Top Process Validation Mistakes - And How to Avoid Them

Duration: 60 Minutes
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the essentials of validation. You’ll learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol writing, and change management. We’ll cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices. We’ll discuss the top mistakes that companies make and how you can avoid them.
Process Validation Mistakes
Instructor: Susanne Manz
Product ID: 509627
Objectives of the Presentation
  • The top mistakes people make before starting validation
  • Frequently-seen mistakes made during method validation
  • Common errors made after process validation work is completed
  • Why process development is critical for a good method validation
  • Defining the validation process
Why should you Attend
Process validation is required per regulation to show regulatory authorities that a process consistently produces a result meeting its predetermined specifications. If not performed properly, process validation can result in delays in product development, or even in product quality issues.

Failure to validate is a significant cause of 483 observations. Even worse, it can result in customer complaints, adverse events, and even recalls. In this webinar, you’ll learn how to avoid these problems and use validation concepts to ensure process stability and control. You’ll learn how to conduct process validations and how it can benefit your customers and your business. We’ll cover tools and techniques that can help you successfully validate your processes.

Areas Covered
  • Purpose, scope, and benefits of process validation
  • FDA Expectations, Regulations
  • Lessons Learned and Enforcement Case Studies
  • When to Verify and Validate
  • Process of Verification and Validation
  • Linkages to your Quality System
  • Master Validation Planning
  • Best Practices
Who will Benefit
  • Manufacturing Engineers
  • Process Engineers
  • Quality Engineers
  • Engineering Managers
  • Quality Managers
  • Auditors
  • Compliance Specialists
  • Validation Specialists
  • Methods Development Scientists
  • QC Analysts
$375
Recorded Session for one participant
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Live Session - How it works
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  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has worked at industry leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a CQA (Certified Quality Auditor) from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.

Susanne's new book on Medical Device Quality Management Systems - Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.
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