PRI Training's MedAccred Process Validation: Part 2 expands the Part1 GHTF training with examples, discusses the essence for elements of establishing the “process” for process validation, expands on statistical approaches, and presents the recent regulatory direction emphasizing the “risk based” approach, verification-versus-validation, the movement toward continuous verification/validation, and process validation issues from recent FDA auditing.

MedAccred Process Validation Audit Criteria have been developed and are being included in all MedAccred Task Group Audit Criteria to ensure suppliers have the capability and objective evidence to handle process validation. It is there essential that all MedAccred Stakeholders be knowledgeable in this methodology.

Who should attend?

• MedAccred Auditors
• Staff Engineers
• Task Group Members