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

Why Should You Attend:

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.

This new paradigm forces industry leaders as well as the FDA to rethink their roles in this dynamic regulatory-business environment. Here, quality principles trump the dictates of compliance. If your company fails to respond to this new calling, it may not be able to compete effectively in the marketplace. These quality concepts are based on well-known and tested quality principles that have been shown to be effective. While the "new quality" is gaining, the virtues of compliance are declining.

Attend this 4-hour 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.

Areas Covered in the Seminar:

• 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.

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.

Who Will Benefit:

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 seminar. Below is a list of functions that would benefit from attending:

• 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

Instructor Profile:

Howard, enjoys sharing his 30 years plus experience in starting up, developing, implementing, managing, and remediating pharmaceutical and medical device quality systems. He has a BS in Biology/Chemistry and Political Science as well as work toward an MBA. His ability to quickly learn the technology is demonstrated by his success in applying quality assurance principles to a wide range of pharmaceuticals and medical devices. 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.

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