cGMP Application for Design and Operation

Product Id : FDA01
Instructor : Jerry Dalfors
Sep 08, 2016 10:00 AM PT | 01:00 PM ET Duration: 60 Minutes


The abbreviation of cGMP is current Good Manufacturing Practice. Such regulations were put in place back in the 1960s and 1970s to ensure that medical systems and employee activities were set up for the benefits of the patients. These regulations minimized the chances of patients being exposed to risks that could arise from medical and drug devices.

The medical operation systems that were set up used to regulate the quality of a manufacturing system, monitoring system and testing that were specific to a medical product. When fully implemented, these regulations used to minimize the risks of patient getting exposed. Employee activities included the immediate documentation of all the activities related to the whole product process as evidence that each step in the production process was followed as prescribed. This documentation also used to serve as a legal evidence that showed that the products were produced according to the set regulations and the testing done on the products was acceptable and suitable for distribution without the fear of patients being put to risk.

This webinar will sensitize manufacturers about the importance of implementing approaches aimed at risk management as well as setting up quality systems that conform to the cGMP regulations. These can be applied during operations and commercial product development after initial pre-clinical studies so that the products can be compliant with the FDA regulations (it is the FDA that enforced cGMP).

The increasing use of outsourcing in the pharmaceutical industry, coupled with the recently publicized CMOs quality issues, have made it necessary to have a quality oversight of the external manufacturers so as to provide GMP compliance assurance. A Quality Agreement is one tool used to accomplish this objective. Each of the proposed Quality Agreement section is analyzed fully and suggested content is written with consideration to the new guidelines. Comparison of the two regulatory documents is presented with differences highlighted and discussed. 

Why Should You Attend?

The FDA strictly checks that all the companies consistently comply with cGMP regulations in the manufacture and production of veterinary and human drugs, medical devices and biological drugs. Thus, it is important for the employees involved in the manufacturing and production of these government-regulated products to be knowledgeable of the required designs and operations that should be followed. This will not only help them to meet the local regulations but also to be on the safe side when the products get shipped overseas. The session will also focus upon understanding of analysis of the proposed Quality Agreement sections with respect to the new guidelines complying with the agreement content. This will also help the companies minimize patient risks while increasing their chances of making profits, as opposed to paying hefty fees to contractors for fixing their errors.

Highlights of the Session

  • Understanding the concept of CGMPs and current quality systems - which include risk management, change control, quality by design and development, CAPA, manufacturing, management responsibilities, resources and evaluation activities
  • Definitions and terms with related acronyms. These are normally used in cGMP applications; it is therefore highly important to know what they mean.
  • QMS – Quality; Its importance in minimizing operational errors and maximizing profitability
  • Best practices for product testing, inspection and document review for final product release
  • What is entailed in Quality Agreement
  • Detailed study of documentation –requirements, data entry, comments and corrections
  • Responsibilities of both the owner and contract facility and the GMP
  • Learn the roles and responsibilities of management in change control and evaluation activities
  • Quality policy – What makes a good quality policy as well as its general elements of the quality manual and individual training requirements for each job description
  • Understand gowning, environmental control and monitoring
  • A critical look at the annual quality reviews, CAPA, change control, and incident tracking in your documentation

Who will benefit?

  • FDA, ISO, PDA, ISPE, ASQ related employees
  • Professional working in industries involved in manufacturing of food, drugs and medical equipments regulated by government agencies
  • Quality Professionals
  • Operation Manager
  • Quality Assurance

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

Speaker Profile:

Jerry Dalfors He has managerial and technical experience in the manufacturing and development of biopharmaceutical products that are highly regulated by the regulatory bodies, such as biologics, injectable, oral dosages and medical devices. His experience spans a period of over 40 years.

Throughout his career, he held the company representative position of most of the major biotechnology and pharmaceutical companies available in the United States. He directly helped and worked with more than 25 companies with their document or quality systems, submittal documents, FDA briefing and project management.

Each of the projects he undertook have been received and accepted by the FDA as well as other regulatory agencies. He also trained many FDA field inspectors and thus is considered as an expert in various aspects of the medical device and biopharmaceutical industries. Though his work has not yet received the 483, it has prevented and corrected many errors as well as helped remediate warning letters.

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