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  Training Agenda Basic Good Manufacturing Practice for Quality Control Laboratory Training
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GMP Training Overview

In the manufacture and quality control of medicinal products, compliance with the GMP rules is the decisive aspect for manufacturing high quality products. For this reason, every staff member in the pharmaceutical industry has to be familiar with the basic GMP requirements

Learning Objectives

The Good Manufacturing Practice Certificate Program provides a comprehensive overview on the best practices regarding management of manufacturing and quality control testing for pharmaceutical products.

The Live Online Training is designed for people who have no or little knowledge of GMP.

  • You get to know the most important pharmaceutical regulations and their importance,
  • you get a basic overview of GMP requirements in pharmaceutical production, and
  • you become familiar with technical terms from the field of GMP and their meaning
  • Understand the regulatory requirements governing GMP compliant QC Labs.
  • Understand how to apply those requirements
  • Understand the regulatory expectations regarding laboratory design and utilities
  • Understand the regulatory expectations regarding laboratory equipment / instrumentation

Training Agenda

These are the areas of focus:

1)    An Introduction to Good Manufacturing Practice (GMP),

2)    CFR Title 21, Parts 58, 210, 211 Overview

3)    GMP in the Warehouse,

4)    Quality Control Laboratory Design

5)    Microbiology in the Workplace,

6)    Cleaning and Sanitation,

7)    Good Documentation Practices - GMP Laboratory

8)    Documentation and Record Keeping, Stability & Training

9)    Contamination Control,

10) Production Controls,

11) Packaging Controls,

12) Quality Assurance and Quality Control

13) Pharmaceuticals Corrective Actions and Preventative Actions (CAPAs).

14) The Regulatory Inspection

15) Deviations / Non-conformances

16) OOS / OOT

17) How to write an effective investigation


Who Will Benefit

This GMP Course will be valuable to all individuals working within or managing a GMP laboratory that supports either the R&D development of a new drug product or the testing and control of commercial drug product released to the market. Obtaining the certification would be beneficial to professionals in:

  • Research and Development
  • Quality Control
  • Quality Assurance
  • Technical Operations
  • Contract Laboratories
  • Regulatory affairs personnel as well as individuals who are responsible for the review or audit of such laboratory data and reports should likewise consider the value of this comprehensive certification in their positions.


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FDA Faculty Kelly Thomas

Kelly Thomas (25+ year exp.)

Vice President, Americas Quality Operations at Stallergenes Greer - Charlotte Metro USA

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.  

Over 20 years’ experience leading facility start-ups, PAI and Routine cGMP Surveillance inspections. Highly successful global regulatory and ISO compliance history with inspections including FDA, EMEA, IMB, JP, Health Canada, and ANVISA. Highly committed to implementing effective contract manufacturing, supplier management and Internal audit programs. 

Strengths include developing staff, maintaining and developing budgets, implementing robust quality systems, communicating and implementing clear Key Performance Metrics (KPIs), conducting Quality Management Reviews and Executive Reports, implementing Lean Six Sigma programs, influencing and implementing positive change, and leading cross-functional teams. 

High degree of quality understanding and ability to apply knowledge of global regulatory requirements particularly with process / equipment validation, new product and technology transfer, lot/process investigations, quality systems, quality control, data trending, lab equipment and validation. 

Goal-oriented and self-motivated. Committed to quality, teamwork, continuous improvement and organizational success. Ability to motivate staff and create positive, team driven, goal achieving organizations.