The Objective of Supplier Qualification
- Regulatory background
- Duties and responsibilities of the QP
- Expectations of the authorities
- Importing Active Pharmaceutical Ingredients into the European Union
International Trade Relations – what you need to know
- International trade law
- Applicable commercial legislation
GMP Pre-requisites for Procurement and Outsourcing activities
- GMP training for procurement staff
- Dealing with brokers
- Change Control
- Roles and responsibilities
Outsourcing to Contract Manufacturers and Laboratories - what needs to be considered and who is responsible?
- What activities can you out-source?
- Differences when outsourcing within the EU compared to outside of the EU
- Initiation and Contents of the Technical Agreements
- Validation activities: tasks and responsibilities
- GMP/GDP interface
- Legal and ethical responsibilities
- What can happen when things go wrong?
Logistic Providers: Efficient 3PL Selection and Qualification
- Third Party Logistic Provider (3PL) assessment criteria
- How to qualify 3PLs
- Audit or not?
- Information management (deviations, changes etc.)
- Essential agreements
When things go wrong
- Quality Risk Management to avoid delivery bottlenecks and drug shortage
A modular System for qualifying and maintaining Suppliers
- Integrating supplier qualification in the pharmaceutical quality system
- Interfaces with other departments
Reduced Testing of supplied APIs and Excipients
- What guidance is available on reduced QC testing?
- EU and FDA expectations
- Information required before you start reducing
- Can APIs and excipients be covered within the same approach?
- Practical execution
Workshop on Risk Management in the Supply Chain: A risk based Approach to Supplier Qualification
An interactive session to establish where to best concentrate your resources to maximise the assurance of a reliable supply chain:
- Frequency of Supplier Audits based on Risk Assessment
- Defining risk in the audit program
- Compliance risk assessment