ComplianceOnline

Bringing FDA Pharmaceutical GMPs into the 21st Century

Instructor: Tony Dunbar
Product ID: 700346
Training Level: Basic
  • Duration: 60 Min

recorded version

$149.00
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: Mar-2007

Training CD

$299.00
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 Pharmaceutical training will review the key aspects of Pharmaceutical GMPs for the 21st Century and Quality Systems Approach to Pharmaceutical CGMP Regulations.

This presentation will review the key aspects of Pharmaceutical GMPs for the 21st Century and Quality Systems Approach to Pharmaceutical CGMP Regulations. These documents were issued by the FDA in an effort to bridge the gap between today’s environment and 1978, the date of the last major update to the FDA CGMP regulations governing drug manufacturing. The presentation will include an assessment of the potential impact of FDA’s professed new approach to regulating the pharmaceutical manufacturing sector in the 21st century.The last major update to the FDA CGMP regulations governing drug manufacturing was in 1978. This predates the advent of the Personal Computer (PC), not to mention the Internet! In an effort to bridge the gap, FDA first issued a notice under the heading, Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach, announcing its intention to carry out a systematic reappraisal of FDA’s approaches to product quality regulation. More recently, in September 2006, FDA issued a new Guidance for Industry, Quality Systems Approach to Pharmaceutical CGMP Regulations. This presentation will provide a review of the key aspects of the content of these documents and assess the potential impact of FDA's professed new approach to regulating the pharmaceutical manufacturing sector in the 21st century.

Areas Covered in the seminar:

  • Background to the new guidances
  • Scope and Goal
  • Quality systems approach
  • Risk management
  • Some FDA Initiatives to date
  • Potential impact of new approaches

Who Will Benefit:

This webinar will provide valuable assistance to all manufacturers of human, veterinary and biological drug products (finished pharmaceuticals), who are subject to FDA 21 CFR Parts 210 and 211. It may also be useful for manufacturers of components such as APIs used in the manufacture of these products. The employees who will benefit include:

  • QA managers and personnel
  • Manufacturing managers and personnel
  • Quality system auditors
  • Regulatory affairs
  • Consultants

Instructor Profile:

Tony Dunbar, has over 30 years quality management experience in his career with Parke-Davis, Warner-Lambert, Pfizer and currently with PENSA as their Senior Compliance Consulting Expert. PENSA (www.gmps.com) provide compliance services and validation/compliance software to the Life Science Industries. In his role at PENSA, Tony has provided regulatory compliance guidance to a number of industry-leading clients, in addition to assessments and validation of various computer systems against GMP and Part 11 requirements. Tony has also been a presenter of GMP topics and Part 11 at various industry group seminars. Tony has an M.Sc. degree and is a senior member of ASQ, and a Certified Quality Auditor (CQA).

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Validation, Verification and Transfer of Analytical Methods
Upcoming In-person Seminars by EX-FDA OFFICIALS

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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