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
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
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
18(hours)