If you operate in a Good Manufacturing Practice (GMP) environment, then your warehouses for starting materials and finished products are regulated and your staff need to be clear on the rules and how to apply them.
SeerPharma offers this training course to help ensure your warehouse operations are GMP-compliant and that your organisation is protecting patient safety by ensuring product quality through Good Warehouse Practice (GWP).
Objectives
At the end of the course participants should understand:
- GMP and how it applies to the warehouse
- codes of practice for GMP and GWP
- what 'compliance' means to warehouse operations
Content
In this course you will learn about Good Warehouse Practices for GMP compliant industries including pharmaceutical and biopharmaceutical. Topics addressed include:
- What is GMP and why is it important?
- Who is responsible for GMP?
- Regulator's view of GMP
- Human factors / behaviour and GMP
- Errors and error management
- Goods receipt > controls > records > housekeeping > returns and recalls
- TGA Guidance on Supplier Qualification
- 6-step plan for Supplier Quality Assurance (QA)
- Example GMP deficiencies
- Managing risk
- Good Documentation Practices
Participants
This course is suitable for GMP Warehouse Managers, Supervisors and operational personnel who are new to the industry / role as well as for refresher or ongoing training (as required by the PIC/S Guide to GMP) of existing staff. It covers fundamental principles of GMP in the warehouse as well as current trends and how to minimise human error.
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 x 3.5 hour sessions over 2 days. Breaks are included.
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.
Sessions
Participants will attend both half-day sessions:
| Sessions | Dates | Times |
| Day 1 | 13th July 2022 | 9:00am-12:30pm |
| Day 2 | 14th July 2022 | 9:00am-12:30pm |
Times are based on Melbourne, Australian Eastern Standard Time (AEST) / Coordinated Universal Time (UTC) +10:00.
Fee and Discount
- AUD $700 (excluding GST) per participant; introductory offer
- 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.
