ComplianceOnline

Risk-Based Validation of cGMP Systems

Instructor: Richard Poser(PhD)
Product ID: 701363
Training Level: Intermediate to Advanced
  • Duration: 90 Min

recorded version

$299.00
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: Jul-2009

Training CD / USB Drive

$500.00
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: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This Risk-Based Validation training for cGMP Systems will guide you through case studies for the construction qualification, relocation and new equipment installation for a cGMP facility.

Fact:
How much validation is enough? How much is too much? When should you validate what system? Risk-based validation is the new and preferred methodology, assuring that sufficient validation is done to meet regulatory and business requirements.

A case study is presented for the construction qualification, relocation and new equipment installation for a cGMP facility. Over 3,000 systems or pieces of equipment were installed or relocated. A risk-based approach to validation was employed, dramatically reducing the cost and time for facility qualification. Comments by regulatory inspectors will be discussed.

Areas Covered in the seminar:

  • Risk-Based Validation.
  • Equipment and Utility Qualification.
  • Risk management Tools.
  • Functional Risk Analysis.
  • Risk Scoring.
  • Risk Mitigation.
  • Score-Based Validation.
  • Project Outcomes.

Who will benefit:

This webinar will provide valuable assistance to all regulated companies that need to validate qualify or their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
  • End-users responsible for applications that need to be validated
  • QA managers and personnel
  • Information Technology managers and personnel
  • Validation specialists
  • Engineers
  • Facility staff

Instructor Profile:
Rich Poser, is President of First Quality Inc., a quality consulting firm focused on Quality Systems, Training and Validation. Their clients include biotechnology, pharmaceutical and medical device manufacturers, as well as the vendors such as contract laboratories, instrument manufacturers, contract manufacturing sites and software developers that support these highly regulated industries.

Dr. Poser was Director of Analytical Sciences and later Director of Information Systems at the Fisons Pharmaceuticals site in Rochester, NY. Following work in product development, laboratory automation, and validation and quality systems for the Mylan Pharmaceutical Company, Rich joined Dura Pharmaceuticals in San Diego as Analytical Laboratory Director and Director of R&D Quality Assurance. After the acquisition of Dura by √Član, Rich was appointed Director of Quality Laboratory Operations and led their 21CFR Part 11 training and audit team.

Now in private practice as a quality consultant, he also lectures at UCSD Extension in validation, cGMP Regulations and analytical methods validation, and has presented or chaired public seminars on cGMP Requirements, Computer System Validation, Vendor Qualification Auditing, Analytical Methods Validation and Infrastructure Qualification.

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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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