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

Topics

• What a Quality Agreement is - and is not
• 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
• Quality Assurance
• Technology Transfer
• Quality Auditing
• Supply Chain
• Regulatory Affairs / Compliance
• Risk Management
• Purchasing