How to set up a small-volume radiopharmaceuticals manufacturing facility
Instructor:
Shankar Seetharaman
Product ID: 700475
Training Level: Basic
- Duration: 60 Min
Already radiopharmaceutical manufacturing is under not only GMP but under radiation protection legislations and the facility needs to be in compliance with both sets of expectations. This seminar will set out guidance and advice for those interested in setting up or improving an existing facility.
Areas Covered in the seminar:
- Review of 2003/94/EC
- Review of IRR 99
- PET tracer production
- Radiopharmaceutical manufacturing
Who Will Benefit:
- Organisations involved in building radiopharmacies
- Facility Managers
- Quality Assurance staff
- QPs
- Organisations looking to set up a radiopharmaceutical manufacturing facility
Shankar Seetharaman, had over 20 years international experience with major pharmaceutical companies covering Quality Control, QA management, Production and Regulatory Affairs. Now a QA consultant with Pharmaceutical Development Services Ltd, a consultancy company based in the UK, he specialises in quality systems, auditing, validation, and contractor management, especially for companies in the early phases of development. Shankar is eligible to be nominated as a Qualified Person under the permanent provisions of the EU Directives. He is a Chartered Biologist, a member of BARQA and CQI and has supported a number of PET centers in the UK.
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