ComplianceOnline

This two day course provides the fundamental knowledge needed to comply with the FDA's cGMP QSR, ISO, and International Medical Device Regulators Forum (IMDRF) (formerly GHTF) requirements for process validation and offers practical advice on how to develop and implement an efficient and effective validation program.

Attendees will learn what, when, why, and how to conduct process validation in compliance with FDA and international agency regulations. Additional topics covered in the course include how to develop pragmatic protocols, maintaining satisfactory validation documentation, how to define and perform the IQ/OQ/PQ validation sequence, analysis of trending data, and evaluating the need for re-validation.

Learning Objectives:

  • Understand when and why validation is required
  • Become familiar with regulatory requirements, industry practice, and associated guidance documents relevant to process validation
  • Understand the consequences of not validating or doing it poorly
  • Define the components of a good validation strategy
  • Application of problem solving methods to help asses which strategy is best in various situations
  • Develop successful validation master plans
  • Define requirements for validation documentation
  • Write a comprehensive protocol
  • Common statistics for sound results
  • Executing the IQ/OQ/PQ validation sequence
  • Establish ongoing process monitoring and control requirements
  • Evaluate when revalidation is needed
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Who will Benefit:

This course is designed for people tasked with ensuring compliance to FDA’s Medical Device Quality System Validation requirements. Following personnel will benefit from the course:

  • Quality professionals
  • Compliance professionals
  • Production supervisors
  • Auditors
  • Manufacturing engineers
  • Design/development engineers
  • Process owners
  • Quality engineers
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Day 01(8:30 AM - 4:30 PM)
  • Registration Process: 8:30 AM – 9:00 AM
  • What is Validation?
    • Validation vs. Verification
    • Types of Validation
    • History and Recent Trends
  • Why Validate?
    • Economic Reasons
    • Consequences of Not Validating – 483 and Warning Letter Examples
  • Regulatory Requirements and Expectations
    • Quality System Regulation 21 CFR 820
    • Industry Guidance Documents
    • Global Harmonization and Expectations
  • Definitions and Terminology
    • FDA vs. GHTF
    • Key Term Glossary
  • When to Validate
    • Processes Requiring Validation
    • Validation Decision Tree
    • Processes NOT Requiring Validation
  • Validation Planning
    • Validation Timing
      • Prospective Validation
    • Defining Your Strategy
      • Establishing the Process Validation Program
      • Validation Trade Offs
      • Validation Process Flow Overview
      • Risk Management as a critical tool
    • Validation Documentation
      • Process Validation Master Plan (PVMP)
      • Protocol
      • Analysis Techniques
      • Policies and procedures
Day 02(8:30 AM - 4:30 PM)
  • Validation Sequence
    • Installation Qualification (IQ)
      • Agency Definitions and Key Components
      • Conducting IQ
    • Operational Qualification (OQ)
      • Considerations and Key Components
      • Measurement and Sources of Variation
      • Experimental Design
      • Sample Sizes
      • Statistical Process Control
      • Process Capability
    • Performance Qualification (PQ)
      • Considerations
      • Summarizing and Reporting Data
      • Ongoing Process Monitoring
      • Revalidation
      • How to Handle Validation Failures
  • Case Studies
    • Validation Strategy and Planning
    • Specific Elements of the Protocols
  • Process Monitoring and Controls
    • Initial Monitoring
    • Ongoing Controls
  • Revalidation
    • When to Revalidate
    • Rationale for NOT revalidating
  • Case Studies
    • Validation Strategy and Planning
    • Specific Elements of the Protocols
  • Questions
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Anne Holland

Anne Holland
Founder and CEO, QA Consulting Inc.

Anne Holland combines more than 25 years of biomedical engineering and quality assurance experience with business acumen as founder and CEO of QA Consulting, Inc., an Austin, TX, based firm founded in 2000. Anne is skilled in every phase of quality assurance from design concept and R&D through manufacturing/ production, and post-market surveillance of medical devices. She specifically focuses on design controls, internal and supplier audits, risk management, process validation, and 483/ Warning Letter remediation.

Ms. Holland received a B.S. in Biomedical Engineering from Vanderbilt University in Nashville, TN, and an MBA from the University of Colorado in Denver, CO. She holds certifications as an ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Engineer (CQE), ASQ Certified Manager of Quality/ Organizational Excellence (CQM), Exemplar Global Quality Management System Lead Auditor, and Society of Quality Assurance Registered Quality Assurance Professional in Good Laboratory Practices.

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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

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