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A Comparison Of Ich Q-10 Quality System And The Fdas Quality Systems Approach
Why Should You Attend:
The QSA to Pharmaceutical cGMPs and ICH-Q10 are guidance documents that stress the importance of management's responsibilities to meet customer needs by encompassing quality improvement through quality by design QbD), risk management,[link widoczny dla zalogowanych], process control, and user feedback and experience.
This 4 hour course will provide the attendees with the knowledge and insight required to understand and apply the principles and concepts of ICH Q10 and the Quality Systems Approach. This new paradigm forces industry leaders to rethink their roles in meeting corporate objectives and strategies.
It challenges the FDA to focus on the importance of user requirements and assessing results with less importance on compliance to inflexible rules and regulations. The key message is Senior Management must be actively involved in quality operations because it is they who have the authority and responsibility to control and demand that corrective action be taken to ensure quality issues are addressed openly and effectively.
This course will discuss and analyze the purpose, scope, objectives,[link widoczny dla zalogowanych], and content of this guidance. Similarities and differences will be shown. Graphics and personal experience cases are widely used to explain principles and concepts. Its present enforcement status will be provided. Questions and answers will be highly encouraged.
Course Syllabus:
1. 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
- The battle between compliance and quality
- Interrelationship between each organizational function and quality
- The Quality Constitution paves the way to cooperation and teamwork
- Transforming Jurans Quality Loop/Spiral to the Regulatory Loop
- The Pharmaceutical Lifecycle
- Enforcement Status- FQSA and ICH-Q10
2. Dissecting and Analyzing the FDAs Quality Systems Approach (FQSA) and ICH-Q10
- Background
- Comparison of Scope
- Comparison of Purpose and Objectives
- Content and Structure
- Similarities between FQSA and ICH-Q10
- Differences between FQSA and ICH-Q10
- Comparisons to other FDA, ISO,[link widoczny dla zalogowanych], and regional regulations
3. Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulation
- CGMPS AND THE CONCEPTS OF MODERN QUALITY SYSTEMS
- THE QUALITY SYSTEMS MODEL
4. ICH-Q10-Pharmaceutical Quality Systems
- ICH Q10 Objectives
- MANAGEMENT RESPONSIBILITY
- CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY
- CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM
Who Will Benefit:
Middle and Senior Management from all functions involved in establishing and executing corporate strategy and objectives
Quality, Finance, Sales and Marketing, Operations,[link widoczny dla zalogowanych], Procurement, and Human Resources who have an active or supporting role in Quality
Other quality personnel who have the desire and/or potential to advance to quality leadership
Instructor Profile:
Howard Cooper, As a consultant, Mr. Cooper shares his 30 years of quality assurance experience in the pharmaceutical and medical device industries by helping smaller companies and startups to understand, develop, and implement GXP quality systems.
He has successfully designed, staffed, and implemented several startup quality systems that resulted in successful product launches. His leadership style motivates personnel to understand the beneficial effect of the GXPs for the company and its employees. He has the ability to assess situations quickly and objectively by finding and focusing on systemic failures.Topics related articles：

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