Monday, 12 April 2021


Regulatory Inspections and the post-COVID-19 restart, are you ready?

Date: 20th May 2021 Time: 04:00 - 05:30 PM

Points Of Discussion:

  • The COVID-19 pandemic's impact on FDA inspections and facility assessment
  • Be prepared for new inspection approaches and focus from global regulators

What do participants get from attending?

  • Greater understanding of how Regulators are using desk-top inspections to make regulatory decisions
  • Learn practical steps to take to help prepare your company for a desk-top inspection
  • Understand how Regulators are sharing their inspections findings with each other
  • Gain an insight into how Regulators will restart their on-site inspection programs in the future

  Register Now:

Please note : If you can't make it on the 20th May 2021, don't worry! Register now and you'll have access to the webinar on demand for 90 days after the live date.


Mark Birse
M.Sc. – Vice President Technical, Parexel, Regulatory & Access

Mark Birse is a Vice President Technical in Parexel's Regulatory & Access Consulting group. He is a strategically orientated regulatory compliance professional, with a career spanning the regulation of pharmaceuticals and medical devices. Mark has a passion for ensuring patient safety through delivering pragmatic, risk proportionate and innovative approaches to regulation, with a demonstrated success in building and leading high performing teams responsible for multimillion-pound income

Lynne Ensor
Ph. D. Vice President, RCS Head of Global Compliance


  • Vice President, Technical at Parexel Aug. 2019 – Sept. 2020
  • 21 years U.S. FDA experience in CDER (Acting Deputy Director for the Office of Process and Facilities/Office of Pharmaceutical Quality and Director for the Division of Microbiology)
  • CDER Master CMC reviewer, Member of the 1st FDA Pharmaceutical Inspectorate
  • Roche Biomedical Laboratories, Clinical Microbiologist


  • Remediation strategies for biopharmaceutical manufacturing facilities
  • Microbiology (Virology/Immunology), Aseptic Processing, Compounding, Biologics/Biosimilars
  • Sterile biopharmaceutical manufacturing and testing – CMC, CGMPs, Risk Assessment & Mitigation, Data Integrity
  • Regulatory policy and guidance development, including harmonization of international regulatory requirements and policy
  • Collaborative leader of multi-discipline teams developing efficient processes. Over 20 years of experience recruiting, training, developing and mentoring staff


Viswanadh Kuppa

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