2018 PMF Fall Forum: Current Trends in Pharmaceutical Microbiology

We are very excited to announce this year's PMF Fall Forum, "Current Trends in Pharmaceutical Microbiology".  Leading industry experts will present and discuss topics relating to current regulatory, compendial and enforcement trends in Quality Control Microbiology.

Our industries, relying on compliance with current Good Manufacturing Practices, are subject to the ever-evolving continuum of our regulatory environment.  This conference will provide you with a perspective on several current trends relating to QC Microbiology.  We are privileged to have well-recognized industry Subject Matter Experts present their knowledge and experiences with tackling the challenges associated with these trends, ranging from QC Microbiology data integrity to historical and current regulatory enforcement actions relating to Burkholderia cepecia complex.  Effectively recognizing and addressing these current trends is key to cGMP compliance.

“Current Trends in Pharmaceutical Microbiology” will provide an excellent opportunity for participants to acquire the knowledge and learn the skills necessary for managing these challenges.

MAIN TOPICS

• Utilizing an Organized Data Driven Approach to Investigate, Solve Problems, and Demonstrate Process Control
• Establishing Environmental Monitoring Alert and Action Levels: A Novel Case Study
• Burkholderia cepacia complex: Current Regulatory Trends
• Manufacturing Quality Product in an Aging Facility
• Monitoring of Purified Water Systems
• QC Microbiology: How Automation and Integration Enforce Data Integrity
• Use of the USP for Training, Standards, and Best Practices in Pharmaceutical Microbiology
• Surviving the Microbiology Lab Audit - Tips from the Trenches
• Identification Techniques of Environmental Isolates

WHO SHOULD ATTEND

• Microbiology laboratory supervisors and microbiologists responsible for testing and release of Pharmaceutical, Biologic and Medical Device products
• 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 QC Microbiology GMP operations
• GMP trainers   

 

Early Registration Discount: Register by October 5th to receive $200 off the registration fee!

TRAVEL INFORMATION:

Nearest Airport:  PHL

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.

Schedule

Speakers

Robert Westney, Moderator 

Bob is the Founder and President of Cryologics Inc., Principal Consultant for Westney & Associates Consulting LLC, and a member of the Microbiology Network consortium of consultants.  He has more than 30 years of experience in the GMP industry, including Quality Control Microbiology, Quality Assurance and Regulatory Affairs.  He holds a Master of Science degree from Temple University in Quality Assurance / Regulatory Affairs.  He is Regulatory Affairs Certified (RAC) and is a Certified Manager of Quality and Organizational Excellence (CMQ / OE).  He is a member of the Pharmaceutical Microbiology Forum (PMF), the American Society for Microbiology (ASM), the Parenteral Drug Association (PDA), the Regulatory Affairs Professional Society (RAPS), and a Senior Member of the American Society for Quality (ASQ).

Matthew Paquette 

Matthew Paquette is a Product Specialist for Charles River.  He received his Bachelor of Science degree in microbiology from the University of Massachusetts Amherst and his Master of Business Administration degree in Six Sigma / Quality Management from Southern New Hampshire University. Matthew has over 10 years of experience in Quality Control Microbiology, Regulatory Compliance, Pharmaceutical Investigations, and Manufacturing Science. His other industry experience includes utilizing Six Sigma and DMAIC methodologies to drive to root cause of complex quality control and manufacturing problems, leading cross-functional investigation teams, leading method development and validation teams in the quality control microbiology laboratory space, and leading beta testing teams for new and complex laboratory instrumentation. 

Doug Schmidt  

Doug Schmidt is the Director of Quality Control for Exela Pharma Sciences overseeing QC Microbiology and QC Chemistry laboratory operations. He has worked in sterile pharmaceutical manufacturing for the past 10 years and in GMP pharmaceutical manufacturing for 15 years with QC Microbiology experience in both sterile and non-sterile processes. Doug holds a B.S. degree from Clemson University in Microbiology. He is a member of the Pharmaceutical Microbiology Forum (PMF), the American Society for Microbiology (ASM), and the Parenteral Drug Association (PDA).