PRI Training's MedAccred Audit Criteria Preparation: Sterile Device Packaging course is designed to provide a complete overview of MedAccred requirements related to the Sterile Device Packaging audit, focusing solely on technical aspects. 

After an introduction about MedAccred and MedAccred audits, the Instructor covers the topics below:

• Top Non-conformances (NCRs) including NCRs examples and NCRs responses. Also covered are the different NCRs categories and groupings as well as NCRs reports
• Review of AC8111 & Supplemental Checklists to clarify the requirements of each section of each checklist. The Instructor also presents information on frequently found problems as well as explanations of current requirements and interpretations from the Task Group.
• Preparation for the audit through a description of the planning needed during the six months before the audit, which also details actions that must be taken such as a self-audit and sending advance information to the Auditor.
• What should happen during an Sterile Device Packaging audit, from the moment the Auditor arrives until he leaves after the closing meeting.

Who Should Attend?

• Those that have general oversight responsibilities for MedAccred audits and the need to understand what should be happening
• May be taking over direct liaison responsibilities in companies with experience of MedAccred and need to confirm their understanding
• Are new to MedAccred and will be responsible for managing or directly supporting MedAccred audits