PANEL: Preparing for an FDA inspection: common pitfalls and ensuring your study is ready for approval

About this session

- Reviewing last year’s FDA feedback on audits: what were the main reasons for failure?

- Tips and tricks to ensure you are ready for inspection

- Simplifying processes in order to prepare for an FDA inspection

MODERATOR: Judyth Zahora, Senior Director, Clinical QA and Process Improvement, Zentalis Pharmaceuticals

Speakers

• 

  Judyth Zahora

  Senior Director, Global Quality Systems and Process Improvement · Agenus

  Panelist

• SB

  Samantha Beddows

  Director, Data Management, Oncology · AstraZeneca

  Panelist

• JT

  Jessica Truscello

  Senior Vice President, Clinical Operations · Lava Therapeutics

  Panelist

• BF

  Bryan Fulop

  Associate Director, Laboratory Services, Global R&D Procurement · Teva Pharmaceuticals

  Panelist

• HT

  Haifa Tyler

  Executive Director, Head of Clinical Operations · RiboX Therapeutics

  Panelist