May 16, 2017 | E&O Hotel, Penang, Malaysia

UL’s Linda Chatwin, RAC, JD – Senior Consultant – MD Registration Support Ltd. will be presenting “Workshop on FDA Design Control and Conducting FDA Style Mock Audit” on 16 May 2017 at E&O Hotel, Penang, Malaysia.

The course outlines the below:

1. Design Control and Compliance

  • Why design control is necessary
  • Business benefits to design control
  • FDA Guidance
  • Components of design control
  • How to show compliance

2. Conducting an FDA Style Mock Audit

  • What to do to be in a constant state of readiness
  • Preparations to make
  • Training to give
  • Who to call – what to have ready
  • After the inspection – what is next
  • When FDA calls to schedule an inspection

For more information and to register go to the event website at: