- Are you involved with any authorisation step in manufacturing GxP regulated product?
- Do you need to be aware of the responsibilities of Authorised Persons?
If you answered “yes” to either question, this course will help you understand and execute your Quality / GMP responsibilities so that you and your organisation release product to market in compliance with the marketing authorisation: Release for Supply (RFS).
Regulatory Landscape in Australia
PIC/S Guide to GMP version 16 (PE 009-16) was adopted by the TGA on 3 June 2024 with a transition period for the new Annex 16 (Authorised person and batch release) to 2 September 2024 allowing manufacturers to assess and plan for any changes needed to comply with Annex 16. The TGA expects that since 3 September 2024 manufacturers will have completed:
- assessment of the impact of the Annex 16 on their operations
- updating quality systems documentation and implementing revised practices
Content
This course will address the PIC/S Guide to GMP version 16 (PE 009-16) Annex 16 (Authorised person and batch release) including new/modified requirements. Note that the TGA is still yet to publish updated guidance on Release for Supply since its adoption of Annex 16.
With regulators increasing their attention on Release For Supply (RFS) processes and personnel, SeerPharma is supporting industry with this dedicated RFS 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 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)
- PIC/S GMP Guide version 16 (PE 009-16) Annex 16 (Authorised person and batch release)
Participants
This course is suitable for all personnel with any level of responsibility for releasing regulated products for supply. 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 / Quality Assurance / Quality Control
- Production / Manufacturing / Packing
- Third Party Logistics (3PL)
- Suppliers
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 half-day 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 | 1 October 2024 | 9:00am-12:30pm |
| Day 2 | 2 October 2024 | 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.
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Contact us to discuss your interest in a public or private delivery of this course.
