Practical Process Validation Part 1 - Validation Planning, Prerequisites and Best Practices


Instructor: Vinny Sastri
Product ID: 701123

  • Duration: 90 Min
This Validation training will explain the intent and importance of process validation, the connectivity between design control and process validation and the key pre-requisites and steps in process validation. Process validation is critical to the production of high quality, consistent, safe and effective products and devices. Routine end-product testing alone is insufficient to assure the quality, safety and effectiveness of a product or device. It is important that the product acceptance criteria and specifications are quantified, and that the manufacturing processes are well characterized, understood, controlled and validated.
Last Recorded Date: Jan-2009


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Read Frequently Asked Questions

Part 1 in this two-part series will explain the intent and importance of process validation, the connectivity between design control and process validation and the key pre-requisites and steps in process validation including risk management. Effective validation planning, Validation Master Plans and best practices in process validation will also be discussed.

Areas Covered in the seminar:

  • Process Validation and the FDA Regulations (21 CFR Parts 211 and 21 CFR Parts 820).
  • Key terminology.
  • Why validate? Process Validation intent and benefits.
  • Verification and Validation.
  • Types of Validation.
  • Validation Planning and Validation Master Plans.
  • Schedules, roles, responsibilities, and reviews.
  • Process Validation and Design Control.
  • Product specifications and acceptance criteria.
  • Risk analysis.
  • Protocols and documentation.
  • Process Validation - best practices.

Who will benefit:

This Webinar will be of value to all those involved in product development, process development, quality control, quality assurance, and manufacturing.

  • Research and Development personnel
  • Product development personnel
  • Process engineers
  • Manufacturing managers and engineers
  • Validation Managers and Engineers
  • QA/QC managers and personnel
  • Regulatory personnel
  • Project managers

Instructor Profile:

Dr. Vinny Sastri, President of WINOVIA® LLC, and has over 20 years experience in new product development and quality improvement with a strong track record in the healthcare, medical device, electronics and consumer goods industries. He is a certified Six Sigma blackbelt. Winovia LLC a consulting company that provides sustainable solutions new product development, quality improvement and high performance materials with the goal of strategic market penetration, improving efficiencies of products, processes and services, streamlining business processes, reducing operational costs, improving margins and increasing revenues and profits for its clients.

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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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