2020 PMF Virtual Fall Forum: Achieving GMP Compliance During the COVID-19 Pandemic

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.

Presentation Topic: Controls to Minimize Disruption to the Pharmaceutical Supply Chain During the COVID-19 Pandemic 

Abstract: The possible impact of the COVID-19 pandemic on the pharmaceutical supply chain is assessedand recommendations are listed for risk mitigation steps to minimize supply disruption to pharmaceutical drug products. Areas addressed include a brief history of the COVID-19 viral pandemic, a description of the virus and it attributes, the screening of employees, the persistence of the virus in the air on inanimate surfaces, cleaning and disinfection of manufacturing facilities, the use of GMP-mandated personal protective equipment to counter the spread of the disease, the role of HVAC systems in viral clearance, the susceptibility of mammalian cell cultures to SARS-CoV-2 and the recommended approaches to risk assessment and mitigation.

Rick Jakober  

Vice President, Laboratory Services, Perritt Laboratories, Inc.

Rick Jakober is the Vice President, Laboratory Services, at Perritt Laboratories, Inc.  He earned a B.S. in Environmental Sciences at Cook College, Rutgers University. 

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 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. 

Presentation Topic: The New Frontier - Surviving the Virtual Audit

Abstract  

 If you’ve ever been on the receiving end of an audit of your microbiology lab, you know how stressful that situation can be, regardless if it’s the FDA, a client audit or even an internal company audit. With COVID-19 disruptions, companies and contractor/vendors have had to develop clever new ideas for audits. The latest has been the virtual audit – an audit done remotely and virtually. My discussion will discuss our experiences with these new types of audits, and will include things to do (and not to do!). We will discuss tips to prepare your audit, documents to share (and maybe not share), what to do and say during the audit, can or should the facility be live-streamed or can the required observations be done using photographs. We will also discuss ways to help you avoid audit traps and how to address audits finding. 

Dilip Ashtekar, Ph.D.   

Chief Consultant, RCMS Consulting Services, LLC

Dr. Ashtekar is a results oriented collaborative and Industry recognized expert leader in Pharmaceutical Microbiology, Sterility Assurance  and Sterile product manufacturing  with over 34 years of successful proven record of handling increasing responsibilities in leading Pharmaceuticals small molecule, Biotechnology (monoclonal antibodies), Biologically derived (microbial fermentation processes) protein therapeutics, Cell therapy, and plasma fractionation and plasma based products, Device  and Vaccine industries.  He is a member of United States Pharmacopeia (USP) Council for Expert Microbiology Committee (2010-Current).  In addition, he serves as one of the key experts several Parenteral Drug Association (PDA) taskforces and authored several Technical Reports (Environmental Monitoring TR 13, Mycoplasma Clearance by Filtration and Rapid Microbiology Methods, TR 33).  He has extensive experience with Sterility Assurance, Quality System, Quality Culture, Data Integrity and sterile Drug Manufacturing, Aseptic Processing, Aseptically Filled products and devices, Radiation and Terminally Sterilized products by moist heat.  

Abstract Title: Strategies for Maintaining Safe Pharmaceutical Manufacturing Operations   in Corona virus SARS-CoV-2 (COVID-19) Pandemic

Abstract: COVID-19 has severely impacted the biopharmaceutical and pharmaceutical parenteral drug manufacturing operations creating drug shortage. This presentation will outline our personal experience based strategies that will prevent the entry and spread of COVID-19 virus  in the manufacturing facility.  COVID-19 virus  that causes COVID-19 infection is thought to spread mainly from person to person, mainly through aerosolized respiratory droplets and virus carrying particles in air  produced when an infected person coughs, sneezes, or talks and through fomites.  This presentation would highlight preventive strategies, including risk analysis, to control virus and virus carrying particles through optimization of HVAC control measure, use of air ionization system, viral environmental monitoring, and remediation approaches.

Crystal Booth, M.M.

Regional Manager, PSC Biotech Corporation 

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. 

Presentation Topic: Using Aseptic Technique to Protect Yourself from COVID-19 

Abstract: During this COVID-19 Pandemic, we have all heard it.  Wash your hands with soap and water for at least 20 seconds.  That is the best defense to stay healthy.  There are lots of tips circulating on media outlets to stay healthy; essential household and basic first-aid supplies are hard to find; and people are dying at frightening clips.  This session focuses on transferring basic aseptic techniques and good hygiene practices learned in the pharmaceutical industry to help protect you from the novel coronavirus.

TIME	TOPIC	PRESENTER
10:00 - 10:15	Introduction/Opening Remarks/Intro Speaker 1	Robert Westney
10:15 - 11:15	Key Note Speaker To Be Announced
11:15 - 11:30	DISCUSSION/Q&A/Intro Topic 2
11:30 - 12:30	Controls to Minimize Disruption to the Pharmaceutical Supply Chain During the COVID-19 Pandemic	Tony Cundell
12:30 - 12:45	DISCUSSION/Q&A
12:45 - 1:00	BREAK – Vendor presentation/prize drawing
1:00 - 2:00	The New Frontier - Surviving the Virtual Audit	Rick Jakober
2:00 - 2:30	DISCUSSION/Q&A/Panel
2:30	End of Session 1 – Request for Evaluations	Robert Westney

TIME	TOPIC	PRESENTER
10:00 - 10:15	Introduction/Opening Remarks/Intro Speaker 4	Robert Westney
10:15 - 11:15	Strategies for Maintaining Safe Pharmaceutical Manufacturing Operations   in Corona virus SARS-CoV-2 (COVID-19) Pandemic	Dilip Ashtekar
11:15 - 11:30	DISCUSSION/Q&A/Intro Topic 5
11:30 - 12:30	Using Aseptic Technique to Protect Yourself from COVID-19	Crystal Booth
12:30 - 12:45	DISCUSSION/Q&A
12:45 - 1:00	LUNCH BREAK – Vendor presentation/prize drawing
1:00 - 2:00	Alternative Methods of Auditing Suppliers	James Quinn
2:00 - 2:30	DISCUSSION/Q&A/Panel
2:30	End of Conference – Request for Evaluations	Robert Westney