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Robert Westney, M.S., RAC, CMQ/OE; Conference 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 30 years of experience in the GMP industry, including Quality Control Microbiology, Quality Assurance and Regulatory Affairs. He has worked for biotechnology and pharmaceutical manufacturers, as well as for pharmaceutical, biotechnology, cosmetic, and food contract testing laboratories. He has played key roles in numerous U.S. and international regulatory inspections. 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 / 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).
Presentation Title: “Qualifying an Environmental Monitoring Program for Non-Sterile Manufacturing: A Case Study”
This presentation will review a real-life case study describing the qualification of an environmental monitoring (EM) program for a non-sterile manufacturing facility. It will review the specific risk-based strategies for site selection and sample types, encompassing formulation, forming and filling of a non-sterile OTC solid oral dosage form. These strategies are applicable to a broad array of non-sterile manufacturing settings, including raw materials, active pharmaceutical ingredients, topical pharmaceuticals, and solid and liquid oral dosage forms. It will conclude with guidance on data analysis for the purpose of selecting sites to include in the routine EM program and establishing EM Alert and Action Levels.
Frank has over 30 years of pharmaceutical manufacturing and business experience, and is an authority on cGMP compliance, deviations and investigations, root cause analysis, rectification of sterile and non-sterile microbiological data deviations, particulate matter, and outsourcing of suppliers, contract laboratories and manufacturing sites. He is particularly adept at writing responses to 483s and warning letters that result in both interim controls and sustained cGMP compliance. He is the principal of Veracorp LLC, whose clients include virtual start-ups, compounding pharmacies, API manufacturers, solid and liquid oral dosage manufacturers, sterile facilities, medical device operations and microbiology laboratories. Veracorp LLC assembles teams of multidisciplinary experts and often leads its client’s Quality System remediation initiatives.
PresentationTitle: “Objectionable Microorganisms in Purified Water: Current Regulatory Expectations”
This presentation will cover the following areas:
• What is Purified Water?
• When should it be used?
• What are the regulatory requirements for Purified Water?
• Recent FDA observations related to Purified Water
• What microorganisms are objectionable to Purified Water systems?
• Conducting a risk assessment if an objectionable microorganism is found in Purified Water
• Conducting an investigation if an objectionable microorganism is found in Purified Water
• Corrective Actions to eliminate objectionable microorganisms from Purified Water systems
Don is a GSK Senior Fellow, an American Society for Quality Fellow and Manager, Biopharmaceutical GMP Ops at GSK. Don has been a member of the USP Microbiology Committee of Experts since 2000, and is currently Vice-Chair of the committee. He is a Certified Specialist Microbiologist (NRCM) and Certified Pharmaceutical GMP Professional (ASQ), and has been a Malcolm Baldrige National Quality Award Examiner. Don’s career spans over 35 years of research, Quality Control, and Quality Assurance experience in the pharmaceutical, cosmetic, and food industries. He is an author and a globally invited instructor for microbiological control and quality programs. Don is currently an adjunct instructor in the Biopharmaceutical Quality program at University of Maryland Baltimore County.
Presentation Title:“Raw Materials Quality - You and Your Supplier Have Significant Impact”
Depending on the size of the facility and the number and classification of rooms or zones, environmental monitoring (EM) typically requires a significant outlay of resources. All too often, the mountains of data collected provide little practical information, or is seriously overwhelming to deal with and is often ignored to a large extent; trending is delayed or omitted in the crunch of many other priorities. The setting of meaningful control levels is problematic and may result in unnecessary and excessive excursions and investigations. This presentation will focus on what the EM program is designed to reveal, how to select meaningful sample sites, and when and how to assess the EM program for a possible reduction in sample sites. In addition, this presentation will include a discussion on how to manage the microbial isolates recovered from the EM program, including what is significant and/or objectionable, when to retain the isolates and for what purpose.
Awareness of the parameters that should be controlled for microbiological quality of raw materials used in the manufacture of non-sterile and sterile products is a shared relationship. Customer and supplier have responsibilities for the materials used in manufacturing of products. Engaging a supplier will enhance the development of improved understanding of the microbiological quality risks and aspects of excipients and active pharmaceutical ingredients. Quality programs should be established and locally developed which encourage information sharing between supplier and customer, as well as monitoring and maintenance of adequate microbiological ‘controls’, appropriate for the materials’ use.
Dr. Ashtekar is Senior Director of Sterility Assurance and Microbiology at Intarcia Therapeutics, Inc. He 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”. He also serves on the International Society for Pharmaceutical Engineering (ISPE) Data Integrity Task Force 2016 and is a Board Member of the Southern California PDA Chapter and INTERPHEX. He has extensive experience with sterility assurance, Quality systems, data integrity, aseptic processing, and terminally sterilized products.
Presentation Title: “Technical and Regulatory Framework: Microbiological Aspects of Cleaning Validation for Non-sterile and Biotechnological Equipment”
Effective control to prevent buildup of bioburden and endotoxin principally depends on the implementation of a robust cleaning validation program. Lot-to-lot consistency for the bioburden and endotoxin contents cannot be assured if the cleaning and sanitization regimens are not properly validated for non-sterile products manufacturing and equipment. This presentation will address the regulatory requirements, strategies for defining the bioburden and endotoxin limits, and development of effective cleaning validation protocols, test methods and acceptance criteria. The presentation will include strategies to determine the initial measure of overall bioload and/or confirmation of the initial titer of the challenge microorganisms. In addition, the presentation will outline requirements for the effective assessment of susceptibility of the challenge organisms to the cleaning and/or sanitization regimens, as well as recovery of the challenge organisms. The strategies for the mitigation of lot-to-lot microbial carryover risk and prevention of the buildup of microbial growth during routine production runs, campaigns and operations will be presented.
Amy Jo Karren
Amy has been with the Medical Products Division of W.L. Gore and Associates since January of 2011, with the commitment of Microbiologist and Lab Leader. Previously she was with Nelson Laboratories, Inc. in Salt Lake City for 17 years where she served as the Director of Scientific Development and the Microbiology Section Leader. She has extensive experience with bacterial endotoxin testing, bioburden testing, environmental control, microbial limits testing, standard plate counts, and microbial water testing. She is also trained as a Sterilization Specialist, which includes ethylene oxide, radiation, steam, and dry heat sterilization. She has implemented test systems for environmental monitoring, bacterial identifications, and biological indicator population verifications. She is a specialist microbiologist (RM/SM) with the American Association of Microbiologists.
Amy was elected to the 2015-2020 USP Council of Experts, serving as the chair of the Chemical Medicines 5 Expert Commitee. She also serves on multiple working groups for the Sterilization Standards (TC198) committee with the Association for the Advancement of Medical Instrumentation (AAMI). Amy is a past a member of the Parental Drug Association (PDA), and was involved in writing technical reports for dry heat sterilization and environmental monitoring. She has served on an ASTM committee for rubber products, specifically for medical gloves.
Amy has been a Certified Quality Auditor and a provisional RAB Lead Auditor. She also was a certified trainer for ISO 9001, 13485, and 17025 standards, including the requirements for RAB auditor training.
Amy received her degree in Biology, with emphasis in microbiology and chemistryfrom Utah State University. She also attended Humboldt State University to study marine biology.
Presentation Title: Tentatively “Training on the Right Things in the Microbiology Laboratory"
Andrew is a Sr. Manager Microbiology Center of Excellence and Lab Controls at
J&J Consumer and 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 a draft hardcover book, “Code of Hygienic Practices” which is being published by the PDA. He has also co-authored a technical report with the PDA, TR 67, Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices and Cosmetics. He has a BS in MedicalTechnology from Kean University and a MS in Microbiology from Wagner College.
Presentation Title: “Contamination Prevention in Nonsterile Manufacturing of Pharmaceutical Drugs, Cosmetics and Medical Devices"
This presentation will include the following steps for an overall microbiological control program:
• Microbiological risk assessment program-what is it?
• Sanitary equipment design principles
• Preventative maintenance of equipment
• Cleaning of equipment
• Sanitization of equipment
• Lessons learned from microbiological risk assessments and investigations (photos)
* Register by 8/1/17 to receive $200 off the regular registration fee!