Building a Validation Program From Top to Bottom

Jonathan M. Lewis
Instructor:
Jonathan M. Lewis
Duration:
60 Minutes
Product Id:
500159
Access:
6 months

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Price Details
$189 Recorded
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Overview:

Companies face many common issues or confusions that arise while creating a validation program such as, Though company has expertise in process validation but never quite able to keep up with facility and equipment changes requiring never ending equipment qualification (IQ, OQ, PQ). Sometimes matrix approach to cleaning validation has gaps or even worse customer or 483 audit findings due to the program's near impossibility to manage. How PLC-based systems or laboratory equipment should fall within the methods validation program, software validation program, or even the equipment qualification program?

Well, the answers to these and many, many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build (or rebuild) a sustainable validation program.

Why should you Attend: 25% of overall facility costs are associated with validation activities. Don't let the money you spend become a wasteful effort. Companies face many common issues or confusions that arise while creating a validation program such as:

  • Though company has expertise in process validation but never quite able to keep up with facility and equipment changes requiring never ending equipment qualification (IQ, OQ, PQ).
  • What is the difference between a validation master plan and a set of validation SOPs.
  • How PLC-based systems or laboratory equipment should fall within the methods validation program, software validation program, or even the equipment qualification program.

Well, the answers to these and many, many more typical questions are now available in this simple to understand, yet detailed webinar designed to help manufacturers of FDA regulated products build (or rebuild) a sustainable validation program.

Areas Covered in the Session:
  • Define a sustainable structure of a firm's validation program
  • Understand how change control and other quality programs feed into the validation program
  • Define minimal recommended tests and verifications for equipment qualification
  • Discuss what FDA is really looking for in process validation
  • Specify the deliverables associated with software validation
  • Common pitfalls to avoid when executing validation protocols
  • How to estimate costs and time associated with validation
  • How to respond to customer and regulatory audit observations associated with validation
  • Define a sustainable structure of a firm's validation program
  • Understand how change control and other quality programs feed into the validation program
  • Define minimal recommended tests and verifications for equipment qualification

Who Will Benefit:
  • Internal Auditors
  • Senior Management
  • Compliance Officers
  • QA Managers
  • QC Managers
  • Purchasing Managers
  • Validation Engineers and Managers
  • Facilities and Engineering Department Staff


Speaker Profile
Jonathan M. Lewis has over twenty-two years’ experience in the areas of executive management, quality control (QC), quality assurance (QA), manufacturing, regulatory affairs, validation, and project management in both industry and consulting roles. Mr. Lewis has experience in the medical device, diagnostic, biopharmaceutical, pharmaceutical, cosmetic, dietary supplement, food, and animal food industries.

Prior to founding Reliant FDA Experts, a division of Advanced Biomedical Consulting (ABC), LLC, Mr. Lewis worked for KMI/PAREXEL, a regulatory compliance and validation consulting firm, in increasing roles of responsibility from an entry-level Validation Engineer to an Associate Director of Consulting. Mr. Lewis has also worked at RPScherer (Cardinal Health), a contract and proprietary solid oral dose pharmaceutical manufacturing facility, as the QC/Validation Manager. In addition, Mr. Lewis has worked at Telectronics Pacing Systems, a medical device manufacturer, as a Sterility Assurance Laboratory Technician.




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