If you're responsible for any part of pharmaceutical product quality or Good Manufacturing Practice (GMP) compliance, you must understand your legal and ethical obligations.  To understand your obligations, you must understand the regulatory environment as well as the intent and requirements of a Pharmaceutical Quality System and GMP.

On 01 July 2020, the TGA in Australia adopted version 14 of the PE 009 PIC/S Guide to Good Manufacturing Practice for Medicinal Products (excluding Annexes 4, 5 and 14) as the manufacturing principles for:

  • medicines and active pharmaceutical ingredients
  • biologicals that comprise or contain live animal cells, tissues or organs

On 03 May 2021, Medsafe in New Zealand also adopted version 14 of the PE 009 PIC/S Guide to GMP (excluding Annexes 3, 4, 5, 12, 16 and 18) as the standard for GMP audits of the manufacturing and packing of medicines.

This course will help by stepping you through the key requirements of the PE 009-14 PIC/S Guide to GMP Part I. Using case studies and examples drawn from industry and consulting experience, you will learn the GMP rules and how they are applied to your manufacturing environment(s), with a focus on ensuring product quality and the prevention of adulteration and misbranding.

GMP-operators-running-v-shaped-blenders 

Content
  • An overview of the Australian (TGA) and New Zealand (Medsafe) regulatory environments
  • GMP Basics: Personnel and Training, Equipment and Facilities, Production and Packaging Controls, Validation, Quality Control, Out of Specification, Stability Programs
  • Good documentation and record keeping practices
  • Quality Management Basics: a Quality Systems approach to GMP, Quality Risk Management, Managing Changes and Deviations, Product Quality Reviews
  • Workshops exploring common GMP problems and solutions
Testimonial

"I found the GMP – What You Need to Know course an excellent investment in my educational development. The information was presented in a very user-friendly format and language – a sign of an experienced presenter and quality assurance professional. Of particular use were the comparisons between the previously and currently adopted PIC/S. The course notes are a very useful and quick reference guide. I would strongly recommend the course to anybody wanting a quick refresh or for those looking to enter into Quality Assurance". 

Dr Gabrijela Matanović
Regulatory Affairs Manager, Apotex

Participants

This course has been designed to provide personnel new to the pharmaceutical industry with a good understanding of PIC/S GMP and Pharmaceutical Quality System requirements. It also applies to experienced GMP staff needing training on current GMPs in Australia and New Zealand (PE 009-14), or existing companies that require a new GMP licence or GMP certificate from the TGA or Medsafe; including 3rd party logistics (3PL) providers that repack/reprocess medicines.

This training has also been of value to organisations with an APVMA licence. Although the APVMA has its own code of GMP, the fundamental principles are aligned with the PIC/S Guide to GMP.

Format and Course Length

The course will be delivered as an online virtual-classroom training session.

Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.

The training will be delivered as 2 full day sessions. Breaks are included.

PDF Certificates will be provided to participants electronically.

What Do I Need?

Participant needs are very basic. You will need a computer or suitable device with a good internet connection. A headset (headphones with microphone) and second monitor/screen are recommended but not required.

PDF Certificates will be provided to participants electronically.

Sessions

Each participant will attend both full-day sessions:

 Sessions  Dates  Times
 Day 1  7th July 2021  8:45am join for 9:00am-5:00pm
 Day 2  8th July 2021  8:45am join for 9:00am-5:00pm

Times are based on Melbourne, Australian Eastern Standard Time (AEST) / Coordinated Universal Time (UTC) +10:00

Participants to join at 8:45am in advance of a 9:00am start to address any technical issues.

Fee and Discount
  • AUD $1,200 (exc. GST) per participant
    • A 10% discount applies for 3 or more participants from the same company

New Session Dates To Be Advised

Contact us to discuss your interest in a public or private delivery of this course.

Refer to the Terms and Conditions

Jo Sherriff Circle Gradient Grey BG 182x182

Proposed Trainer

Jo Sherriff

Jo is an experienced senior compliance engineer, responsible for developing and executing GMP validation documentation, including validation plans, specifications and qualification protocols. She has experience in cleanroom compliance, equipment compliance, system compliance, as well as cleaning validation and process validation. Jo is also responsible for developing and executing non-GMP regulatory compliance documentation, including project verification plans, verification protocols, site check lists and reports. Jo has a range of regulatory compliance experience - TGA, FDA, DAWR (Biosecurity), OGTR, ARPANSA, SSBA, and Pharmacy Board of Australia, SHPA, PRASA - and is therefore familiar with the relevant regulatory standards and codes - PIC/S, FDA, EU, WHO, ISO, ARGB, AS/NZS. Jo is an experienced presenter of Validation Workshops and Training for inhouse staff, clients and building contractors. She is experienced in development and presentation of Quality Assurance Procedures and conducts Quality Assurance Audits. Jo is a qualified senior chemical engineer with a diverse background in the pharmaceutical and biological industries.