Deploying and creating an arsenal of compliance knowledge and rankings of priorities that should be at the top, with regards to your preparation for your next FDA visit. Simulated exercises that include role playing for both the FDA regulators and your company’s representatives, will prepare you for your next real inspection. You will learn the best ways along with the best resources to improve your compliance. You will be prepared with the latest guidance and strategies for inspection readiness – at any time, announced or unannounced.

Attendees will learn and comprehend how to respond to FDA questions – what to say and how to say it. Everyone will comprehend the importance of FDA Inspections from both sides of the process. You will improve your compliance, enjoy the activities and be much better prepared for the next time FDA “visits” with you.

Learn from the very best expert who wrote the rules, teach FDA inspectors, train industry Quality specialists, and who themselves were expert FDA investigators.

Managing Your FDA Inspection: Before, During and After

Bad Things Happen, But it Can Get Worse – Understanding FDA Post Market Regulations

Understanding FDA and Avoiding Inspections Leading to Warning Letters, Seizures, Injunctions and Prosecutions

Understanding the FDA’s Regulation of HCT/Ps and Successful Product Development Strategies

Deficiencies in Corrective and Preventive Action (CAPA) systems continue to trigger the largest number of FDA 483s and Warning Letters

Why data integrity has become one of FDA's top concerns -- and how you can avoid being an enforcement target

Examples of FDA Warning Letters citing documentation and change control failures

What are those tools and Where do you find the best data that FDA wants in your CAPA system in order to monitor continuously and improve quality throughout your product’s life cycle

Essential FDA Guidelines and other FDA documents, along with references will be provided

The differences between the generic drug approval process and the innovator drug approval process will be presented

There will be role dynamic playing simulations and discussions on the positive and negative consequences of your interactions with FDA

Comparisons to improper behaviours and responses will be made with appropriate and positive communications

Attendees will learn and comprehend how to respond to FDA questions – what to say and how to say it

Everyone will comprehend the importance of FDA Inspections from both sides of the process

Everybody will learn how to control the pace and the outcomes of these FDA Inspections

You will improve your compliance, enjoy the activities and be much better prepared for the next time FDA “visits” with you

• Executive Management

• Facilities Management

• Plant Head

• Factory Head

• Production Head

• Manufacturing Head

• Regulatory Affairs Head

• Internal & External Auditors

• Documentation Management

• Validation Management

• Quality Assurance

• Quality Control