People responsible for pharmaceutical product quality and/or GMP compliance must be aware of their legal and ethical obligations.
You can only do this if you understand the regulatory environment and intent and requirements of Good Manufacturing Practices; a modern quality system as defined in PIC/S Guide to GMP.
This course will help by stepping you through each chapter and common appendix of version 13 of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-13) Part I, as adopted by the Therapeutic Goods Administration (TGA). Using case studies and examples drawn from industry and consulting experience, you will learn the requirements and how they are applied to your manufacturing environment(s); with a focus on ensuring product quality and the prevention of adulteration and misbranding.
- An overview of the Australian regulatory environment
- GMP Basics: Personnel and Training, Equipment and Facilities, Production and Packaging Controls, Process 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
"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
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 looking for a refresher, 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.
Format and Course Length:
The 2-day course involves a lively mix of case studies / workshops and intensive tutorial sessions. The delivery method is collaborative with a small group and facilitator, which has been shown to enhance learning and critical thinking skills of participants. You will receive copies of all presentation slides and a Certificate.
|Melbourne||03 & 04 December 2019||The Tudor
1101 Whitehorse Road
Box Hill VIC 3128
|Sydney||09 & 10 December 2019||The Portside Centre
Level 5 Symantec House
207 Kent Street
Sydney NSW 2000
|Brisbane||11 & 12 December 2019||Hilton Brisbane
190 Elizabeth Street
Brisbane QLD 4000
Sessions run from 9am to 5pm unless otherwise specified.
Fee and Discount
- AUD $1,500 (exc. GST) per participant
- A 10% discount applies for 3 or more participants from the same company
Option 1 - Online registration and payment by credit card.
|Location||Date||Online Registration and Payment by Credit Card|
|Melbourne||03 & 04 December 2019|
|Sydney||09 & 10 December 2019|
|Brisbane||11 & 12 December 2019||Not available, see option 2 below|
Option 2 - Register by sending an e-mail to email@example.com with the following details and SeerPharma will issue you with an invoice.
- Course: SP6510 GMP - What You Need to Know
- Location: Melbourne, Sydney or Brisbane?
- Details of each participant:
- Participant name (to be on Certificate)
- Job role
- Company name
- Company address
- Participant e-mail address
- Participant phone number
Contact us and register your interest in a public session in an alternative city or having this course delivered on-site.