This training course is designed to help early-stage manufacturers of investigational medicinal products for clinical trials in Australia with understanding the regulatory framework and GMP rules they must comply with.
Content
The course will provide the participants with an overview of the GMP requirements from each chapter and Annex 13 of PIC/S Guide to GMP (PE 009-16). The training will focus on:
- A Quality Systems Approach to Pharmaceutical Development and GMP
- Personnel Roles, Responsibilities and Training
- Facility and Equipment Management, including Qualification requirements
- Document and Record Management
- Production Controls
- Process Validation
- Application of GMP qualification and validation requirements to early phase
investigational medicine
Participants
Personnel involved in projects, product development, clinical trials, quality or operations for manufacturing of investigational products will all benefit from this training by establishing a solid understanding of the regulatory framework governing their business processes and the GMP requirements.
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 is delivered as 2 x 3.5 hour sessions over 2 days. Breaks are included.
An online quiz assessment will be issued by SeerPharma on e-mail after delivery of the course is complete.
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 | To Be Advised | 9:00am-12:30pm |
| Day 2 | To Be Advised | 9:00am-12:30pm |
Times are based on Melbourne, Australia.
Fee and Discount
- AUD $700 (excluding GST) per participant
- A 10% discount applies for 3 or more participants from the same company
Contact us to discuss your interest in a public or private delivery of this course.
