Process Validation Requirements & Compliance Strategies

This webinar on Process Validation Requirements will go over the foundations of process validation, with an emphasis on going beyond compliance to achieve a robust process. Review of the fundamentals of process validation, with an emphasis on looking beyond compliance to achieve a robust process.

$1,299.00
Introducing
Purchase using Webinar All-Access Pass
One User Unlimited access to all recorded webinars for 6 Months

Recorded Version Only

(PPT + Recorded Streaming Link)

$299.00
1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section
Last Recorded Date: Dec-2021

CD or USB Drive Only

(PPT + Recorded Training File)

$399.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days
Customer Care

Fax: +1-650-362-2367

Email: customercare@fdatrainingalert.com

Follow us:
Why Should You Attend:

When applied correctly, process validation can result in higher process dependability, higher yields, and lower operating costs.

Areas Covered in the Session:
  • Global Harmonization Task Force requirements (includes FDA and ISO)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Design Qualification
  • Facilities and utilities
  • Strategies for achieving a robust and reliable process.
  • Typical process validation protocols.
Who Will Benefit:
  • Research & Development
  • Quality Engineers and Auditors
  • Manufacturing Engineers
  • Quality Assurance & Quality Control Teams
  • Operations Teams
  • Document Control
  • Device Development Teams
  • Personnel involved in Verification and Validation planning, execution and documentation for devices
Instructor Profile:
Jose Mora Jose Mora

Principal Consultant, Atzari Enterprises

Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems.

Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.

Jose led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices.

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. FDATrainingAlert 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@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

You Recently Viewed