2016 PMF Fall Forum - GMP in the Pharmaceutical Microbiology Laboratory 

We are very excited to announce this year's PMF Fall Forum, "GMP in the Microbiology Laboratory".  Leading experts with experience in both industry and FDA will present many key aspects of GMP Microbiology, ranging from laboratory auditing to Environmental Monitoring.

 

Good Manufacturing Practices (GMPs) remain a prominent area of regulatory scrutiny of the QC Microbiology Laboratory.  Contract laboratories also bear the additional scrutiny of their customers.  In addition, the QC Microbiology Laboratory is a crucial supporter of an effective Environmental Monitoring program.

Effectively integrating the key aspects of QC Microbiology Laboratory operations can be challenging, given its broad role in supporting Quality Assurance, Regulatory Affairs, Facilities Engineering and Manufacturing.  The QC Microbiology Laboratory’s challenges also frequently include misunderstanding (or lack of understanding) of regulatory expectations, as well as limited resources, both in personnel and technical skills.

“GMP in the Pharmaceutical Microbiology Laboratory” will provide an excellent opportunity for participants to learn the skills necessary for managing many of these challenges.

MAIN TOPICS

• Auditing a GMP Microbiology Laboratory
• Surviving a GMP Microbiology Laboratory Audit
• A Sensible Approach to Environmental Monitoring
• Cleanroom Gowning
• Investigating EM Excursions
• The Role of In-House Microbial Isolates
• USP Chapters and Data Interpretation

WHO SHOULD ATTEND

• Microbiology laboratory supervisors and microbiologists responsible for testing and release of Pharmaceutical, Biologic and Medical Device products
• Environmental monitoring supervisors and personnel
• Regulatory and Quality compliance personnel responsible for auditing and ensuring GMP compliance of manufacturing facilities and microbiology laboratories, including contract manufacturers and laboratories
• Manufacturing, Engineering and Validation personnel responsible for contributing to microbiology laboratory and EM GMP operations
• GMP trainers   

Read more about the tentative agenda, speakers, and topics here.

 

TRAVEL INFORMATION

• This conference has been confirmed.
• Nearest Airport: Rochester, NY (ROC)
• Room reservations at the Woodcliff Hotel & Spa may be made by calling 800-365-3065.  Please reference the PMF Fall Forum to obtain the group rate of $139/night.  This rate expires 9/20/16.  We recommend you make your room reservations as soon as possible as there are a limited number of rooms available. 
• Complimentary Woodcliff Hotel Shuttle Information - Pre-arranged, complimentary van transportation is available to and from the airport, bus and train stations between the hours of 6:00 a.m. and 11:00 p.m. Monday-Friday.  Advance reservations are required.  Hotel shuttles take guests to the airport at the top of the hour (1 pm, 2 pm, etc.) and picks up from the airport at the bottom of the hour (1:30 pm, 2:30 pm, etc.)  Phone: 800-365-3065

Register Now! 

Cancellation Policy: PMF and Microbiology Network reserve the right to modify or cancel any event.  In the event of a cancellation, registrants will be notified as soon as possible and all registration fees will be reimbursed.  PMF and Microbiology Network are not responsibile for lost airfare due to cancellations.  Refund requests received at least 14 days prior to the date of the event will receive a full refund, less a $200 processing fee.  After that, no refunds will be issued.You may enroll a substitute at any time before the conference begins.