The Hybrid Pharmaceutical GMP Quality System – From API To Final Dosage



Does your company need two GMP quality systems – one for API and one for finished products?

Your answer is most likely “that’s the way the FDA or my regulatory body has established the GMP’s”. And that is certainly true. But have you closely analyzed, for example, the objectives of these systems, their content, similarities and differences, and terminology? If you review the history of GMP, you may wonder, “Can I really have a hybrid GMP system combining knowing their similarities but also their differences”?

Next perhaps one may question, “Can there be one GMP system?” We believe this is possible by taking the best from each of the GMP regulations and, perhaps taking the device regulations, with a single system.

Attending this session will provide a fresh perspective on GMP so that you can see possibilities for improving or remediating your current quality systems by:

Understanding that compliance makes only a limited use of quality principles and that there are additional quality principles available that will improve product and process with the added benefit of achieving greater customer satisfaction
Providing a fresh perspective of GMP and demonstrate that the principles of quality are essentially the same in all processes
Understanding that technology/technical processes have inputs and outputs and it is the understanding of these inputs and outputs and their control and analysis that make a difference between success and failure
Management support and participation in the quality system activities will help the company meet its objectives

Areas to be Covered:

Part I – A Primer on How Good Manufacturing Practices Function
Quick Objectives, Overview, Definitions, Similarity & Differences
A quick review of the product lifecycle and the supporting repetitive cyclic processes
Understanding the functions of production, quality control, quality assurance, oversight, monitoring, and supporting functions
Comparing ICH Q7A & Part 210-211
The role of FDA & ICH guidance documents
The Quality Manual and Learning from Part 820, The Quality System Regulation
Factors that influence the decision to merge
Part II – Planning the Merger (Citations from the GMP regulations accompanied by explanation in words and diagrams for each section)
The Role of Senior Management, Organization and Personnel
Documentation, Records and Reports or Quality Manual
Knowledge Management, Design, Risk
Facilities, Process Equipment & Materials
Production & Process Control, Laboratory Controls, Packaging Labeling and Storage and Distribution
The Laboratory, Validation, Change Control, Rejection & Re-Use Of Materials and Outsourcing

Who will Benefit:

QA / QC Managers and personnel
Regulatory Affairs
Product Management
Supervisors & Group Leaders
Production Management
Companies new to the FDA regulated industry
Compliance Management
Quality Unit Vice Presidents & Directors
Vice presidents, Directors and Managers of Operations

Howard T Cooper

Howard T Cooper, President, EQACT, Inc., Independent Consultant, has over 40 years of experience facing the challenges of managing, designing, developing, implementing, and mitigating GMP quality systems in the pharmaceutical, medical device, & food industries. He started his quality career at Anheuser-Busch as a quality management trainee which exposed him to an advanced and preventative approach toward quality. He then took this experience to the medical device industry when the medical device amendments of 1976 were being written and promulgated. He quickly distinguished himself as a change agent and a forward thinking quality leader. Mr. Cooper built on this experience to set up a pharmaceutical /medical device in combination product quality system. Since that time, he has worked with incubators, small companies, and large international corporations in the quality and regulatory affairs. In 2004, he became an independent consultant continuing his work to manage, develop, and implement quality. Mr. Cooper particularly enjoys sharing his experience with others to further develop them for successfully running quality operations.


  Go PRIME   🛈 $ 240 SELECT
  Personal Plan 🛈 $ 3000 SELECT
  Business Plan 🛈 $ 9000 SELECT

  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance