Process Validation for Medical Device

DETAILS (Return to Main)

Who Should Attend

• Quality managers, quality engineers and quality technicians involved in the development and manufacturing of medical devices
• Professionals directly involved in meeting the FDA’s quality system requirements such as those in regulatory affairs, quality assurance, process development or manufacturing.
• To maximize the peer learning opportunity, we recommend thay you already have a basic understanding of the quality system regulation, including direct work experience.

Learning Outcomes

• Understand the history of the practice of verification and validation.
• Identify regulatory requirements for the validation process.
• Establish the organization for the validation process.
• Understand the process validation principles and the protocols for drugs and medical devices.
• Know the four phases of the facilities validation process.
• Understand utilities and equipment qualifications.
• Identify supporting compliance programs.
• Understand process capability of design and process qualifications.

Related ASQ Bodies of Knowledge:
Many of the statistical techniques are covered in the CQE, CRE, and CSSBB bodies of knowledge. There will also be some interest or linkage to HACCP Auditor certification.

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