Industries: Pharma / BiotechMedical Device

CGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices

Course Director: Steven A. Ostrove, Ph.D.

Course Description

This course is intended for all levels of experience in GMPs and focuses on beginner to intermediate level professionals. It will provide participants with an insight to the current GMPs as outlined in 21 CFR 210/211. The course covers the foundations of the regulations and how they are applied in the bio/pharmaceutical and device market today and near future.

Topics included are:

  • Impact of facility and equipment design on GMP compliance
  • Risk management approach to compliance
  • Vendor qualification
  • Commissioning, Qualification and Validation - Which one to use
  • Problem resolution
  • Part 11 in production and the laboratory
  • Quality Systems

Examples will be taken from the three industries (e.g., 21 CFR 210/211, 600, and 820 as well as ICH guidelines and EU regulations). Current "hot" topics and examples of recent warning letters will also be discussed and evaluated.

Who Should Attend

This three-day course is designed for those who work in a current Good Manufacturing Practices (cGMP) environment (beginners to advanced professionals). It is also designed for those whose roles and responsibilities require that they understand and apply cGMP quality principles to their job.

The course helps the cGMP beginner by presenting an overview of the important concepts in a logical and natural sequence so they can begin to understand GMP regulations and begin applying them. The course is also designed to help both the "cGMP Intermediate" and the "cGMP Professional" by providing valuable insights and examples that will assist them in their quality decision-making, as well as, demonstrating ways to make their present systems more effective.

This course concentrates on 21 CFR 211 which is for finished pharmaceutical GMPs, however, these regulations apply equally to the biotech and device industries. The issues and examples presented are taken from all three regulated industries. The implications of ICH guidance publications (e.g., "The Quality Systems Approach to Pharmaceutical cGMP Regulations", Q9) and EU regulations will also be discussed. As this course addresses cGMP regulations, attendees working with finished pharmaceuticals, combination products, biologicals, APIs or devices will gain insight on how to better structure their respective quality systems in order to more effectively manage compliance for multiple products.

Course Agenda

First Day

GMPs – Regulations-Design

Session 1 - The Regulatory Process

  • Introduction
  • The Food Drug and Cosmetic Act (FD&C)
  • The changing the cGMP paradigm-The Quality Systems Approach (QSIT) & Q10 & Q9
  • Understanding the CFR
  • Differences between Medical Device and Drug development
  • Regulatory definitions and terms with particular emphasis on Adulteration & Misbranding

Session 2 - The GMP Foundation: Management, People, and Documentation

  • Organizing for Quality
    • Management & Quality Responsibilities
    • Production, Purchasing, Maintenance & Engineering & Human-Resources Responsibilities
    • Change Control
  • Personnel
    • Establishing qualifications and experience criteria
    • Roles and responsibilities
    • On the Job vs. Conventional training
    • Hygiene
  • Training
    • Why is training important?
    • Training Effectiveness – Types of evaluations
    • Levels & types of Quality training
  • Documentation Management
    • What is Good Documentation Practice (GDP)?
    • What is the purpose of documentation?
    • The types of GMP documents
    • Document and record retention, archiving, backup and recovery

Session 3 - Excellent Design= Excellent Product?

  • What is design and where does it began and end?
  • Relationship between design and Quality/Validation
  • Design Review – When to implement Q8-Pharmaceutical Development-"Quality by Design (QbD) and Design Space
  • Q9-Quality Risk Management
  • Design's impact on the product lifecycle
  • Principles of Technology Transfer

Second Day

Facilities – Controls-Validation

Session 4 - Facilities & Equipment

  • Types of Facilities – Solid Dose, Aseptic, Biologic, API
  • Facilities and Equipment – the role they play
  • Flows – Material, Air, Personnel
  • Lighting, Plumbing, & Containment/Contamination

Session 5 - Vendors and Materials Control

  • Classification of materials according to function
  • Material specifications
  • Vendor Auditing-qualifying, and controlling suppliers and contractors
  • Control of incoming materials
  • Container Closure and other GMP functions
  • What the regulations require for reduced testing

Session 6 - Commissioning – Qualification – Validation

  • Commissioning vs. Qualification vs. Validation
  • Utility Qualification
  • Equipment and Facility Qualification
  • Equipment Cleaning
  • Maintenance and Calibration
  • Automated Equipment
  • Cleaning Validation
  • Process Validation
  • How much is enough?

Session 7 - Process Control: "Master Batch Records and Validation"

  • The Validation Master Plan
  • Review and Approval of Master Records
  • Converting the Master Record to a Batch or History Record
  • Predicate rules and Part 11 – What are they really
  • Another new paradigm-Process Analytical Technology (PAT)

Session 8 - Packaging and Labeling Controls: "Identify and Protect the Product"

  • Why is packaging and labeling is so important
  • Controlling Labels and other Printed Materials
  • Examining and storing Packaging & Labeling Materials
  • Controlling labeling operations

Third Day

Product Release – Problems-Improvements

Session 9 - Laboratory Controls

  • Sampling
  • Analytical methods-Scientific Basis, Approval, & Validation
  • Pharmacopeias
  • Methods Validation Requirements
  • Equipment Qualification Requirements
  • Controlling Reagents & Reference Standards
  • Laboratory Data-Notebooks, LIMS, & Disks
  • Equipment Controls
  • Using a Contract Laboratory

Session 10 - Product Release to Distribution & Returned Product

  • QA Responsibilities in Product Release
  • Why perform testing on finished products
  • Batch Record Review
  • Recalls

Session 11 - Problem Solving

  • What Are Deviations and Non-conformances-Types
  • 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
  • Close deviations and non-conformances
  • Statistical Process Control

Session 12 - Maintaining and Improving Systems

  • Value-Added Internal Auditing can lead to problem discovery and improvement
  • The use of Quality Metrics
  • 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

Session 13 – Wrap Up

  • Discussion of Hot Topics
  • Consent Decree Case Studies
  • Questions & Answers
  • Quiz with Discussion of Answers

Learning Objectives

This course is designed for personnel with all levels of cGMP experience. It will provide participants with cGMP knowledge so they may advance their careers 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
  • Understand facility and equipment design implications on the final product
  • Know and understand the difference between commissioning, qualification and validation and how and where they are applied
  • Understand and begin implementation of the FDA guidance documents such as "The Quality Systems Approach To Pharmaceutical cGMP Regulations", and other important FDA and ICH guidelines
  • Become knowledgeable of the GMP Risk Management approach for the 21st Century and how it applies to international harmonization
  • 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 interpret, assess, and make decisions concerning GMP issues

Testimonials

"The course was well organized and well presented. I have a better appreciation of the material because the instructor made it easy to follow and understand. Will recommend to others!" Sophia S., Regulatory Affairs, Merrimack Pharma

"I thought the course material was well suited for an introduction to cGMP principles. It discussed many basic parts of the process needed to run a cGMP facility in an easy to understand manner. The instructor provided many insights into the industry and demonstrated a thorough understanding of the subject matter." Jennifer D., Process Development Scientist I, Morphotek

"The training you gave was extremely valuable. Being new in QA and new to the regulations, you gave me resources to find answers to the questions I had. Based on suggestions and clarifications you provided, we have been slowly implementing new programs, that seem to mesh better with the CFRs than what we had before. It is very exciting being involved the productive changes in the way my company runs. Thank you for giving me resources and answering my questions." Patrick B., Quality Assurance Associate, Tedor Pharma

"Very good course! The instructor had good knowledge of both the clinical and regulatory aspects of the subject matter. I would definitely recommend this course to others." Kim Z., Sr. Engineer, Johnson & Johnson
"Small class size helped to make sure individual questions and concerns were addressed. I thought the pace was good - covered a lot of material." Valerie J., QA Pharm Bio, W.L. Gore
"Strong instructor, very knowledgeable on the subject matter. Concise and comprehensive." Nnodum I., President, Nnodum Pharmaceuticals
"The course was very informative. The materials/topics such as validation & facilities are not usually covered in a class like this." Rose S., Senior QA Manager, Elan
"The course director was very knowledgeable in GMP and other areas of Quality Assurance. Relating GMPs to everyday manufacturing helped to put the GMPs into perspective. The atmosphere was very relaxing, and I felt very comfortable asking questions. I would definitely recommend this course to others." Kristen R., Plant Quality Engineer, Amway
"I found the class to be tremendously educational and the teacher highly qualified." Ronit A., DRT Labs