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Who should attend CGMP Quality Principles for the FDA Regulated Industries: 2-Day In-Person Seminar
Senior quality managers, Quality professionals, Regulatory professionals, Compliance professionals, Production supervisors, Manufacturing engineers
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Seminar Summary:

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. (see full course description)

 
 
 

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Training Course Syllabus:


CGMP Quality Principles for the FDA Regulated Industries

Course Description:

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.

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

Course Outline:

Day One (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

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

Day Two (8:30 AM – 4:30 PM)

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

Seminar Summary:

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. (see full course description)

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