Webinar : Watch on Demand
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?
- Gain an insight into how Regulators are restarting their on-site inspection programs
- Greater understanding of how Regulators are using hybrid approaches to make regulatory decisions
- Learn practical steps to take to help prepare your company for alternative inspection methods
- Understand how Regulators are sharing their inspections findings with each other, and using this information in their regulatory decisions
Watch Now:
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
Viswanadh works closely with biopharmaceutical companies for new business acquisition and positioning Parexel as a key strategic partner for Clinical, Commercial and Compliance segments. He brings on board close to two decades of global experience in corporate development, sales & marketing, new business development and portfolio management across products and services. He holds a Senior Management Program from the Indian Institute of Management, Kolkata and a Master's in Veterinary Medicine with a specialization in Cardiovascular Physiology.
