When
Thursday, October 31, 2019 at 8:00 AM EDT-to-
Friday, November 1, 2019 at 3:30 PM EDT
Add to Calendar
Where
DoubleTree by Hilton Hotel-Philadelphia Center City
237 S. Broad Street
Philadelphia, PA 19107
Reservations may be made either online at https://book.passkey.com/e/49981853 or by calling the Doubletree reservation line at 800-222-8733.
This conference has been confirmed.
Nearest Airport: PHL
Contact
Mary Ellen SuttonThe Microbiology Network/Pharmaceutical Microbiology Forum
585-210-8336
conference@microbiologynetwork.com
2019 PMF Fall Forum: Current Trends in Nonsterile and Aseptic Manufacturing
While nonsterile and aseptic manufacturing are regarded as two distinctly different sectors of our industry, many aspects of QC Microbiology are relevant to both. Burkholderia cepacia complex challenges, disinfectant efficacy testing, contamination prevention, and proper laboratory training are just a few areas that bridge these sectors. Effectively understanding these central principles, including regulatory expectations and implementing systems to support them, is the key to success.
“Current Trends in Nonsterile and Aseptic Manufacturing” will provide an excellent opportunity for participants to acquire the knowledge and learn the skills necessary for meeting these challenges.
MAIN TOPICS
-
Current FDA Microbiology Inspection Trends: Nonsterile and Sterile Products Manufacturing and Testing Facilities
-
Control of Burkholderia Cepacia Complex in Water Systems
-
Fundamentals of Disinfectant Efficacy Testing
-
USP <60> and Excluding Burkholderia Cepacia Complex from Aqueous Nonsterile Drug Products
-
Testing of Purified Water, Raw Materials, In-Process Samples and Finished Non-Sterile Product
-
Objectionable Organism Risk Assessments
-
Auditing Sanitary Design of Non-Sterile Product Manufacturing
-
Training on the Right Things in the Microbiology Laboratory
WHO SHOULD ATTEND
Microbiology laboratory supervisors and microbiologists responsible for testing and release of Pharmaceutical, Biologic, Medical Device, Dietary Supplement and Cosmetic 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
WHO SHOULD ATTEND
Microbiology laboratory supervisors and microbiologists responsible for testing and release of Pharmaceutical, Biologic, Medical Device, Dietary Supplement and Cosmetic 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
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.
Speakers
Robert Westney, Moderator
Director of Quality and Operations, Cryologics, Inc.; Principal Consultant, Westney & Associates Consulting, LLC
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).
David Jaworski 
Tentative Presentation Title: Current FDA Microbiology Inspection Trends: Nonsterile Products Manufacturing and Testing Facilities
David has broad experience in all aspects of drug product manufacturing. He has direct experience with biotech and small molecule manufacturing, operation of plants, large project management, and P & L management. David is interested in Protecting the Public Health by application of High Quality manufacturing processes and effective Quality Management. David received his Masters of Business Administration degree from Syracuse University in 1985, and Bachelor of Science Degree in Microbiology from Penn State University in 1973.
Tony Cundell, Ph.D.
Presentation Title: USP <60> Microbiological Examination of Nonsterile Products: Tests for Burkholderia Cepacia Complex
Dr. Cundell consults with a number of pharmaceutical, consumer health and dietary supplement companies, microbiology instrument manufacturers, contract testing laboratories and sterile compounding pharmacies in the areas of microbial risk assessment, regulatory affairs, and microbiological testing. Prior to November 2013 he held high-level positions at Merck Research Laboratories, New York Blood Center, Lederle Laboratories, Wyeth Pharmaceuticals and Schering-Plough. Tony is a member of the 2015-2020 USP Microbiology Committee of Experts. He is very involved with the Parenteral Drug Association, having played key roles in developing PDA Technical Reports No. 33 and 67. He has authored numerous book chapters and industry publications. More recently Dr. Cundell co-authored a review article entitled “Data Integrity in the Microbial Testing” in the September-October 2017 issue of American Pharmaceutical Review.
Rick Jakober
Vice President, Laboratory Services, Perritt Laboratories, Inc.
Presentation Title: Objectionable Organism Risk Assessments
Rick is a seasoned researcher with wide ranging experience in microbiological analyses including in-depth knowledge of FDA and compendial cGMP requirements combined with broad knowledge and experience in USP, Ph. Eur., JP, ISO, ASTM, EPA, and AOAC methodologies. In addition, he has over 35 years of experience in pharmaceutical microbiology, specializing in non-sterile products. This includes Microbial Content testing, Antimicrobial Effectiveness Testing, Purified Water Systems, Environmental Monitoring, Mycology and inorganic chemical analyses. Rick has been with Perritt Laboratories since 1987 and previously was with Carter-Wallace and Ayerst Laboratories. Rick earned a B.S. in Environmental Sciences at Cook College, Rutgers University.
Dilip Ashtekar, Ph.D.
Chief Consultant, RCMS Consulting Services, LLC 
Presentation Title: Pharmaceutical Grade Purified Water System: Burkholderia cepacia complex (BCC) Contamination Remediation and Control
Dr. Ashtekar is a results-oriented collaborative and industry recognized expert leader in microbiology and sterile product manufacturing, with over 30 years of a successful and proven record of increasing responsibilities in leading pharmaceutical small molecule, biotechnology (monoclonal antibodies), biologically-derived protein therapeutics, cell therapy, plasma fractionation and plasma-based products, and vaccine industries. He is a member of the United States Pharmacopeia (USP) Expert Microbiology Committee (2010-Current). In addition, he serves as one of the key experts of several Parenteral Drug Association (PDA) taskforces and has co-authored several Technical Reports, including Technical Report No. 13, “Fundamentals of an Environmental Monitoring Program”, and Technical Report No. 33, “Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods”
Crystal Booth, M.M. 
Regional Manager, PSC Biotech Corporation
Presentation Title: Fundamentals of Disinfectant Efficacy Testing
Crystal M. Booth, M.M., is a Regional Manager at PSC Biotech and has over 20 years of experience in pharmaceutical microbiology, environmental monitoring, and Quality Assurance. She obtained her master’s degree in microbiology from North Carolina State University. Crystal is a seasoned award-winning technical writer and author of the PDA 2017 book, “Method Development and Validation for the Pharmaceutical Microbiologist”. During her career, Crystal has worked in microbiology, consulting, Quality Assurance, CDMOs, R&D, and Quality Control laboratories. Crystal has developed and validated numerous microbiological methods and has worked with many different product types.
Andrew Dick
Senior Manager Quality Assurance Tech Services, Johnson & Johnson
Presentation Title: Contamination Prevention in Nonsterile Pharmaceutical and Cosmetic Manufacturing
Andrew has a combined 25 years of experience within medical microbiology, food microbiology and pharmaceutical microbiology, including Quality management of manufacturing sites and laboratories. He is a member of the PDA, PCPC and PMF. He has recently written a book, “Contamination Prevention for Nonsterile Pharmaceutical Manufacturing”, published by the PDA in 2018. He has co-authored a technical report with the PDA, TR No. 67, “Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices and Cosmetics”. He has a BS in Medical Technology from Kean University and a MS in Microbiology from Wagner College.
Tony Luttrell 
President and Co-Managing Member, Luttrell Consulting Group (retired)
Presentation Title: Training on the Right Things in the Microbiology Laboratory
Tony Luttrell has forty years of experience in the pharmaceutical, biopharmaceutical, and medical device industries. He specializes in operations management and quality systems for active pharmaceutical ingredients, finished pharmaceuticals, medical devices, and biological products including vaccines, recombinant products and cell therapy. He has extensive experience in all aspects of development, manufacturing and Quality Assurance in a GXP environment. Mr. Luttrell has held numerous positions of increasing responsibility in industry, from the laboratory bench to executive management. He has been responsible for several successful operational turnarounds and specializes in helping operations mature and build scalable systems and organizations.
Randy Hutt 
Head of Sterility Assurance
Presentation Title: Testing of Purified Water, Raw Materials, In-Process Samples and Finished Non-Sterile Product
Dr. Randy Hutt has 40 years of experience in the Pharmaceutical and Biological industries, management in pharmaceutical companies such as American Regent, Inc. (formerly called Luitpold Pharmaceuticals, Inc.), Wyeth-Lederle, Burroughs Wellcome, and Schering Plough. Currently, Dr. Hutt is Head of Sterility Assurance (SA), which provides an oversight function for assurance of aseptic conditions and microbial control. Previously, Dr. Hutt was Associate Director of Sterility Assurance and Microbiology, which included the laboratory and environmental monitoring at Luitpold, and has over 20 years of QA/QC experience including that at other companies. In addition, she has 10 years of aseptic production management experience and several years of consulting, both in the US and internationally, performing pharmaceutical microbiological Investigations, cGMP audits, and training on how to perform audits. She has given presentations on Microbial Investigations to the Parenteral Drug Association (PDA), the Pharmaceutical Microbiology Forum (PMF) and the Institute of Validation Technology (IVT). Her Ph.D. is in Microbiology, specializing in viruses, particularly Herpes viruses, from the Hershey Medical Center (part of Penn. State University).