GMP Compliance: Introduction

Description:

If you hold an establishment licence, or run an operation governed by Part C, Division 2 of the Food and Drug Regulations,  you must make sure that you comply with GMP requirements and the marketing or clinical trial authorization when you fabricate, package, label, import, distribute, test and wholesale drugs. You must not place consumers at risk because of poor safety, quality, efficacy, or for not complying with regulations.

Bio-Pharma Organizations are responsible for meeting the requirements outlined in the Regulations and clarified in GMP guidance. You will also need the help and commitment of your suppliers and personnel at all levels of your establishment.

Objectives

  • Understand the basics of Good Manufacturing Practices for medicinal products for human use and the current legal regulations and guidelines;
  • Have the confidence to outline the main GMP requirements related to premises, storage facilities and personnel;
  • Get familiar with the principles of the GMP quality system and quality control and the important procedures when dealing with complaints and recalls;

Contents

  • Regulatory agencies around the world
  • FDA, MHRA/EMEA, TGA , PIC/S
  • Health Canada
  • What does GXP mean?
  • What do you think?
  • GMP solution
  • GMP Works, Activities and processes
  • Evolution of GMP

Attendees

Anyone interested in GMP

General Information

– Training materials will be distributed
– A Certificate of Attendance will be issued to the participants who have attended the training course.

Speaker

Kossi Molley, LSSBB, Chartered Trainer – Managing Consultant

  • Date : 20 Oct 2022 - 21 Oct 2022
  • Time : 10:00 am - 11:00 am (America/Toronto)
  • Venue : Zoom

Purchase Ticket

English Session: Oct 20, 2022
$0.00
$ 0
French Session: Oct 21, 2022
$0.00
$ 0
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[Note: This event will be held on zoom. Attendee will get zoom meeting URL through email]

Organizers

Mivado GlobalPerformance

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