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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.

FDA Faculty Kelly Thomas

Faculty Kelly Thomas

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.  

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Our Past Seminar Testimonial

The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )

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I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals