PDA Webinar: Remote Assessments and Inspections during the COVID-19 Pandemic: Industry Perspectives

On June 29, in the first of a series of webinars, PDA brought together five esteemed regulators, representing MHRA, FDA’s Office of Pharmaceutical Manufacturing Assessment and FDA’s Office of Regulatory Affairs. They provided invaluable insight into how they are handling site assessments and inspections, both for product approval and surveillance purposes, during this unprecedented time.

In the second webinar in this series, we will hear from those in industry who have experienced remote assessments and inspections from FDA, MHRA and other regulatory agencies.

They will share:

• Details regarding their engagement with the regulators, including what happened before, during and after the assessment or inspection.
• Important take-away lessons from their experiences with remote assessments and inspections, and thoughts about best practices to prepare for and host remote assessments and inspections in the future.

Attendees will have the opportunity to ask live questions to the panelists following their opening presentations.

Format:

• There will be presentations with slides by each panelist followed by questions asked by the moderator.
• There will be an opportunity for the audience to submit live questions.

Facilitator:

• Mary Oates, PhD, VP Compliance Services, Lachman Consultant Services

Presenters/Panel:

• Peggy Speight, VP, Enterprise Regulatory Compliance, Johnson and Johnson
• Ian Stewart, PhD, Site Quality Director – Montrose, GSK
• Paula Katz, FDA Regulatory Attorney, Special Counsel, Covington & Burling LLP
• Mary Farbman, PhD, Executive Director, Global Quality Compliance, Merck