Trainings By Informa Markets
Informa


cGMP Workshop

09 Dec - 10 Dec 2020   |   Virtual Course


Course Overview

cGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA.

cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.

Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.

The regulations in the GMP area, and thus also the framework conditions for your company, are constantly changing.

Sooner or later if you are a pharmaceutical manufacturer and want to distribute your products in the US, you will be inspected by FDA.

We will go over each item to be covered in each system and provide examples of what compliance with the regulations looks like and cover some failures too.

This course is designed to help you be prepared for that inspection by letting you know what FDA is looking for in each of the 6 systems that they cover. Compliance Program 7356.002 is the instruction used by FDA investigators to plan their inspections as well as to know what FDA expects them to report on. We will explore this instruction and take the mystery out of the specific objectives.

Benefits of Attending


Upskill training for Pharma Manufacturers on CGMP

Better understanding of how the regulatory authorities look at your operations and how to anticipate problem areas before they create problems for your company during the inspection

Obtain the knowledge of renowned expert who have “been there and done that”

To understand the cGMP Inspection trends in the pharma companies

To obtain current information about FDA activities

Get those cGMP questions answered by the Industry Expert.

How we are different from others in Market

Trainer

Peter Deegan

Director
QMSPharma

Who Should Attend?


Department:

  • Quality
  • Manufacturing
  • Production
  • Regulatory

Designation:

  • Senior Vice-Presidents
  • Vice-Presidents
  • Heads/ HoD’s
  • Directors
  • Senior General-Managers / General-Managers / Assistant General-Managers
  • Managers
  • Sr. Executives / Executives




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