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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. Course Description: 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: Industries: Departments Types of facilities: 1. FDA regulated Industries Medical Device Pharmaceuticals Clinical 2. Dietary Supplements Food Nutraceutical 3. Healthcare IT Technical Services Validation Engineering Top and Middle Management Quality Assurance/Management Compliance Management Manufacturing Laboratory Regulatory Affairs Information Technology Marketing & Sales Operations Research & Development Manufacturing facilities Contract manufacturing facilities Distributors Packaging, Labeling API Suppliers Laboratories Importers Documentation Management About Speaker: David R. Dills Regulatory Affairs & Compliance Consultant, 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 & PRICE: Location: Dubai, UAE 3rd & 4th February 2014 (Thursday & Friday) 9 AM to 6 PM Venue: WILL BE ANNOUNCED SOON Price: $1,595.00 Register now and save $200. (Early Bird) Until January10, Early Bird Price: $1,595.00 From January11 to February01, Regular Price: $1,795.00 Contact Information: Event Coordinator Toll free: 1800 447 9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com Website: https://www.globalcompliancepanel.com LIVE CHAT SUPPORT ALSO - http://www.globalcompliancepanel.com/chat/client.php EVENT Link - http://bit.ly/1a2KjhO NetZealous LLC, DBA GlobalCompliancePanel, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Phone: 1800 447 9407
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