Top Process Validation Mistakes – And How to Avoid Them

Date Jul 17, 2018
Time 1:00 pm to 2:30 pm
Cost 13420.00
Online
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.

Why You Should 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.

Areas Covered in the Session :
  • 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 Should Attend:
  • Manufacturing Engineers
  • Process Engineers
  • Quality Engineers
  • Engineering Managers
  • Quality Managers
  • Auditors
  • Compliance Specialists
  • Validation Specialists
  • Methods Development Scientists
  • QC Analysts

 


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