How to prepare for and host a FDA inspection and respond to 483’s
FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483 warning letter than a disorganized company.
Why Should You Attend:
If a 483 is received knowing how to respond will lessen chances of receiving the FDA Warning Letter.
Areas Covered in this Webinar:
FDA audit inspection process
Facility needed to support inspection
Behavior during inspection-what not to sign
How to prepare personnel
How to prepare facility
How personnel should conduct themselves
How to respond to 483’s
Who Will Benefit:
Manufacturing Management Team
Edwin Waldbusser retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices.
His QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/control and manufacturing/non-conforming product programs.
Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.