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 Category | Primary GMP | International Guidance DOCS | FDA Guidance Documents & Publications (Example) | Relationship To FDA Approval Process |
| Drugs/pharmaceuticals Biologicals | ICH Q7A Part 210-211 Part 600 | International Conference on harmonization (ICH) ICH Q1 ICH Q8-ICH Q11) | 2006 FDA publication, The Quality Systems Approach to the Pharmaceutical CGMPS. | IND ANDA NDA, BLA |
| Medical devices | Part 820 ISO 13485 | International Medical Device Regulatory Forum (IMDRF-formerly GHTF) | Inspection of Medical Device Manufacturers (PDF - 707KB) Design Control Guidance for Medical Device Manufacturers | 510(k) IDE |
| Combination Products | Part 4 | Dependent on the product combination | Current Good Manufacturing Practice Requirements for Combination Products | |
| Tissue | Part 1270-1271 | As Applicable | As 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:
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- 08.30 AM - 09.00 AM: Registration
- 09.00 AM: Session Start
- Quality & Regulatory Processes
- Introductions
- The Food Drug and Cosmetic Act (FDCA)
- The FDA regulatory environment
- From law to regulation-importance of the preamble
- The medical products lifecycle from discovery to post-approval
- The product environment-similarities and differences between medical products
- Regulatory definitions and terms with particular emphasis on Adulteration & Misbranding
- How the regulations define quality?
- Quality vs. Compliance
- The changing GMP paradigm-The Quality Systems Approach & ICH Q10
- The GMP Foundation: Management, People, and Documentation
- Organizing for Quality
- Personnel
- Training
- The Documentation Management Process- “The GMP Constitution”
- Design & Risk
- What is design and where does it began and end?
- Quality System Regulation-Design Control
- Q8-Pharmaceutical Development- “Quality by Design (QbD) and Design Space
- Q9-Quality Risk Management
- Design’s impact on the product lifecycle
- Facilities & Equipment “A Facility Does Not Make a Company”
- Design of Facilities and Equipment
- Lighting, Plumbing, & Containment/Contamination
- HVAC & Environmental Controls
- Equipment and Facility Qualification
- Equipment Cleaning and Maintenance
- Automated Equipment
- Cleaning Validation
- Utilities & Water Systems
- Materials Control: “Anything that touches the process must be controlled”
- Classification of materials according to function and Criticality-Labels, Containers, & Materials
- Preparing material specifications
- Auditing, qualifying, and controlling suppliers and contractors
- Material Qualification
- Control of incoming materials
- What do the regulations require for reduced testing?
- Process Control: “Master Records - The Key to Process Control”
- The role of the Master Record
- Content and requirements for Master Records of all medical products
- Review and Approval of Master Records
- Converting the Master Record to a Batch or History Record
- Controlling Master Record and Batch/History Records
- Another new Paradigm-Process Analytical Technology (PAT)
- Process Validation
- Principles of Technology Transfer
- Packaging and Labeling Controls: “Identify and Protect the Product”
- Why is packaging and labeling is so important?
- Controlling Printed Materials
- Controlling the design and manufacture of Packaging & Labeling Materials
- Examining and storing Packaging & Labeling Materials
- Controlling labeling operations
- Laboratory Controls
- Barr Decision-An important Milestone in Regulation
- Analytical Methods-Scientific Basis, Approval, & Validation
- Pharmacopeias
- Controlling Reagents & Reference Standards
- Laboratory Data-Notebooks, LIMS, & Disks
- Equipment Controls
- Using a Contract Laboratory
- Product Release to Distribution & Returned Product
- QA Responsibilities in Product Release
- Why perform testing on finished products?
- Batch Record Review-By Operations
- QA Batch Record Review
- Close deviations and non-conformances
- Problem Solving
- What Are Deviations and Non-conformances- Why Do They Happen
- Complaints show quality system weaknesses
- Adverse Event Reporting
- The Investigative Team
- Performing investigations to discover root cause
- CAPA Systems-Shared Responsibilities between Quality, Operations, and Senior Management
- Statistical Process Control
- Maintaining and Improving Systems
- Value-Added Internal Auditing can lead to problem discovery and improvement
- Quality Metrics-$$$- will be heard
- Annual Reporting
- Reporting problems to Senior Management
- Quality Tools
- Pre-approval Inspections (PAI) or Prepare, Anticipate, & Implement
- Detailed discussion of participant questions, problems, and issues
- Top CGMP problems FDA sees at companies
- Finale
- Discussion of Hot Topics
- Consent Decree Case Studies
- Questions & Answers
- Quiz with Discussion of Answers
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.
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