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The aseptic processing industry has seen many changes during its progression towards the 21st century. With advances in innovative therapeutic manufacturing such as ATMPs, pragmatic barrier system applications, adaptability and modularity in fill finish, robotics and automation, small and agile product manufacturing, just to name a few. In 2018, the global aseptic processing market was valued over $56 trillion and is estimated to increase in net revenue upwards $124 trillion by 2027, with a CAGR growth of 9.18%.

The industry is ever changing and with the advent of innovative therapeutics taking hold, regulators and industry leaders are prompted to take proactive approaches to get treatments to patients faster. Join us this year to explore novel and developing technologies that tackle the most pressing challenges and push innovation in the world of aseptic processing and sterile manufacturing.

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).

• Review the technical control measures and their attributes in
depth
• Exercise the characterisation of control measures
• Define regulatory expectations to qualify contamination control
• Discuss environmental controls, barrier technology and single
use systems

Allergy Therapeutics Ltd; AllergyTherapeutics; Associates of Cape Cod; Associates Of Cape Cod International; AstraZeneca; AstraZeneca PLC; Baxter; Baxter Healthcare Ltd; Bausch Strobel; BioMérieux; bioMerieux UK Limited; BioPhorum; Boehringer Ingelheim; Boehringer Ingelheim Pharma GmbH & Co. KG; Charles River EMD; Copan; Copan Group; Copan Italia SpA; CTL - MAT; European Patent Office; ExMoor; FDA; Food and Drug Administration; Fagron; Freeline; Fresenius Kabi; Fresenius Kabi UK Ltd; Groninger; GSK; GSK Vaccines; GW Pharma ; ; Kite Pharma ; Lonza; MeiraGTx; Meriagtx; Mettler Toledo; Mettler Toledo Ltd; Mettler-Toledo Ltd; Mettler-Toledo Thornton; MHRA; MIcrobiologics; Microgenetics Ltd; Novo Nordisk; Optima; Oxford Biomedica Ltd; Paul Ehrlich Institut; PHSS: Pharmaceutical & Healthcare Sciences Society; Reading Scientific Services Ltd; Reading Scientific Services Ltd (RSSL); Regeneron Pharmaceuticals Inc.; RSSL; Sanofi-Aventis Deutschland GmbH; SDA Pharma; SKAN; Steris Corporation; Techniconsult Firenze SRL; University of Veterinary Medicine Vienna; VCCN/Brookhuis Applied Data Intelligence; Veltek Associates, Inc.; Watson Marlow;

Workshop programme

8:30 Registration & Coffee

9:00 Opening remarks and introductions

James Drinkwater

James Drinkwater, PHSS Head of Aseptic Processing and Containment Special Interest Group & F Ziel GmbH Head of GMP Compliance, PHSS: Pharmaceutical & Healthcare Sciences Society
View Bio

Kevin Jenkins

Kevin Jenkins, Consultant, Quality Excellence Consulting LLC
View Bio

9:10 Part 1. Contamination control attributes and requirements in sterile product Aseptic processing

• Filtration and Air handling systems with zonation of classified areas for environmental control
• Pressure differentials bubble, sink and cascades and when to apply

James Drinkwater

James Drinkwater, PHSS Head of Aseptic Processing and Containment Special Interest Group & F Ziel GmbH Head of GMP Compliance, PHSS: Pharmaceutical & Healthcare Sciences Society
View Bio

Kevin Jenkins

Kevin Jenkins, Consultant, Quality Excellence Consulting LLC
View Bio

10:30 Morning Coffee

11:00 Airflow protection and cleanliness: Uni Directional airflow, Localised Uni-directional airflow and Grade A Air supply – Definitions and when to apply

• Cleaning, disinfection and VHP (Vaporised hydrogen peroxide) bio-decontamination – relationship with sterilisation in sterile product aseptic processing and regulatory expectations

James Drinkwater

James Drinkwater, PHSS Head of Aseptic Processing and Containment Special Interest Group & F Ziel GmbH Head of GMP Compliance, PHSS: Pharmaceutical & Healthcare Sciences Society
View Bio

Kevin Jenkins

Kevin Jenkins, Consultant, Quality Excellence Consulting LLC
View Bio

12:20 Closing remarks before workshop lunch break

James Drinkwater

James Drinkwater, PHSS Head of Aseptic Processing and Containment Special Interest Group & F Ziel GmbH Head of GMP Compliance, PHSS: Pharmaceutical & Healthcare Sciences Society
View Bio

Kevin Jenkins

Kevin Jenkins, Consultant, Quality Excellence Consulting LLC
View Bio

13:20 Registration & Coffee

13:50 Opening remarks and introductions

James Drinkwater

James Drinkwater, PHSS Head of Aseptic Processing and Containment Special Interest Group & F Ziel GmbH Head of GMP Compliance, PHSS: Pharmaceutical & Healthcare Sciences Society
View Bio

Kevin Jenkins

Kevin Jenkins, Consultant, Quality Excellence Consulting LLC
View Bio

14:00 Part 2. Case studies and contamination control strategies

• Case studies in preparation of a Contamination control strategy (CCS) and alignment with an Aseptic containment strategy when toxic, bio-hazard and cross contamination control are required
• Relationships of risk assessments in assessing risks of contamination with risk mitigations by controls (process risk assessment) and detectability of contamination events and trend deviations via environmental monitoring

James Drinkwater

James Drinkwater, PHSS Head of Aseptic Processing and Containment Special Interest Group & F Ziel GmbH Head of GMP Compliance, PHSS: Pharmaceutical & Healthcare Sciences Society
View Bio

Kevin Jenkins

Kevin Jenkins, Consultant, Quality Excellence Consulting LLC
View Bio

15:20 Afternoon Tea Break

16:00 Reference guidance will be used to support the case studies presented where contamination control is required and provide a resource of continued reference after the workshop

James Drinkwater

James Drinkwater, PHSS Head of Aseptic Processing and Containment Special Interest Group & F Ziel GmbH Head of GMP Compliance, PHSS: Pharmaceutical & Healthcare Sciences Society
View Bio

Kevin Jenkins

Kevin Jenkins, Consultant, Quality Excellence Consulting LLC
View Bio

16:40 Closing remarks

James Drinkwater

James Drinkwater, PHSS Head of Aseptic Processing and Containment Special Interest Group & F Ziel GmbH Head of GMP Compliance, PHSS: Pharmaceutical & Healthcare Sciences Society
View Bio

Kevin Jenkins

Kevin Jenkins, Consultant, Quality Excellence Consulting LLC
View Bio

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FEATURED SPEAKERS

James Drinkwater

James Drinkwater

PHSS Head of Aseptic Processing and Containment Special Interest Group & F Ziel GmbH Head of GMP Compliance, PHSS: Pharmaceutical & Healthcare Sciences Society
Kevin Jenkins

Kevin Jenkins

Consultant, Quality Excellence Consulting LLC

James Drinkwater

PHSS Head of Aseptic Processing and Containment Special Interest Group & F Ziel GmbH Head of GMP Compliance, PHSS: Pharmaceutical & Healthcare Sciences Society
James Drinkwater

James L. Drinkwater
Head of GMP Compliance and Aseptic process support at F Ziel GmbH.
PHSS Head of Aseptic processing and Containment Special interest group and Annex 1 Focus group.
Together with the role at F Ziel James is the elected Head of the Not-for-Profit PHSS: Pharmaceutical & Healthcare Sciences Society Aseptic processing and Containment special interest groups. James is a Pharmaceutical process engineer with additional education in Pharmaceutical microbiology. Working experience includes 10 years in radio pharmaceutical manufacturing and over 20 years working in sterile product manufacturing support where increasingly aseptic processing applies. James is a Subject matter expert in Barrier Technology (Isolators and RABS) and Bio-decontamination with Hydrogen peroxide vapour (H202-VHP). James is also a Member of ISPE and Pharmaceutical Quality Group UK (PQG).
 

Kevin Jenkins

Consultant, Quality Excellence Consulting LLC
Kevin Jenkins

Kevin joined Pfizer through the Upjohn Company in 1983 as a Research Chemist in Kalamazoo, MI. He held positions of increasing responsibility in aseptic operations and, in 1996, was named Laboratory Supervisor. In 1998, Kevin accepted an international assignment as the Corporate Compliance Professional in Halden, Norway, where he prepared the IV bag facility for the first FDA Pre-Approval Inspection.

Kevin returned to Kalamazoo in 1999 as the Director Validation/Compliance. In 2003, he moved to Terre Haute, IN, and was appointed Director Quality Operations. Kevin transitioned into a technical services position in 2007, leading product development for aseptic and inhalation products. Kevin moved to Lincoln, NE in 2008, and was appointed Director, leading the site Lean Manufacturing, Continuous Improvement and Six Sigma programs. In 2009, he was appointed Director, Quality Operations, responsible for Vaccine/Biologics Animal Health Quality. Kevin returned to Kalamazoo in 2010, as Director, Quality Operations for the site. Between 2012 - 2018, he held senior quality leadership positions: Vice President, Global Quality; VP, Global Aseptic Quality; and VP Quality Excellence. In 2018, Kevin was appointed VP Sterile Injectables Quality with responsibility for twelve plants worldwide.

Kevin retired from Pfizer October 2019 after 36 years. He is currently a consultant with Quality Excellence Consulting LLC.

 

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 SMi Group. SMi 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, SMI 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@smi-online.co.uk

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