GlobalCompliancePanel, DoubleTree by Hilton Hotel Los Angeles Downtown, 120 South Los Angeles Street, Los Angeles, California, 90012, USA
2013-12-05
Overview: Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favorable outcome. This seminar provides background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections. Day 1 – Agenda Lecture 1: How a firm should prepare for an FDA inspection
Lecture 2: Ways to train employees in view of the inspection
Lecture 3: How to ensure that required documentation is in place
Lecture 4: How to interact with the investigator-DO's and DON'T's
Lecture 5: What companies should do when the inspection ends
Lecture 6: How to reply to 483's and warning letters
Lecture 7: Legal implications of non-compliance
Lecture 8: Post inspection actions Day 2 – Agenda Lecture 1: Why inspections are conducted and by what statutory authority Lecture 2: The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents Lecture 3: What is subject to FDA purview and what's off-limits Lecture 4: Understand and apply the do's and don'ts and comprehend that preparation is the key to success Lecture 5: What are the prohibited "Acts" and the enforcement categories that you need to deal with Lecture 6: What you need to know and do to prepare for, during and even after the inspection...and why your inspection response team is key Lecture 7: the Company’s Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel Lecture 8: How to respond to findings and facilitating the documentation and remediation process...and reaching final closure Lecture 9: Define clear responsibilities, roles and goals for personnel involved in SOP development Who Will Benefit: FDA regulated Industries Dietary Supplements Healthcare IT Top and Middle Management Quality Assurance/Management Compliance Management Manufacturing Laboratory Regulatory Affairs Information Technology Marketing & Sales Laboratories Manufacturing facilities DATE, VENUE & PRICE: Location: Los Angeles, CA | 5th & 6th December 2013 | 9 AM to 6 PM Venue: DoubleTree by Hilton Hotel Los Angeles Downtown Price: $1,295.00 Register now and save $200. (Early Bird) Until November 10, Early Bird Price: $1,295.00 From November 11 to December 03, Regular Price: $1,495.00
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