Monday, 12 April 2021


Webinar


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.


Speakers:

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

EXPERIENCE

  • 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

EXPERTISE

  • 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

Moderator:

Viswanadh Kuppa






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