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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).
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.
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.
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.
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"
* Register by 8/1/17 to receive $200 off the regular registration fee!
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