A Comparison of ICH Q-10 Quality System and the FDA's Quality Systems Approach (QSA) to the Pharmaceutical cGMPs

01:30 PM ET | 10:30 AM PT | 12:30 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar

"Howard, enjoys sharing his 30 years plus experience in starting up, developing, implementing, managing, and remediating pharmaceutical and medical device quality systems"

FDA guidance documents on Pharmaceutical cGMPs


The ICH and FDA guidance documents on Pharmaceutical cGMPs stress the importance of management's responsibility to meet customer needs by encompassing quality improvement through quality by design (QbD), risk management, process control, and user feedback and experience.
Attend this 90 Mins webinar and learn how you can successfully implement the Quality Systems Approach in your operations. Understand how you can be an active and positive force in driving this paradigm change at your organization.

Why should you attend:

Because these guidance documents focus on management's responsibility to organize for quality and manage resources, all functions are impacted directly or indirectly. Therefore , all departments would benefit from the Webinar.

Learning objectives:

•       Discuss the current quality vs. compliance paradigm.
•       Explain & discuss the background , purpose and ,objectives for the Food & Drug Administration' s issuance of            “The Quality Systems Approach To Pharmaceutical Good Manufacturing Practices” guidance and the ICH's                issuance of ICH-Q10, Pharmaceutical Quality Systems.
•       Translate the terminology used in these guidances into practical and well understood, quality practices and                concepts . Such terms as Quality by Design (QbD), Product Realization, Risk
•       Management, Continual Improvement, Management Review, CAPA, will be studied and discussed.
•       Discuss the organization and content between the documents so that similarities and differences may be                    studied in order to implement these concepts effectively, efficiently, and without duplication.
•       Provide established tools that may be used to implement these quality practices discussed in these guidances.
•       Explain quality and regulatory phases as they relate to the pharmaceutical lifecycle.
•       The Enforcement What, How, When, and Where of these guidances.
•       Purchasing & Finance
•       Engineering and Maintenance

Areas Covered

•       The current quality and regulatory paradigm.
          •       The FD&C Act established the requirements for safety and effectiveness.
          •       Current regulations have failed to ensure safety and effectiveness objectives.
          •       Definition for commonly used terms.
          •       Understanding the battle between compliance and quality.
          •       Cross-functional relationships and their role in achieving quality effectiveness.
          •       The Quality Constitution paves the way to cooperation and teamwork.
          •       Transforming Juran’s Quality Loop/Spiral to the Regulatory Loop.
          •       The Pharmaceutical Lifecycle.
          •       The What, Where, Why, When, and How of FDA Enforcement Status.

•       Dissecting and Analyzing the FDA’s Quality Systems Approach (FQSA) and ICH-Q10.
          •       Background.
          •       Comparison of Scope.
          •       Comparison of Purpose and Objectives.
          •       Comparison of Contents.
          •       Overview of Similarities between FQSA and ICH-Q10.
          •       Overview of Differences between FQSA and ICH-Q10.
          •       Comparisons to FDA, ISO, ICH, GHTF, and other regional regulations.

•       Summary Overview of Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulation            and ICH Q10-Pharmaceutical Quality System.

•       Understanding and Applying the Common Quality System Concepts Embodied in These Standards.
          •       People, Leadership, and Management Responsibility.
          •       The Importance of Resource Management.
          •       Building and Organizing the Quality System.
          •       Achieving a State of Control.
          •       Knowledge Management.
          •       Monitoring of Internal and External Factors Impacting the Pharmaceutical Quality System.
          •       Documenting Policies, Procedures, and the Quality Manual.
          •       Achieving Product Realisation (Realization).
          •       Lifecycles Defined.
          •       Importance of Design To Establish the Master Records.
          •       Risk starts with Design.
          •       Technology Transfer.
          •       Facilities and Equipment.
          •       Material Controls.
          •       Control of Outsourcing.
          •       Process Control’s Dependency on Change Control.
          •       Evaluation & Monitoring Activities.
          •       Maintaining the Quality System Through Management Review and Internal Auditing.
          •       Corrective and Preventative Action.
          •       Technology Transfer.
          •       Continual Improvement.
          •       Six System Inspection Model.

•       Question & Answer, & Discussion

Who will Benefit

•       Quality Organization-all levels
•       All functions of Senior Management
•       Research and Development
•       Production (Improve operations by applying these concepts)
•       Regulatory Affairs
•       Senior & Junior Management
•       Purchasing & Finance
•       Engineering and Maintenance

Industries who can attend

This 90-minute online course is intended for professionals in the all Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel

Speaker Profile

Howard Cooper, CBA, CQM

Howard Cooper, has over 40 years experience in the pharmaceutical and medical device industry creating, implementing, managing & remediating quality systems. This experience has shown his leadership, organizing & problem-solving skills to develop quality systems from scratch or in the role of a change agent to remediate failing systems. This experience includes small and large companies operating in the US, Europe and Japan. He has worked with a wide variety of FDA regulated products such as medical devices, in vitro diagnostic reagents and instruments, in vivo diagnostics, pharmaceuticals (Tablets, capsules, injectables), biologicals, monoclonal antibodies), and combination products.

He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Quality Auditor (CQA). His technical education is further complemented by his Political Science degree helping him understand the regulatory process; his work toward an MBA provides business insight. He is a member of ASQ, PDA, AAMI, RAPS, and SQA. He strongly believes that Quality is very influential in shaping successful operations. He knows how to use his leadership abilities to build organizational relationships that make systems operate effectively as well as to develop and empower people.

“I am looking forward to sharing my experience with you to help you learn and better understand quality and regulatory functions and apply them to achieve your goals”

•        Over 40 years of medical device, biological, and pharmaceutical experience in Quality and Regulatory Affairs in startups, small, medium and large corporations.
•        15 years of experience consulting & advising in Quality & Regulatory Affairs (QRAF)
•        This experience includes:
•        Quality and Regulatory Affairs supervision and management
•  &n

Back to Top