To support suppliers, contract manufacturers and OEMs from the medical device industry who are considering seeking MedAccred critical process accreditation, eQuaLearn has created a new 3 hour webinar: MedAccred Audit Preparation. The session has been designed to provide a comprehensive overview for companies that need to understand how to prepare for a MedAccred Audit.

Following a short introduction to the MedAccred program, a PRI Staff Engineer will guide you through the audit process step by step and there will be opportunities for you to ask questions on any aspect of the program. Information will also be provided on how to use PRI’s state of the art audit management software, eAuditNet.

Course Topics Include:

  • MedAccred Program Introduction
  • The MedAccred Audit Process
  • MedAccred Audit Preparation Steps
  • What to Expect During the Audit
  • Post Audit Activities (including examples of common non-conformances and best practices for success)
Webinar Title Date Time Action
MedAccred Audit Preparation
This is a free benefit for MedAccred participants
No sessions at this time    

Designed to provide a complete overview of MedAccred requirements related to a MedAccred audit, taught by an Industry subject matter expert.

Course Topics Include:

  • Scope of the audit
  • Audit preparation best practices and post-audit activity
  • Explanation and clarification of the checklist requirements and checklist appendices
  • Top findings
  • What happens after the audit

Who should attend?

Anyone involved who is seeking a MedAccred Accreditation in the following topics:

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
  • Those that are new to MedAccred and will be responsible for managing or directly supporting MedAccred audits
Course Title Date Cost Action
MedAccred Audit Criteria Review No sessions at this time    

This Level 1 training course provides the basics of Process Validation as initiated by the Global Harmonization Task Force document on Process Validation. This document is considered to be the cornerstone for medical devices’ process validation strategy and focuses on the general applicability to manufacturing (including service and installation) processes for medical devices.

Course Topics Include:

  • Definitions: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
  • Verification versus Validation
  • Statistical Methods and Tools

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 therefore essential that all MedAccred stakeholders be knowledgeable in this methodology.

Who should attend?

  • MedAccred Auditors
  • Staff Engineers
  • Task Group Members

Additional Process Validation training courses will be offered in the near future, covering the following topics:

  • Level 2 expands the Level 1 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.
  • Level 3 concentrates on how unique technologies (such as Injection Molding and the SMT fabrication process) provide a common-based Process Validation approach for those technologies.
Webinar Title     Action
Medical Device Process Validation: Level 1
(WebEx Recording)
    Launch