CGMP Quality Principles for the FDA Regulated Industries

This two-day course is designed for those who work in a Current Good Manufacturing Practices (CGMP) environment and whose roles and responsibilities require they understand and apply quality principles inherent in in the regulations they must master and enforce.

This course begins by studying important concepts about the role and scope of quality and compliance and the resulting activities as quality and compliance work in multi-functional teams to achieve product safety and efficacy. Then, the GMP systems/elements (i.e. Facilities & Equipment, Personnel, CAPA, etc.) will be identified and categorized. Each category will be compared to each of GMPs to identify and study the similarities and differences providing insight concerning the function of their own GMP system.

Pharmaceutical and device lifecycles will be presented in order to learn not only the lifecycle but also the quality function role from product concept to commercialization and the end of product life.

Product CategoryPrimary GMPInternational Guidance DOCSFDA Guidance Documents & Publications (Example)Relationship To FDA Approval ProcessDrugs/pharmaceuticals BiologicalsICH Q7A Part 210-211 Part 600International Conference on harmonization (ICH) ICH Q1 ICH Q8-ICH Q11)2006 FDA publication, The Quality Systems Approach to the Pharmaceutical CGMPS.IND ANDA NDA, BLAMedical devicesPart 820 ISO 13485International Medical Device Regulatory Forum (IMDRF-formerly GHTF)Inspection of Medical Device Manufacturers (PDF - 707KB) Design Control Guidance for Medical Device Manufacturers510(k) IDECombination ProductsPart 4Dependent on the product combinationCurrent Good Manufacturing Practice Requirements for Combination ProductsTissuePart 1270-1271As ApplicableAs applicable

Learning Objectives:

This course is designed for personnel with all levels of cGMP experience. It will provide cGMP knowledge so they may advance and be prepared for additional responsibilities. Upon completion of this course, attendees will:

• Be able to understand and apply GMP concepts to decision making in a managerial role
• For the beginner, the course provides guidance on how cGMPs apply to their role and responsibilities and how to apply these principles in their daily activities
• For the intermediate & advanced, they will be able to apply what they have learned to better manage quality, solve problems, and make improvements
• To learn about ICH and IMDRF(GHTF) and harmonization documents and gain the perspective of how they may be applied to achieve compliance and improve products and processes to achieve greater customer satisfaction.
• Know the similarities and differences between the FDA's GMP Quality Systems for Active Pharmaceutical Ingredients (Q7A), Drug Product (Part 210/211), Biologicals (Part 600-680) and Medical Devices (Part 820 & ISO 13485)
• Learn the relationships of all the CGMPs to other FDA regulations and to the medical products life cycles
• Have working knowledge of international cGMP regulations
• Know the current compliance “hot spots” that FDA and international authorities look for when inspecting for CGMP compliance
• Know how to better locate regulatory information and to interpret, assess, and make decisions concerning GMP issues

Who will Benefit:

As previously stated, this course is designed for all levels of quality, regulatory, and technical experience. It is also well-suited for many of the typical environments and medical products industry.

• It is ideal for the development, manufacturing, testing, and marketing of combination products because it presents an overall picture of the GMP’s required for combination products.
• For the virtual company, the course provides a guided tour of the product lifecycle and how the requirements for quality and compliance change from development to commercialization and onto post-approval.
• For contractors providing outsourcing to the medical industry, it provides guidance on fulfilling the client’s needs to meet compliance requirements.
• Suppliers to the industry will gain insight and knowledge that will assist them in meeting their clients’ needs for consistent high quality components.

Examples of positions that has the potential benefit include:

• Senior quality managers
• Quality professionals
• Regulatory professionals
• Compliance professionals
• Production supervisors
• Manufacturing engineers

• Production engineers
• Design engineers
• Process owners
• Quality engineers
• Quality auditors
• Document control specialists

Howard Cooper
President, EQACT, INC.

Howard Cooper is an independent quality and regulatory consultant with more than 40 years of hands-on, tactical, and strategic experience designing, implementing, managing, and remediating device, pharmaceutical, and biological quality systems. His technical background helps him understand and apply the technology, his political science helps him understand the regulatory process, and his work on an MBA provides a business perspective. He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Certified Quality Auditor (CQA).

After teaching high school science, Howard joined Anheuser-Busch as a Management Quality Trainee to begin his FDA experience. His ability to quickly learn and apply quality principles resulted in promotions to quality supervision and management. He transferred this experience to a medical device contractor about the time FDA medical device regulations were on the horizon. He applied his comprehensive quality experience to revamp both quality and operations to meet all regulations the ride for the medical device amendments.

As a change agent, he enjoys challenging and persuading others to think outside the box to view quality as a positive and energetic force that can make the difference between business success and failure. He emphatically emphasizes the importance of competent and confident people who develop strong working relationships as they work to constantly improve the organization.

Since becoming a consultant in 2004, he has focused on startup and problematic operations using his “change agent mentality”. During presentations, he frequently relates these experiences to illustrate how he mitigated and resolved

issues.

Howard particularly enjoys and encourages class participation and discussion during the presentation.

For Registration - http://www.complianceonline.com/cgmp-quality-principles-for-fda-regulated-industries-seminar-training-80426SEM-prdsm?channel=speedycourse          

 

Note: Use coupon code  NB5SQH8N  and get 10% off on registration.