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The SAE Media Group is proud to announce the 2nd annual Aseptic Processing Conference
19th - 20th September, 2022 | London, UK
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The Aseptic processing industry has seen consistent growth in recent years -- with advances in innovative therapeutics, the introduction of novel techniques and personnel protocols, the integration of robotics and automation in filling lines, and rise of rapid microbiological methods being just a few of the factors driving this growth.

Aseptic Processing comes at the point in the manufacturing of pharmaceuticals where the product itself is at its highest value, and with such high investment comes many complex challenges to discuss, explore, and overcome -- ultimately via careful planning, thoroughly trained personnel, and specialised facilities and equipment.

Contamination control measures in GMP combine technical and organisational/ procedural control measures following Quality Risk management principles and when applied for processing specific sterile products or advanced therapies require to be defined in a Contamination control strategy; CCS (Annex 1 requirement).


 

This workshop considers technical control measures and their attributes including environmental controls, barrier technology and single use systems.
The workshop covers characterisation/ definitions of control measures and regulatory expectation to qualify contamination control
 

 

Validation Managers
Quality Control Managers
Quality Assurance Experts
Leaders in Sterility Assurance
Cleanroom Managers
Regulatory Affairs Managers
Production Managers
Quality Systems Managers
Senior Sterility Assurance Manager
Sterility Assurance Specialist
Sterile Manufacturing Manager
Senior Microbiologist
Sterile Manufacturing Specialist
Lead Scientist
Laboratory Manager
QA Specialist
Drug Substance External Manufacturer
QC Scientists
Heads of Quality Control
Business Development Manager
Pharmaceutical Microbiology Consultant
Higher Pharmacopoeial Scientist
Analytical Standards Specialist

 


 

Workshop LEADER

keynote-img

Richard Denk

Senior Consultant Aseptic Processing & Containment, SKAN AG

Richard Denk is working at the company SKAN AG, headquartered in Allschwil Switzerland in the position Senior Consultant Aseptic Processing & Containment. Richard is member of the PDA Isolator Expert Group, ISPE Sterile Product Processing Group, Chair of the ISPE Containment DACH, the ISPE SIG Robotic and Co-Chair ISPE SIG Bio on Innovations and Technology. Furthermore, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group.

SKAN AG

Previous attendee include

Abbott Laboratories; Advanced Sterilization Products (J&J); Ajinomoto Althea, Inc.; Allergan; Althea; Amneal Pharmaceuticals; Associates of Cape Cod; Association of Cape Cod, Inc; AstraZeneca; Atara Biotherapeutics; Battelle Memorial Institute; Bayer Healthcare; Bimeda; Biofiredx; Biomerieux; bioMerieux Industry; Bioscience International; BioVectra Inc; BioVigilant Systems; Charles River; Charles River Laboratories; Fujifilm Wako Chemicals USA Corp; Genentech; Genentech Inc; Genentech, Inc; Gilead Sciences; Grifols Biologicals; Janssen; Lonza Walkersville, Inc.; Mettler Toledo; Microbiologics; Microrite Inc.; Microrite, Inc.; Millipore Sigma; Morphotek, Inc.; Mycoplasma Biosafety Services GmbH; Northstar Medical Radioisotopes; Novatek International; QuVa Phama; Rapid Micro Biosystems; Regeneron Pharmaceuticals; Revance Therapeutics; Roche; San Diego State University, Women in Science Society; Steris Corporation; Takeda Pharmaceutical Company Limited; Teva Pharmaceuticals; UCSD; Ultragenyx Pharmaceutical; University of California San Diego; University of New England; University of Veterinary Medicine Vienna; Vital Therapies; Xellia Pharmaceuticals;
 

Workshop programme

8:30 Registration & Coffee

9:00 Opening remarks and introductions

9:10 What is new in the Annex 1

Richard Denk

Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
View Bio

• Journey to the released document
• What is important to consider
 

9:50 Contamination and Cross Contamination Control using Barriers

Richard Denk

Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
View Bio

• What are the differences on Barriers
• What is important to consider using Barriers
• How do design a Barrier to become Annex 1 Compliance
 

10:30 Morning Coffee

11:00 Cleaning and Surface Decontamination

Richard Denk

Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
View Bio

• How to clean to prevent contamination and cross contamination?
• How to design an QbD (Quality by Design)Surface Decontamination?
• How to deal with Stopper Bowls and sterilization?
 

11:40 New Technologies like Robotics

Richard Denk

Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
View Bio

• What is important to consider using robotics
• Where does Robotic make sense in Aseptic Processing
 

12:20 Closing remarks

Richard Denk

Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
View Bio

12:30 End of Workshop

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VENUE

Copthorne Tara Hotel

Scarsdale Place, Kensington, London, United Kingdom

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.

 

A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SAE Media Group. SAE Media Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
HOTEL BOOKING FORM

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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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Contact SAE Media Group

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
Website: http://www.smgconferences.com Email: events@saemediagroup.com
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