ComplianceOnline

Process Validation Requirements & Compliance Strategies for FDA Regulated Environment

Instructor: Jose Mora
Product ID: 700162
  • Duration: 60 Min

recorded version

$249.00
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: Sep-2007

Training CD

$500.00
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 Process Validation Requirements webinar/training will Review process validation basics, with emphasis on looking beyond compliance towards achieving a robust process.

Review of process validation basics, with emphasis on looking beyond compliance towards achieving a robust process.When used as intended, process validation can provide increased process reliability, improved yields, and reduced operating expenses.

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.

What will Attendees Learn:

  • Process Validation strategies
  • Planning ahead for each protocol
  • How to incorporate DOEs and robust process methods into a process validation.
  • Checklists for IQ, OQ and PQ
  • Comparison of OQ and PQ with "old" OQ, Process PQ and Product PQ
  • Proper data recording for process validation

Who Will Benefit:

  • Manufacturing Engineers
  • Quality Engineers
  • Process Development Engineers and Scientists

Instructor Profile:

Jose Mora, is a Sr. Consultant at Streale as well as a partner in Atzari Consulting, LLC. Although he has been in the medical device industry for 24+ years in various companies, he has observed that the same types of issues and principles apply in all cases. Jose has worked as a Director of Manufacturing, Director of Manufacturing Engineering, Sr. Manufacturing Engineer, and as a Quality Systems Manager at companies such as V. Mueller (Cardinal Health), Cordis Corporation (J&J), Mentor Corporation, UroSurge (a startup urology products company), Boston Scientific, as well as several consulting clients. Jose has a BS. in Mechanical Technology from Purdue University.

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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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