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2day Inperson Seminar on Surviving an FDA Inspection Understand the Dos and Donts and the Grou

10/10/2013 9:00 AM - 10/11/2013 6:00 PM


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

Contact Information

Event Coordinator

Toll free: 1800 447 9407

Fax: 302 288 6884




NetZealous LLC

161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA

For More Details:

Learn More: 2day Inperson Seminar on Surviving an FDA Inspection Understand the Dos and Donts and the Grou

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