- Are you involved with any authorisation step in a pharmaceutical process?
- Do you need to be aware of the responsibilities of Authorised Persons?
If you answered “yes” to either question, this course can help you understand and execute your GMP / Quality responsibilities so that you and your organisation are compliant with the PIC/S Guide to GMP requirements.
As regulators increase their attention on release for supply processes and personnel, SeerPharma is supporting industry with this dedicated Release for Supply training course. You will learn the duties and responsibilities of Authorised Persons within the context of the Australian regulatory framework and improve your understanding of critical areas including:
- An overview of the regulatory requirements
- Batch Review / Device History Record Review and decision-making on disposition
- GMP and Quality Agreements and the role of auditing and monitoring
- Risk-based approach: Critical Quality Attributes (CQAs) & Critical Process Parameters (CPPs)
- Case study: Using the traffic light system
This course addresses:
- TGA Guidance on Release for supply of medicines (February 2019)
- PIC/S Guide to GMP version 14 (PE 009-14); to be adopted by the TGA from 01 July 2020
This course is suitable for any personnel with any level of responsibility for release for supply under the PIC/S Guide to GMP; including organisations regulated by the TGA (current requirement) or Medsafe (best practice). You may have the final signature or be responsible for authorising some steps in the manufacturing process. You might be involved in quality-related investigations, or need to better understand the obligations of the manufacturer or the sponsor. People from the following functional areas have benefited from this program:
- Quality Assurance
- Quality Control
- Third Party Logistics (3PL)
- Suppliers of Clinical Material
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 1 full day session, with breaks.
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.
Contact us to discuss your interest in a public or private delivery of this course .