ComplianceOnline

Practical Process Validations - Pack of Two Courses

Instructor: Vinny Sastri
Product ID: 701157
  • Duration: 90 Min

recorded version

$449.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jan-2009

Training CD

$800.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This Validation training will explain the intent and importance of process validation.

Description

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.

Module 1:

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.

Module 2:

Part 2 in this two-part series will detail the key qualification steps in process validation, the use of statistical methodology for sampling plans and acceptance criteria, how to handle deviations, elements of a good validation summary report, change controls and revalidation. Sustainability and maintaining a validated state will also be discussed.

  • Process validation Planning and Prerequisites - recap from Part 1.
  • Installation Qualification (IQ).
  • Operational Qualification (OQ).
  • Performance Qualification (PQ).
  • Statistical tools, techniques and quality metrics.
  • Sampling Plans.
  • Process Control.
  • Deviations and how to handle them.
  • Validation summary reports.
  • Change Controls.
  • Revalidation.
  • Validation Life Cycle.

Who will benefit::

  • 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.

Follow us :
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
Computer System Validation - Reduce Costs and Avoid 483s

Refund Policy

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.

If you have any concern about the content of the webinar and not satisfied 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 customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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