Establishing a Reduced Testing Process for Incoming Materials 2015

Topics

• 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

Who should Attend

Attendees from:

• Laboratory
• QA, QC
• Cost Accounting
• Receiving Warehouse
• External Auditing