- 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 current TGA GMP license and PIC/S GMP (PE 009-13) requirements .
As regulators increase their attention on release for supply processes and personnel, SeerPharma is supporting industry with this dedicated 1-day 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 has been updated to address the February 2019-published TGA Guidance on Release for supply of medicines, consistent with PIC/S Guide to GMP PE 009-13.
Release for supply is relevant to TGA licensed or certified manufacturers and Australian sponsors of a medicine manufactured under the PIC/S Guide to GMP.
This course is suitable for any personnel with any level of responsibility for release 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 Assurance
- Quality Control
- Third Party Logistics (3PL)
- Suppliers of Clinical Material
Format and Course Length:
The 1-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.
Contact us and register your interest in a public session or having this course delivered on-site.