PDA’s COVID-19 Task Force and the PDA’s Microbial Excursions Task Force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. Mr. Polarine teaches industry regulators as well as the pharmaceutical, biotech, and medical device industries at the PDA and the University of Tennessee. Mr. Polarine currently teaches the cleaning and disinfection course as part of the PDA Aseptic Processing Course, IEST, and at the University of Tennessee Parenteral Medications Course. Mr. Polarine is the current President for the PDA Missouri Valley Chapter and Technical Coordinator for the IEST. He is also a leader on the PDA’s Chapter Council Steering Committee. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology. He previously worked as a clinical research manager 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.

John Arigo

Director, Division of Microbiology Assessment , Office of Pharmaceutical Manufacturing Assessment / FDA
John Arigo

Dr. Arigo is the Director of the Division of Microbiology 1 in the Office of Pharmaceutical Manufacturing Assessment at the FDA. His division assesses the sterility assurance and manufacturing submissions to support ANDA, NDA, and INDs. He began his career with the Office of Generic Drugs Microbiology team in 2008 and has been involved in multiple reorganizations to the current state. Dr. Arigo obtained his Ph.D. from The Johns Hopkins University School of Medicine.

Kate Young

Manager, QA Specialist - Vector CMOs, Bristol Myers Squibb
Kate Young

Lena J Hoch

Microbiologist Specialist, Quality Control Microbiology - Projects, GSK
Lena J Hoch

Lena J Hoch is a Microbiologist Specialist with GlaxoSmithKline in Pennsylvania where she has held various positions over the past six years specializing in microbiology and supporting quality control. Prior to these roles, she attended University of the Sciences in Philadelphia and earned a BS in Biology with minors in Microbiology and Humanities. She is a subject matter expert for GSK's Quality Control Microbiology department and currently specializes in low endotoxin recovery and project management activities.

Lynne Ensor

Vice President, RCS Head of Global Compliance, Parexel International
Lynne Ensor

Dr. Lynne Ensor is the Vice President, RCS Head of Global Compliance, for Parexel International and has been employed there since August 2019. As a 21-year veteran of the U. S. Food and Drug Administration (FDA), her areas of expertise include biopharmaceutical sterile product manufacturing and testing (CMC and cGMP), risk assessment and mitigation strategies, data integrity assessment, regulatory policy and guidance development, as well as remediation strategies for product and facility challenges (e.g., resolving consent decrees, warning letters, 483 observations, and drug shortages). While serving as the Deputy Director (Acting) in the Office of Process and Facilities (OPF) within FDA/Center for Drug Evaluation and Research’s (CDER) Office of Pharmaceutical Quality (OPQ), she was responsible for new, generic and biologic drug product quality review and facility assessment. Dr. Ensor’s previous FDA positions included serving as the Director of the OPF’s Division of Microbiology Assessment, Director of the Office of Pharmaceutical Science’s New and Generic Drug Product Quality Microbiology staff, Director of the Office of Generic Drugs’ Division of Microbiology and as a CDER master CMC reviewer. In addition to Dr. Ensor’s regulatory experience, Lynne was employed at Roche Biomedical Laboratories, served as a post-doctoral research fellow at the University of Maryland at Baltimore’s School of Medicine, and served as a script consultant for the Discovery Channel. She earned her B.S. in Biology and Ph.D. in Microbiology from the University of Maryland, College Park.

Mauro Giusti

Senior Director, Site External Network, Eli Lilly Italia
Mauro Giusti

Dr. Mauro Giusti holds a Master Degree in Chemistry at University of Florence, he is Board Certified by National Chemist association and he is Board certified as Technical Director (Qualified Person) by the Italian Minister of Health.
After serving as Army Officer, he joined Eli Lilly at the Italy manufacturing plant site in 1988. Over the 33 years with Eli Lilly, Dr. Giusti has covered several positions within the Lilly Manufacturing organization (Regulatory, Technical Services, Project Management, QC, QA, Operations, Technical Director/Qualified Person, Six Sigma Champion, Science and Technology, Procurement), dealing both with Lilly manufacturing plants as well as with Contract manufacturing in the Europe/Africa/Asia.
Among the several experiences with Lilly, he has worked in USA from 1992 to 1994 and in United Kingdom from 1997 to 1999..
Since late 2003, he has had responsibility for Lilly Italy TSMS (Technical Svcs/Mfg Science Department), with responsibility for Metrology, C&Q of facilities, utilities and equipment, Sterility Assurance, Process Validation, set-up of new manufacturing processes and of new manufacturing technology for Biotech products, including automatic assembly of disposable Insulin pens and Autoinjectors. In September 2009 he also added to his TSMS duties, the responsibility for Manufacturing Sourcing and Vendor Management.
In September 2019 he has taken a new role, as Advisor, Site External Network, dealing with external entities linked to the Lilly Sesto Manufacturing site (Universities, Pharma Associations, etc..) and leading a Lilly Global project for improvement of technical capabilities in Parenteral Manufacturing.
For more than 12 years he has served as a member of the Italy Chapter of PDA, with several participations to national and international forum both as speaker and as chairman. In November 2019 he has been appointed as Co- Chair for he Process Validation Interest Group. In August 2020 he has been appointed to the PDA Science Advisory Board (SAB).
 

Michael Song

Associate Director, Takeda Pharmaceutical Company Limited
Michael Song

Michael currently is Associate Director of Device Development at Takeda. Prior to his current role he was head of Combination Product Manufacturing at Heron Therapeutics where he led medical device and combination product commercial readiness. Prior to Heron, he formed and led the Device Functionality, Safety and Digital Connectivity group at AstraZeneca where his group oversaw device functionality portion of device development; primary container science and technology; biocompatibility; container closure integrity programs; and digital connectivity. Prior to AstraZeneca, he was head of Device, Package, and Process Engineering at Adello Biologics, a member of Amneal Pharmaceutical. He also has held key engineering lead and toxicology SME positions at Stryker, Kavlico, and other companies. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

Veronika Wills

Manager, Technical Services, Associates of Cape Cod
Veronika Wills

Veronika has over 13 years experience in endotoxin testing, and currently manages the global technical team at ACC and is based at ACC’s US Headquarters in East Falmouth, Massachusetts . Veronika is a subject matter expert when it comes to endotoxin testing and often provides expert sessions at global events focused on BET products and processes. Most recently Veronika has been speaking on the topic of recombinant technology as it relates to BET in the industry and abroad. Veronika is a key contributor to ACC’s sustainability initiatives and spokesperson on ACCs related projects, products and services.

Yoko Nakai

Rapid Microbiological Method RMM Research Group Representative, PDA Japan chapter
Yoko Nakai

The GMP Committee for Aseptic Products is one of the technical committees of PDA Japan chapter. It is made up of ten groups, each with experts in their respective fields who are actively engaged in research and discussion. Study results of each group have been reported at annual microbiology symposium which the committee hosted and provided participants state-of-art and practical information.
One of the groups, the Rapid Microbiological Method (RMM) Research Group consists of RMM users (pharmaceutical companies) and RMM system suppliers. By their collaboration, they provide application and implementation case studies from scientific, engineering, and regulatory point of view, and contribute to further improvements of quality and safety of pharmaceutical products by wide use of RMM in Japan.
The speaker, Yoko Nakai represents the GMP Committee for Aseptic Products. She has been a project manager for RMM system development and applications at HORIBA Advanced Techno, Co., Ltd. since 2017. HORIBA has been a member of RMM implementation study team with Bayer Yakuhin, Ltd., and Azbil Corporation.
 

sponsors

Conference agenda

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8:30

Registration & Coffee

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9:00

Opening Remarks

Fred Ohsiek

Fred Ohsiek, Sr Validation Manager instead of Sr Global Technical Manager, Novo Nordisk

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9:10

Session 1

Fred Ohsiek

Fred Ohsiek, Sr Validation Manager instead of Sr Global Technical Manager, Novo Nordisk

  • Quick review of regulatory requirements and guidelines 
  • Initial cleaning validation risk assessment
  • Building the CV program using the risk assessment
     
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    9:50

    Session 2

    Fred Ohsiek

    Fred Ohsiek, Sr Validation Manager instead of Sr Global Technical Manager, Novo Nordisk

  • Stage 1 cleaning validation documents
  • Stage 2 cleaning validation documents
  • Essential cleaning validation documents
  • Lean CV protocols and execution
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    10:20

    Morning Coffee

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    10:50

    Session 3

    Fred Ohsiek

    Fred Ohsiek, Sr Validation Manager instead of Sr Global Technical Manager, Novo Nordisk

  • Quick review of FDA 2011 Continued Process Verification (CPV) regulatory guidelines
  • In-depth discussion on periodic review, CPV, and dated validation packages
  • Risk-Based approaches to Continued Process Verification
  • Reducing routine monitoring frequency
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    11:30

    Session 4

    Fred Ohsiek

    Fred Ohsiek, Sr Validation Manager instead of Sr Global Technical Manager, Novo Nordisk

  • Case study for determining CPV frequency and testing and then reducing frequency
  • Case study for re-validating legacy cleaning processes
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    12:10

    Closing remarks

    Fred Ohsiek

    Fred Ohsiek, Sr Validation Manager instead of Sr Global Technical Manager, Novo Nordisk

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    14:00

    Opening Remarks

    Donald Singer

    Donald Singer, Chair, General Chapters - Microbiology Expert Committee, Ecolab

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    14:10

    How Do I Best Use the USP?

    Donald Singer

    Donald Singer, Chair, General Chapters - Microbiology Expert Committee, Ecolab

  • Monographs and General Notices
  • Benchmarking with General Information
  • Standards, Resource, Teaching Tool
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    14:40

    Latest Revisions in USP45 and Beyond

    Donald Singer

    Donald Singer, Chair, General Chapters - Microbiology Expert Committee, Ecolab

  • B. cepacia Test <60>
  • Microbial Tests for Sterile Short Shelf-Life Products <1071>
  • Sterilization topics <1229.16> <1229.17>
  • Guidelines on Bacterial Endotoxins Test <1085>
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    15:20

    Coffee Break

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    15:50

    Latest Proposed Revisions in USP PF

    Donald Singer

    Donald Singer, Chair, General Chapters - Microbiology Expert Committee, Ecolab

  • Tests for ATMPs
  • Microbiology Best Laboratory Practices <1117>
  • Disinfectant Efficacy Testing <1072>
  • Validation of Alternatives for Bacterial Endotoxin Test <1085.1>
  • New Sterilization topics <1229.n>
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    16:30

    New Activities and Innovative Committee Thinking

    Donald Singer

    Donald Singer, Chair, General Chapters - Microbiology Expert Committee, Ecolab

  • Controls for Cell and Gene Therapy Manufacturing
  • Containment and Contamination Control Monitoring
  • Alternative Microbiological Tests and Comparability
  • Will the Real Objectionable Microorganism Stand Up?
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    17:10

    Closing Remarks

    Donald Singer

    Donald Singer, Chair, General Chapters - Microbiology Expert Committee, Ecolab

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    8:00

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Jim Polarine, Senior Technical Service Manager, Head of Microbiology & Sterile Technology, STERIS Corporation

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    9:10

    Designing an Efficient Disinfectant Efficacy Program

  • Review disinfectant efficacy validation and implementation guidance
  • How to leverage multi-site data to reduce redundancies in validation or verification and to efficiently qualify disinfectants without impacting the quality of the study
  • Case studies will be presented from two companies discussing global disinfectant efficacy studies that support and supplement site disinfectant efficacy programs
  • Hilary Chan, Principal Quality Control Scientist, Takeda

  • Review disinfectant efficacy validation and implementation guidance
  • How to leverage multi-site data to reduce redundancies in validation or verification and to efficiently qualify disinfectants without impacting the quality of the study
  • Case studies will be presented from two companies discussing global disinfectant efficacy studies that support and supplement site disinfectant efficacy programs
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    9:50

    Implementing a Contamination Control Strategy

    Alison Laughlin, Associate Director, Regional Quality NA & Sterility Process Assurance, Boehringer Ingelheim

  • Elements of a Robust Contamination Control Strategy
  • Best Practices for Implementing a Contamination Control Strategy
  • Documenting the Contamination Control Strategy
  • The Benefits of a Well-Defined Contamination Control Strategy
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    10:30

    Morning Coffee

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    11:00

    Legacy Cleaning Validation Concerns and The Solution

    Fred Ohsiek, Sr Validation Manager instead of Sr Global Technical Manager, Novo Nordisk

  • Quick review of regulatory guidelines for maintaining the validated state 
  • Legacy cleaning validation concerns and pitfalls
  • Explore the benefits for re-validating legacy cleaning processes 
  • Tour and examine the re-validation process
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    11:40

    Recombinant reagents for BET – regulatory landscape and their future in routine use

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

    • Overview of the types of available recombinant technologies and key differences
    • The regulatory landscape around the use of recombinant reagents as alternatives to LAL reagents
    • Product specific method validation approach
    • The future applications of recombinant reagents
    • Automation of the use of recombinant reagents
     

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    12:20

    Networking Lunch

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    13:20

    A Risk Assessment Approach to Address Fungal Spore Contamination in a Cell and Gene Therapy Cleanroom

    Jim Polarine, Senior Technical Service Manager, Head of Microbiology & Sterile Technology, STERIS Corporation

  • Case studies on fungal spore contamination in Cell and Gene Therapy Facilities will be covered
  • Investigative methods including risk assessments, fishbone diagrams and the five why’s will be discussed
  • Technologies for fungal spores’ control and methods to proactively prevent fungal outbreaks will be interactively discussed
  • Industry best practices for cleaning and disinfection of cell and gene therapy facilities will be highlighted
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    14:00

    Impacts of the SARS-CoV-2 pandemic on the biopharmaceutical industry

    Lynne Ensor, Vice President, RCS Head of Global Compliance, Parexel International

    • The impact of the COVID-19 pandemic on the following areas will be discussed during the presentation:
            o Regulatory Emergency Use Authorizations and Final Approval Process
            o Regulatory Manufacturing Facility Assessment and Inspections
            o Manufacturing Facility Design
            o Supply Chain Integrity Considerations

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    14:40

    Afternoon Tea

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    15:10

    Common Issues in The Sterility Assurance Assessment

    John Arigo, Director, Division of Microbiology Assessment , Office of Pharmaceutical Manufacturing Assessment / FDA

    • Introduction to FDA small molecule microbiology/ manufacturing
    • Common deficiencies seen in applications
    • Recommendations for applications to expedite approval

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    15:50

    Microbial control: Risk assessment of traditional culture-based microbiological tests requiring contemporaneous verification

    Lena J Hoch, Microbiologist Specialist, Quality Control Microbiology - Projects, GSK

    The FDA is particularly focused on the data integrity of microbial tests as these often use manual methods that could be open to error or fraud
    • A BioPhorum survey into this area found that more than 50% of members were doing second-person verification of tests to satisfy FDA scrutiny, but did not think the risk was being properly managed
    • The presentation looks at the fundamentals of ensuring microbiological test data integrity and proposes that a qualitative risk assessment is performed for the traditional, culture-based quality control tests that currently require verification by a second person. In addition, lab controls are recommended to ensure that testing is robust
    • One member company applied the risk assessment approach outlined in the paper and was able to remove 12 million second person verification samples from its global testing program. A case study also demonstrated that it is possible to save one to two full time equivalents if the risk-based approach is applied
    • The workstream members are now implementing this approach and sharing both operational experience and feedback at audit. The recommendations outlined are currently being considered for incorporation into an update of USP 1117

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    16:30

    Chair’s Closing Remarks and Close of Day One

    Jim Polarine, Senior Technical Service Manager, Head of Microbiology & Sterile Technology, STERIS Corporation

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    8:30

    Registration & Coffee

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    9:00

    Chair's Opening Remarks

    Jim Polarine, Senior Technical Service Manager, Head of Microbiology & Sterile Technology, STERIS Corporation

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    9:10

    Case Study: Expediting Mold Contamination Investigations with the Use of Biofluorescent Particle Counting Technology

    Dawn Watson, Director, Microbial Control, MSD

    • This presentation will provide an overview of the rapid microbiological technology used, specifically BFPC
    • It will provide a case study for the application of BFPC technology to support mold remediation in an aseptic processing facility
    • The presentation will review the benefits and outcomes yielded with use of the BFPC technology to support resolution of an investigation
    • The presentation will provide opportunities for additional use of the BFPC technology to ensure successful return to operation following major shutdowns, facility modifications or breaches

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    9:50

    Microbiological quality control for pharmaceutical water by Rapid Microbiological Methods (RMM)

    Yoko Nakai, Rapid Microbiological Method RMM Research Group Representative, PDA Japan chapter

    • The GMP Committee for Aseptic Products of the PDA Japan chapter will present case studies applying RMM, for monitoring microbial quality of pharmaceutical water
    • Two different methods are implemented, BFPC (Bio Fluorescent Particle Counter) and high-sensitivity ATP method
    • Discussion will be held based on the data obtained at the pharma factory over several years and the laboratory of the system supplier
    • The case studies will cover setting an action/alert level for achieving GMP operation
     

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    10:30

    Morning Coffee

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    11:00

    Steps to eradicate undetected contaminations using bioburden anaerobic testing

    Kate Young

    Kate Young, Manager, QA Specialist - Vector CMOs, Bristol Myers Squibb

  • With no standard optimized testing methods, it is possible for anaerobic contaminants to go undetected in biological manufacturing processes
  • This is a risk that could cause significant disruption to manufacturing processes
  • This presentation outlines testing options using case studies from 6 global pharmaceutical companies, who are members of the BioPhorum Microbial Control workstream
  • The recommendations were vetted via an independent and blinded peer-review process involving other leading industry experts
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    11:40

    Combination Product Sterility Assurance – A holistic approach from component through manufacturing

    Michael Song, Associate Director, Takeda Pharmaceutical Company Limited

    • Developing a holistic container closure integrity (CCI) strategy from component level through manufacturing to finish good
    • Methods and approaches for primary container component selection and qualification
    • Container closure integrity testing (CCIT) to establish robust manufacturing processes
    • Altitude impact on sterile barrier and approaches to demonstrate sterility is maintained during air transportation

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    12:20

    Networking Lunch

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    13:20

    Panel Discussion: Assessing the ongoing coronavirus pandemic and the changing face of the pharmaceutical industry

    • How has the regulation changed in response to the pandemic?
              o Are these changes here to stay?
    • Can operational protocols be implemented in manufacturing facilities to ensure personnel safety and minimise viral transmission?
    • Has the pharmaceutical industry addressed flaws in the supply chain highlighted by the pandemic?
    • Do novel SARS-CoV-2 variants pose a future threat to the industry?
              o How do we best prepare for future outbreaks?

    Jim Polarine, Senior Technical Service Manager, Head of Microbiology & Sterile Technology, STERIS Corporation

    Lynne Ensor, Vice President, RCS Head of Global Compliance, Parexel International

    Donald Singer, Senior Microbiology Technical Consultant, North America, and Chair, USP General Chapters- Microbiology Expert Committee, Ecolab & US Pharmacopeia

    Mauro Giusti, Senior Director, Site External Network, Eli Lilly Italia

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    14:00

    Isolator technology: from project to operations

    Mauro Giusti, Senior Director, Site External Network, Eli Lilly Italia

    • Sharing experiences on multiple filling lines with Isolator technology
    • Recommendations based on experience
    • Specific case studies during operations
    • Discussion on technology options for the process with sterility assurance implications
     

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    14:40

    Afternoon Tea

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    15:10

    Learning to control B. cepacia – A USP perspective

    Donald Singer, Senior Microbiology Technical Consultant, North America, and Chair, USP General Chapters- Microbiology Expert Committee, Ecolab & US Pharmacopeia

    • What have we learned about B. cepacia?
    • The trouble with undefined terminology
    • When to use USP general method <60>
    • What can we learn from USP <1115> to mitigate Bcc problems?
     

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    15:50

    Chair’s Closing Remarks and Close of Day Two


    Associate Director, Regional Quality NA & Sterility Process Assurance
    Boehringer Ingelheim
    Director, Microbial Control
    MSD
    Senior Microbiology Technical Consultant, North America, and Chair, USP General Chapters- Microbiology Expert Committee
    Ecolab & US Pharmacopeia
    Sr Validation Manager instead of Sr Global Technical Manager
    Novo Nordisk
    Principal Quality Control Scientist
    Takeda
    Senior Technical Service Manager, Head of Microbiology & Sterile Technology
    STERIS Corporation
    Director, Division of Microbiology Assessment
    Office of Pharmaceutical Manufacturing Assessment / FDA
    Manager, QA Specialist - Vector CMOs
    Bristol Myers Squibb
    Microbiologist Specialist, Quality Control Microbiology - Projects
    GSK
    Vice President, RCS Head of Global Compliance
    Parexel International
    Senior Director, Site External Network
    Eli Lilly Italia
    Associate Director
    Takeda Pharmaceutical Company Limited
    Manager, Technical Services
    Associates of Cape Cod
    Rapid Microbiological Method RMM Research Group Representative
    PDA Japan chapter

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    Preliminary Attendees List

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    Speaker Interview - Yoko Nakai, PDA Japan Chapter

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    Speaker Interview - Lynne Ensor, Parexel International

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    Speaker Interview - Mauro Giusti, Eli Lilly Italia

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    Speaker Interview - Donald Singer, Ecolab & US Pharmacopeia

    Download

    Speaker Interview - Alison Laughlin, Boehringer Ingelheim

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    Conference Chair Letter

    Download

    Chair & Speaker Biographies

    Download

    Workshops

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    Brochure

    Download

    Past Attendees

    Download

    Past Speaker Presentation - Dr Johannes Reich, Microcoat

    Download

    Past Speaker Presentation - John Arigo, FDA

    Download

    Past Speaker Presentation - Kashyap Bhatt, Takeda

    Download

    Past Speaker Presentation - Jim Polarine, STERIS

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    Past Speaker Presentation - Hilary Chan, Takeda

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    Sponsors


    Associates of Cape Cod

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

    ACC Specializing in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod, Inc. (ACC) has been a leader in endotoxin and (1g3)-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.



    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


    Bioscience International

    Exhibitors
    http://www.biosci-intl.com

    The newest generation of SAS microbial air monitors, for ensuring full compliance with ISO 14698, cGMP and other international monitoring guidelines will be displayed.


    Ecolab

    Exhibitors
    https://en-uk.ecolab.com/

    Ecolab’s Life Sciences division is dedicated to developing the best possible products and services to support our customers in the pharmaceutical industry.

    Our comprehensive solutions and technical expertise are focused on cleaning, sanitisation and contamination control, all while ensuring safety, compliance and operational efficiency.



    Microbiologics

    Exhibitors
    http://www.Microbiologics.com

    Microbiologics is the world’s leading experts and go-to collaborators for biological products and services, focused on protecting the health and safety of people around the world. We partner with pharmaceutical, biotechnology and medical device companies to bring new life-changing diagnostic assays, drugs and vaccines to market safely and efficiently. With a highly collaborative approach, we provide contract research, antimicrobial and antiviral testing, assay development, biomaterial design services and more. As a trusted industry partner with more than 5 decades of experience, our knowledgeable team is ready to answer your questions and get started with designing a customized program to fit your unique project needs.


    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.


    Medical Design Briefs

    Official Media Partner
    http://WWW.TECHBRIEFS.COM/SUBSCRIBE/MDB/SMIEAST21

    Medical Design Briefs (MDB) is the only publication for the medical OEM market dedicated to medical product design engineers and managers. We offer timely, accurate, quality content and editorial, and we report on engineering-related topics that are at the core of the latest medical technologies. From materials to manufacturing, we dive into the technical side of bringing medical devices to market. From biosensors to cybersecurity, we keep our fingers on the pulse of the hottest trends and topics that may augment or disrupt medical technology.


    American Pharmaceutical Review

    Official Media Partner
    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


    Labcompare

    Official Media Partner
    http://www.labcompare.com

    Labcompare is a product of American Laboratory, and is already included in the AL logo on your website. I have attached the standalone Labcompare logo and info is below, but if you do add this one separately, could you exchange the American Lab logo with the one attached? For laboratory managers and researcher scientists across analytical chemistry and applied sciences who need to find product solutions, advice, and access scientific tools. Labcompare provides an industry-leading, comprehensive, online resource of product information to support the laboratory’s needs. Labcompare supports every step of the buying journey by focusing on core and new product technology, supplies, tips, and buyer’s guides.


    Biocompare

    Official Media Partner
    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.

    Media Partners


    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.


    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


    Technology Networks

    Supporters
    http://go.technologynetworks.com/subscribe-to-newsletters

    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


    IBI - International Biopharmaceutical Industry

    Supporters
    http://www.biopharmaceuticalmedia.com

    IBI - International Biopharmaceutical Industry, provides the biopharmaceutical industry with comprehensive coverage of key scientific, technology, regulatory and business topics. The editorial mix of peer-reviewed papers, practical advice on managing bioprocessing and technology, regulatory and business columns, and expert commentary provides comprehensive coverage of upstream and downstream processing, manufacturing operations, regulations, formulation, scale-up/technology transfer, drug delivery, analytical testing and more. The insight and analysis covers biologic – based therapies including We will report on emerging trends, strategies and best practices in the key areas.


    Hospital & Healthcare Management

    Supporters
    https://www.hhmglobal.com/media-pack



    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.


    BioChem Adda

    Supporters
    https://www.biochemadda.com/

    BioChem Adda is a Not-just-for-Profit organization which aims to bring out the most reliable and transparent information about everything related to jobs, careers, education, news, articles, and events from the field of BioSciences and Chemistry!


    pharmanews hq

    Supporters
    http://http://pharmanewshq.com

    MedChemNet provides a unique and unparalleled platform for the medicinal chemistry community to share insights, discuss the latest research, and help move the field forward. MedChemNet covers all aspects of the drug discovery pipeline, from target identification and validation, through computer aided drug design (CADD), synthesis, screening and other biophysical techniques, to development of novel lead compounds and pre-clinical in vivo proof of concept. We also cover the design of synthetic drug delivery carriers and ADME/toxicology studies, as well as intellectual property and economic related issues. Website: Welcome to Pharma News HQ, the journal dedicated to the pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry. Pharmanewshq.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production.


    Pharmaceutical-Review

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

    Pharmaceutical-review.com is part of Integrated IQ technologies Private Limited(IIQ). A Leading platform for all the Pharma manufacturing companies and buyers across the world.Having a subscriber database of more than 120,000 globally helping the clients to reach their target buyers through our exclusive listing, branding(banner advertisement), e-news letters, e-mail marketing, product reviews, product launch promotions, event marketing, search engine marketing and social media marketing services.


    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.


    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.


    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


    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.


    SelectScience

    Supporters
    http://www.selectscience.net/register?utm_source=Media-Partner&utm_medium=Website&utm_campaign=SMI

    SelectScience is an independent, online information resource for the worldwide scientific community, and the home of trusted information for laboratory scientists. Discover the latest drug discovery and development technologies, products and techniques with product reviews, videos, application notes and news articles. Become a member for free today.


    Pharma Journalist

    Supporters
    http://www.pharmajournalist.com

    Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry. Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry. Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.

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    Sheraton Boston Hotel

    39 Dalton Street
    Boston 02199
    USA

    Sheraton Boston Hotel

    Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

    Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
     

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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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    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
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