Conference - Washington, DC, United States
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. Who Will Benefit: This seminar will provide valuable assistance and guidance to all regulated companies that are preparing for FDA inspections. The employees who will benefit include: • All levels of Management for all departments • QA/QC/Compliance/Regulatory Affairs • Information Technology/Marketing & Sales • Engineering/Technical Services/Validation • Consultants • Operations and Manufacturing Course Outline: 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 About Speaker: David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements. Date, Venue and Price: Location: Washington DC | October 10th & 11th, 2013 | 9 AM to 6 PM Venue: Courtyard Washington Capitol Hill/Navy Yard Address: 140 L Street SE, Washington, District of Columbia 20003 USA Seminar for One Delegate Price: $1,295.00 Register now and save $200. (Early Bird) Discount: Until September 14, Early Bird Price: $1,295.00 from September 15 to October 08, Regular Price: $1,495.00
Sponsoring Institution: GlobalCompliancePanel
(Courtesy of 2-day In-person Seminar's logo, via http://bit.ly/19ZDyvl)
For more information, please visit: http://bit.ly/19ZDyvl
October 10th & 11th, 2013 | 9 AM to 6 PM
Courtyard Washington Capitol Hill/Navy Yard, Washington, DC 2003, USA
Contact Information Event Coordinator Toll free: 1800 447 9407 Fax: 302 288 6884
Contact Name: John Robinson (support@globalcompliancepanel.com)
Contact Phone: 8004479407
If you'd like to ask a question or post a comment about this talk please do so below.
This seminar posting is brought to you by Biotechnology Calendar, Inc. providing access to research information and research tools for nearly 20 years. Visit our Science Market Update Blog for current science funding and market information or see our schedule of upcoming science research laboratory product shows.