Communities of Practice

1
Communities of Practice

• Communities of Practice (CoP) are defined by
  Etienne Wenger as
• Groups of people who share a concern, a set of
  problems, or a passion about a topic, and who
  deepen their knowledge and expertise by
  interacting on an ongoing basis.

2
ISPEs Communities

• Active Pharmaceutical Ingredients (API)
• Biotechnology
• Clinical Materials Committee
• Commissioning and Qualification (C Q)
• GAMP Forum

• Process Analytical Technology (PAT)
• Process / Product Development (PPD)
• Project Management
• Sterile Products Processing (SPP)
• Water/Steam

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Types of participation
Occasional / Peripheral participants
Active participants
Core Group (Co-ordination)
A community is a living entity not unlike a
family
4
Core Group
One International Team

• Gail Boydston (Eli Lilly Co.)
• Donal Cronin (AstraZeneca)
• Phil Desantis (Schering Plough)
• Betsy Fritschel ( Johnson Johnson)
• Damian Greene (Chair) (Pfizer)

• Bill Jarvis (CRB)
• Scott Ludlum (ISPE)
• Stan Newberger (CE IC)
• John Nichols (Foster Wheeler)
• Simon Shelley (GSK)
• Julian Wilkins (Co-chair) (Pharmaconsult US Inc)
• Patrick Wong (BMS)

5
The Vision

• The API CoP will proactively advocate the
  importance of API in the drug product delivery
  process with the objectives of providing a forum
  for members to discuss issues of common interest
  through
• Education and training
• Discussion Forums
• Regulatory cooperation
• Information dissemination
• Establishment of links to internal and external
  groups with common interests

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Potential Interest

• The worldwide market for human dose API estimated
  to have been 54billion in 2003 and to grow to
  about 70billion in 2008.
• There are 600 API manufacturers licensed by FDA
  outside the USA
• There are nearly 23,000 members of ISPE
• PhRMA has nearly 70 member companies
• ABPI has just over 80 member companies
• APIC group of CEFIC have over 50 member companies

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Its All About Communication

• Website (our primary tool)
• Discussion Forums
• Meetings
• Conferences
• Newsletters
• Teleconferences
• Guides and standards

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Education and Training

• Provide input to educational themes working in
  close collaboration with the North American and
  European Education Committees
• Organise seminar sessions
• Provide speakers and organisers
• Develop curriculum for training
• Establish an API training module (future)
• Interface with Industry

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Guides and Standards

• Review forthcoming standards and guides, such as
  the revised ISPE BPC Baseline Guide
• Become involved in the development of standards,
  such as through collaboration with ASTM
• Determine what the industry needs and ensure its
  preparation

10
Newsletter

• The API CoP newsletter is a regular means of
  communication featuring
• Current activities the API CoP is engaged in
• Current topics of interest to the API community
• Opportunities to participate and become involved
• Industry updates
• Regulatory changes
• Forthcoming events, documents, etc.

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Website
www.ispe.org/api

• Three levels
• Access page to the CoP gives link to the API CoP
  site Open to all - introduction and basic
  information.
• Full community information on all CoPs - next
  level - access to all ISPE members provides
  resources
• Further area for routine administration of the
  core group

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Website
www.ispe.org/api

• Full community information includes
• Discussion forums / SIG re-aligned to the CoP
  areas
• (We need owners for each folder)
• Certain topics will be accessible from more than
  one CoP, such as those related to PAT
• News section
• Links to relevant seminars
• Links to relevant standards and guides
• Search engine for relevant API topics throughout
  ISPEs Body of Knowledge (articles, papers, etc.)
• Listing of recent publications
• Feedback function

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Opportunities for Involvement
U

• Participate in discussion forums
• Attend conference sessions and seminars on
  relevant API topics
• Feedback to the core group interest areas, needs,
  etc.
• Access to API CoP peers to obtain solutions to
  real-world problems
• Numerous online and personal networking
  activities

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API CoP Session During 2005 Annual Meeting

• Quality by Design the cGMP Quality System
  Approach
• An Introduction to the API Community of practice.
  Damian Greene, Pfizer
• Background and overview of the quality systems
  approach to Pharmaceutical current Good
  Manufacturing Practice regulations. Speaker
  from US FDA
• Risk-based approaches for cGMP manufacture of
  APIs. Dr Jeff Levy, Eli Lilly
• Process control strategies to prevent or mitigate
  risk in API manufacture, with a focus on use of
  PAT and SPC Joep Timmermans, Pfizer

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Your API CoP Needs You!