CMO Supplier Quality Agreements – How to Comply with New FDA and EU Guidelines for Contract Drug Manufacture 2019

CMO Supplier Quality Agreements How to Comply with New FDA and EU Guidelines for Contract Drug Manufacture 2019 is an event dedicated to a contract between a GMP Contract Manufacturer and a pharmaceutical firm is a Quality Agreement .

Topics

• What a Quality Agreement is and isn’t?
• The Who and What of a good Quality Agreement
• GMP responsibilities
• Responsibilities of the owner vs. contract facility
• A comparison of the new guidelines from the FDA and the EU

Who should Attend

• External Manufacturing / Outsourcing Departments
• Quality Assurance Departments
• Technology Transfer Departments
• Quality Auditing Departments
• Supply Chain Departments
• Regulatory Affairs / Compliance Departments
• Risk Management Departments
• Purchasing Departments