What Can I Expect During an Audit?

On today’s episode, Stacey Bruzzese presents a recording with clips from a mock audit. The mock audit was recorded at a recent IVT conference and was facilitated by Alyce Deegan, Vice President of Data Integrity at Compliance Path LLC.

What factors impede a zero-findings review?
How can I prepare for an audit review?
What can I expect from the inspectors?
What kinds of questions do they ask?
What is the best way to answer these questions?

These questions and more are covered during the mock audit. This episode has a lot of useful tips for anyone preparing for an audit. For additional information about Alyce’s presentation got to http://www.ivtnetwork.com/article/data-integrity-mock-inspection-mitigating-risk

 

Alyce Deegan has over 20 years of experience in Pharmaceutical, Medical Device and Gene Therapy industries.  Most recently, Alyce was the IT Director of Manufacturing and GxP Lab Systems at Juno Therapeutics a CAR-T Cell Therapy Manufacturing Plant located in Bothell, WA.  Throughout Alyce’s career she has held leadership positions in Quality, Validation and IT at companies such as Pfizer, Biogen and ThermoFisher.  Throughout her career she has built and continues to build "Unified Compliance Models" within companies to address the ever changing regulations and has been directly involved with multiple agency inspections throughout the years.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.