PTI - international

About this Web Seminar

Prepare for your next FDA inspection: it is imperative for all FDA regulated businesses, both newly established and well recognized, US based and International, to update internal risk-assessment and risk-management strategies to become current and compliant with new Agency Pharmaceutical cGMP inspection focuses. During this intensive information session, we will discuss the processes and areas of most interest to the FDA based upon Risk Assessment, understanding the requirements within the 6 Quality Management Systems, and exploring the methods used by the FDA to prepare for that next inspection. Knowing the subsystems with-in the six Quality Management Systems and having a good understanding of how these subsystems set the Audit Trail are critical for a successful inspection. By reviewing the FDA's inspection techniques, your company can be sure it is prepared for and can address those areas of strong interest to the FDA.

You Will Learn About:

• Risk Assessment and Risk Management: use the same tools the FDA uses
• Quality Systems: Determine the sub-systems of the 6 Systems and why they are important to the inspection
• Focus: How to know what the FDA will focus on without having an Inspection Agenda
• Pre-Inspection: Long range planning, preparation and training before the inspection
• Set the tone: How to know you are ready on the first day of the inspection
• The most important part: After the inspection is over, know how to respond

About the Leader:
James E. Ingram, FM, CPP
President
INGRAM Consulting Services

Jim Ingram FM,CPP has over 30 years of management experience in the Food, Cosmetics and Pharmaceutical Industries. This includes over 10 years experience in developing and conducting training in FDA Compliance courses. Throughout his career he has had direct responsibility for compliance with government agencies such as the FDA, EPA and DofA.