Ensuring Quality & Compliance in a Complex Radiopharmaceutical Supply Chain
- Understand the supply chain by mapping out the key activities involved. Know the regulations that apply to each step of the supply chain.
- Have an effective supplier management program in place. Responsibilities should be clearly defined in the Quality Agreements.
- Discuss supplier audits – examples of audit observations.
- Discuss FDA inspections – the Dos and Don’ts in an FDA inspection.