Live Webinar Regulatory Compliance in the Pharmaceutical Supply Chain

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Hear By Angela Bazigos who recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom"

FDA's challenge is the restructuring of a company's supply chain

Description

The U.S. Food and Drug Administration (FDA) launched a major initiative to modernize the regulation of drug manufacturing and product quality in 2002. This program calls for the application of modern risk and quality management techniques, the use of engineering knowledge and new manufacturing technologies, and the application and demonstration of cutting-edge science throughout the entire production process.

Why should you attend

Driven by the increase in the number of adverse events and drug recalls in recent years, FDA has changed its method of monitoring drug manufacturing. They introduced systems thinking, quality by design and related processes that assure the quality of any product in manufacturing. This resulted in a new FDA initiative 'Good Manufacturing Practices (GMP's) for the 21st century'. The initiative requires pharmaceutical companies to comprehensively manage patient risk, base new drug submissions and manufacturing approaches on demonstrable scientific principles, and simultaneously implement inspection-ready 'GMP Systems' which embed compliance and quality in their operations. Of particular significance is the risk transfer among products resulting from the new approach of GMP Systems inspections. All products produced at a facility may be considered 'adulterated' if any one GMP system fails inspection. It is possible that a single low-revenue high-risk product may wipe out an entire facility's revenue. The assets and infrastructure of pharmaceutical companies were designed to meet the 25-year old GMP regulations and are now exposed to the new risks brought up by the FDA programs related to quality by design.

One of the practical implications of the FDA's challenge is the restructuring of a company's supply chain. A company will need to manage its risks across products, technologies, and sites, and ensure that its drugs are safe at the point-of-use. This webinar will show the participant how to best achieve this to avoid adverse inspection results or harm to patients.

Areas Covered

•     What is the pharmaceutical supply chain
•     What are the cGMPs (regulatory requirements)
•     Latest FDA (and international) initiatives for Regulatory Compliance
•     How are they implemented using a risk based model
•     How can they be streamlined for production optimization while preserving patient safety
•     How are they inspected both domestically and internationally
•     What are the risks that can impact compliance and inspections
•     How to plan ahead to mitigate those risks or to address them in a way that avoids adverse inspection results.

Who will Benefit

•      Design engineers / managers / senior managers
•      Manufacturing engineers / managers / senior managers
•      Operations managers
•      Purchasing
•      Quality Control / managers / senior managers
•      Design engineers / managers / senior managers
•      Manufacturing engineers / managers / senior managers
•      Operations managers
•      Purchasing
•      Quality Control / managers / senior managers

Industries who can attend

This 90-minute online course is intended for professionals in the Pharmaceutical, consumer products, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Angela Bazigos

Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.

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