ISPE Communities of Practice

CRB serves on ISPE's Communities of Practice (COP), which are forums that enable pharmaceutical science manufacturing professionals to interact and discuss emerging industry trends and find solutions to similar problems. COPs serve as the focal point for various committees and contribute to the production of new content and the ISPE Body of Knowledge.

Communities of Practice:

Active Pharmaceutical Ingredients (API)

The API COP proactively advocates 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; Listserv E-Discussions; regulatory cooperation; information dissemination; establishment of links to internal and external groups with common interests.
CRB: Bill Jarvis, Christa Myers


The Containment COP provides a forum for all those involved in the Safety of Patients and People from exposure, contamination and cross contamination of hazardous compounds and interact with all appropriate stakeholders to share, influence and change knowledge, guidance and regulation for the good of all.
CRB: Bill Jarvis

Process/Product Development (PPD)

The PPD COP is a dynamic forum for professionals in product/process development to discuss and address issues of common interest.
CRB: Eric Unrau

Operations Management

The Operations Management COP aims to cover and review all areas of operations management including the integrated process flow from the supply of raw materials to final product distribution. The goal is to discuss and better understand how a complex pharmaceutical manufacturing plant can work more efficiently to increase productivity.
CRB: Niranjan Kulkarni, PhD

ISPE Members:

CRB is proud of the involvement of its employees in ISPE. Currently, we have 183 professionals who are registered members of ISPE.

ISPE Instructor - Mark von Stwolinski

North American Sterile Facility Course European BioPharm Facility Course

Current ISPE National Participation:

Jeff Biskup, Board Member
Mark von Stwolinski, Guidance Document Executive Committee
Niranjan Kulkarni, Steering Committee Member, Operations Management
Shannah Schodle Falcone , North America/South America Affiliate Council, Chair; Drug Shortages Committee, Communications Team; Facility of the Year Committee; Annual Meeting, Marketing Advisor; New Content Advisory Group

Current Regional ISPE Board Participation:

Lisa Kerner, President, Southeast Chapter
Jeff Rozelle, Vice President, Midwest Chapter
Lindsay Kenney, President, Rocky Mountain Chapter
Howard Sneider, Program Committee Co-Chair, Boston Chapter
Brian Vaughn, Board Member, San Francisco Bay Area Chapter
Trevor Auer, Board of Directors, San Francisco Bay Area Chapter


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