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EU GMP Annex 1 differentiates Environmental classification, Qualification and risk based (holistic) monitoring of GMP controlled areas that are used in the manufacture of sterile medicines. ISO 14644-1 is generic for Cleanroom classifications and it is not always clear how to apply considering a risk based GMP approach. Qualification extends through establishing environmental control through process simulations and media fills with strategies required or how to qualify Cleanrooms and Barrier technology (Isolators & RABS). EM programs require a holistic approach considering risk based/ risk assessed sampling locations that are connected through all stages of classification, qualification and monitoring. This workshop explain the relationship and methodology for Classification, Qualification and Environmental monitoring.

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.

Classification of GMP controlled areas with a focus on 0.5micron particle sizes is a GMP requirement and referenced in Annex 1 but it is not always clear on how ISO14644-1 is applied. Qualification combines particle sizes of 0.5 and 5.0 micron plus not to exceed microbiological levels (surface and airborne) and requires rationale. Consideration provided to the PHSS rationale (reviewed by the MHRA). Environmental monitoring data is critical to sterile product release as evidence sterile products have not been contaminated from the processing environment. Current best practice is explained including rationales for monitoring environments that may contain toxic or biologically active sterile products or therapies.

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Workshop programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

James Drinkwater

James Drinkwater, Chairman of PHSS and Head of GMP Compliance F Ziel GmbH, Franz Ziel Gmbh
View Bio

9:10 Environmental Classification of GMP controlled areas

James Drinkwater

James Drinkwater, Chairman of PHSS and Head of GMP Compliance F Ziel GmbH, Franz Ziel Gmbh
View Bio

• ISO14644-1 application in GMP cleanroom classification
• Classification sampling positions – risk based
• Classification of Cleanrooms and Barrier GMP Zones – why different approaches are required.

9:50 Environmental Qualification

James Drinkwater

James Drinkwater, Chairman of PHSS and Head of GMP Compliance F Ziel GmbH, Franz Ziel Gmbh
View Bio

• GMP Compliance environmental qualification considering 1m3 sample volumes.
• Environmental qualification start-up to state of control including microflora characterisation, operational monitoring.
• Environmental qualification through process simulations and Media Fills.

10:30 Morning Coffee

11:00 Risk based environmental monitoring methods, program and data trending

James Drinkwater

James Drinkwater, Chairman of PHSS and Head of GMP Compliance F Ziel GmbH, Franz Ziel Gmbh
View Bio

• EM risk assessments for sample locations and sample type
• EM programs: management, structure and data processing
• Perspective on use of Rapid Micro Methods: RMM

11:40 Case study: Environmental Classification, Qualification and Risk based monitoring of a vial/syringe Filling line and relationship with Contamination Control Strategy: CCS for EU GMP Annex 1 compliance.

James Drinkwater

James Drinkwater, Chairman of PHSS and Head of GMP Compliance F Ziel GmbH, Franz Ziel Gmbh
View Bio

• Overview of Case study: Biological product Vial/Syringe Filling Line in Isolator Barrier technology with use of pre-sterilised containers transferred to Grade A aseptic processing zone via NTT: No-touch-transfer technology.
• Overview of Rationale for Environmental Classification, Qualification and Monitoring for the Aseptic processing filling zones and surrounding Cleanroom.
• Application of QRM: Quality Risk Management applied where application varies from conventional/ generic GMP

12:20 Closing remarks

12:30 End of Workshop

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FEATURED SPEAKERS

James Drinkwater

James Drinkwater

Chairman of PHSS and Head of GMP Compliance F Ziel GmbH, Franz Ziel Gmbh

James Drinkwater

Chairman of PHSS and Head of GMP Compliance F Ziel GmbH, Franz Ziel Gmbh
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.
 

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.
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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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