Establishing a Reduced Testing Process for Incoming Materials 2015 covers topics such as:
- Similarities and differences of regulatory requirements for pharmaceutical, medical device, dietary supplements and food
- The role of materials in the achievement of product quality and customer satisfaction
- Supplier selection and qualification
- Types of quality certificates related to incoming materials
- Material Validation
- Material and laboratory qualification and qualifying and validating the analytical methods used
- Factors to consider in establishing the sample plan to reduce risk
- Collaborative testing between you and your supplier
- Monitoring Analytical Results
- The sampling plan calculation based primarily on Risk Factors
- Working with the Supplier
- Taking Corrective Action
- Going beyond reduced testing to Supplier Certification
- Supplier Disqualification
- FDA Compliance activities related to Reduced Testing
Establishing a Reduced Testing Process for Incoming Materials 2015 brings together attendees from:
- Laboratory
- QA, QC
- Cost Accounting
- Receiving Warehouse
- External Auditing
