- Are you involved with any authorisation step in a GMP 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 responsibilities so that you and your organisation are compliant with GMP regulations.
As GMP regulators increase their attention on release for supply processes and personnel, SeerPharma is supporting the 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:
- Batch reviews and decision-making on disposition
- GMP Agreements and auditing in contract giving and acceptance
- Process Control Plans and Quality System processes (including risk assessment tools)
- Stability and validation status of product being released
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 recently:
- 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.
Call us or click here to e-mail us and register your interest in a public session or having this course delivered on-site.