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Tuesday, October 13, 2020 at 10:00 AM EDT
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Wednesday, October 14, 2020 at 2:30 PM EDT

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Mary Ellen Sutton 
The Microbiology Network/Pharmaceutical Microbiology Forum 

585-210-8336 
conference@microbiologynetwork.com 

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

2020 PMF Virtual Fall Forum: Achieving GMP Compliance

 During the COVID-19 Pandemic

 Please note: With the purchase of one web conference registration you will receive one complimentary registration for anyone within your company.

Just announced!  We are honored to host Dr. Ben Machielse, Executive Vice President, CMC, at Novavax.  Dr. Machielse is a widely known industry expert and will present on the topic of industry response to the pandemic.

Please join us on October 13 & 14 for this year's PMF Virtual Fall Forum: “Achieving GMP Compliance During the COVID-19 Pandemic." Leading industry experts will present and discuss topics relating to conducting and receiving remote audits, prevention and control of spread of COVID-19 contamination, as well as other topics relating to achieving GMP compliance during these challenging times.

Achieving and maintaining GMP compliance has presented many unique challenges. The 2020 PMF Virtual Fall Forum will host well-known industry experts who will provide insights into how these challenges can be overcome. As always, the value of this PMF event will be with the collaboration of the presenters and attendees. We encourage you to join!

MAIN TOPICS

  • Controls to Minimize Disruption to the Pharmaceutical Supply Chain During the COVID-19 Pandemic
  • The New Frontier – Surviving the Virtual Audit
  • Alternative Methods of Auditing Suppliers
  • Strategies for Maintaining Safe Pharmaceutical Manufacturing Operations   in Corona virus SARS-CoV-2 (COVID-19) Pandemic
  • Using Aseptic Technique to Protect Yourself from COVID-19  
  • FDA Perspective on GMP Compliance During the Pandemic (tentative) 

WHO SHOULD ATTEND

  • Quality Control Microbiologists
  • Quality Assurance
  • GMP Facilities Engineering
  • GMP Manufacturing
  • GMP Management

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).

Dr. Ben Machielse, Key Note Speaker 

Executive Vice President, CMC, Novavax

Dr. Machielse is a senior executive with 25+ years experience in leading start-ups and large bio-pharmaceutical companies. Worked as entrepreneur in virtual companies and as a senior executive in fully integrated companies. He's a strategic thought leader who values development and implementation of innovative solutions to deliver new products to patients. Dr. Machielse is highly experienced in all aspects of the development and manufacturing of (bio)pharmaceuticals from early stage to marketed products.
Presentation: Controls to Minimize Disruption to the Pharmaceutical Supply Chain During the COVID-19 Pandemic

 

Tony Cundell, Ph.D.  

Consulting Microbiologist, Microbiological Consulting, LLC

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.

James Quinn

Corporate Quality Assurance, Lannett Company, Inc.  

James Quinn is the Director of Corporate and Supplier Quality at Lannett Company, Inc, and has approximately 20 years of experience in quality control and quality assurance.  He obtained his bachelor’s degree in biology from Holy Family University and is currently pursuing his MBA at Fox School of Business.  During his career, James has worked in quality control microbiology, aseptic processing, and quality assurance.  He has developed and/or enhanced quality systems and led remediation efforts for several companies following regulatory inspections. 

Presentation Topic: Alternative Methods of Auditing Suppliers

Abstract: You have had your audits cancelled because of COVID-19.  Suppliers will not allow you onsite for the foreseeable future.  What do you do?  How do you assess a supplier’s quality profile?  How do you manage risk in the absence of a physical audit?  This presentation focuses on tools and alternative methods of auditing while still developing a comprehensive assessment of your suppliers.

 

Tentative Schedule 

Tuesday, October 13

TIME

TOPIC

PRESENTER

10:00 - 10:15

Introduction/Opening Remarks/Intro Speaker 1

Robert Westney

10:15 - 11:15

Key Note Speaker
Controls to Minimize Disruption to the Pharmaceutical Supply Chain During the COVID-19 Pandemic

 

Dr. Ben Machielse

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

 

Wednesday, October 14

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

Register Now! Be sure to add a guest  when you register to take advantage of the current BUY ONE, GET ONE registration opportunity!

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.  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.