2008 PMF Conference on GMP in Microbiology
April 7-8, 2008
Gaylord Resort and Convention Center
DFW Metroplex, TX
Presented by the Pharmaceutical Microbiology Forum
Space still available.
Registrations will be taken until Friday, April 4th.
Guest rooms at
Gaylord Texan are still available
at the group rate ($199) by
calling High Peaks Associates (585-594-3336).
This conference is your opportunity to interact with
regulators and thought leaders in frank and open discussion on
issues of immediate relevance to the manufacturing environment.
Day 1 includes a 90 minute video conference providing the
opportunity to ask questions of FDA CDER Inspectors.
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Conference Description
The purpose of this meeting is to provide a forum for the
sharing of questions, answers and information on current topics
in GMP for the Microbiology Laboratory. Several recent guidance
documents have been issued that stress the role of the QC
microbiology laboratory in the successful manufacture of
finished product from both the FDA (Aseptic Processing Guidance)
and USP (draft <1117> Microbiology Lab Practices). The program
will range from presentations on technical and
compliance-related problems to interactive case studies to
round-table discussions.
This is an excellent opportunity to meet GMP training
requirements for both new hires and for those responsible for
training GMP to microbiology and manufacturing personnel.
Download the conference
brochure.
Topic List
- Overview of GMPs and their history
- Regulatory Basis of Microbiological
Testing
- Quality Systems for the Microbiology Lab
- FMEA and Microbiology Investigations
- USP Perspectives
- Lab Design
- Technology Transfer
- Recent Product Recalls with Microbiological basis
Speakers
- Lucia Clontz, DiosynthRTP, Inc
- Luis Jimenez, Immunomedics Inc
- Karen McCullough, MMI Associates
- David Porter, Ph.D. Vectech, USP COE*
- Donald Singer, GSK, USP COE, ASQ
- Scott Sutton, Ph.D., Vectech, USP COE
- FDA CDER/ORA Panel
*USP COE - USP Committee of Experts on Microbiology and
Sterility Assurance
Learning Objectives
Conference attendees will be able to:
- Understand the GMPs for pharmaceuticals and biologics
that are relevant to the microbiology function
- Understand and be able to implement an integrated
microbiology function taking prevention, preparation and
investigation all in their proper place
- Understand the importance of complete and through
microbial reports for regulatory inspections
purposes
- Understand how to participate in FMEA
Who Should Attend
- Microbiology Laboratory supervisors and Microbiologists
responsible for testing and release of Pharmaceutical,
Parenteral and Medical Device products.
- Regulatory and
Compliance Personnel responsible for auditing of manufacturing
facilities and QA and Contract Microbiology Laboratories.
- GMP Trainers
Book
Quality Control Systems for the
Microbiology Laboratory: The Key to Successful Inspections
by Lucia Clontz will be provided to each participant - a $200
value!. Meet the author at this conference!
Conference Facilitator:
Scott Sutton,
Vectech Pharmaceutical Consultants
Workshop Organizers
• The Pharmaceutical Microbiology Forum
•
High Peaks Associates (meeting coordinators)
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