When
Thursday, October 5, 2017 at 8:00 AM EDT-to-
Friday, October 6, 2017 at 3:00 PM EDT
Add to Calendar
Where
Baltimore Marriott Waterfront Hotel
700 Aliceanna St.
Baltimore, MD 21202
This conference has been confirmed.
Contact
Mary Ellen SuttonThe Microbiology Network/Pharmaceutical Microbiology Forum
585-210-8336
conference@microbiologynetwork.com
2017 PMF Fall Forum Non-Sterile Manufacturing Challenges
We are very excited to announce this year's PMF Fall Forum, "Non-Sterile Manufacturing Challenges". Leading experts with experience in both industry and FDA will present many key aspects of Non-Sterile Manufacturing, 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
- Qualifying an Environmental Monitoring Program for Non-Sterile Manufacturing: A Case Study
- Training on the Right Things in the Microbiology Laboratory
- Raw Materials Quality - You and Your Supplier Have Significant Impact
- Objectionable Microorganisms in Purified Water: Current Regulatory Expectations
- Contamination Prevention in Nonsterile Manufacturing of Pharmaceutical Drugs, Cosmetics and Medical Devices
- Considerations for Disinfection of Non-Sterile Manufacturing Facilities
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.
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
- Qualifying an Environmental Monitoring Program for Non-Sterile Manufacturing: A Case Study
- Training on the Right Things in the Microbiology Laboratory
- Raw Materials Quality - You and Your Supplier Have Significant Impact
- Objectionable Microorganisms in Purified Water: Current Regulatory Expectations
- Contamination Prevention in Nonsterile Manufacturing of Pharmaceutical Drugs, Cosmetics and Medical Devices
- Considerations for Disinfection of Non-Sterile Manufacturing Facilities
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.
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.