COURSE OUTLINE:

Deciding to go remote
–Factors to consider in the decision
–Type of CDMO facility
*Purpose of audit (initial qualification vs. ongoing)
*Previous audit history
*Experience with remote audits
*Confidentiality concerns
*Limitations of remote audits
–Breakout session

Planning the audit
–Technology considerations
*Meeting platforms
*Document sharing
*Tours/observations
–Logistics
*Approaches to structuring a remote audit
*Team structure (audit team vs CDMO)
–Breakout session
Conducting the audit
–Best practices
–Handling unplanned events

The course materials and access link will be sent to all registrants closer to the course date.

SPEAKER: Stephanie Gaulding CQA, CPGP

Registration Deadline: 1 Feb 2021