Seminar on Why is FDA at my Facility, and what do I do During an Inspection
Organization:
NetZealous LLC - DBA GlobalCompliancePanel
Category:
OTHER
Geographical Area:
Conferences & Conventions
Start
Date:
7/21/2016
End Date:
7/22/2016
Start Time:
9 AM
End Time:
6 PM
Event
Info:
Course "Why is FDA at my Facility, and What do I do During an Inspection" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. 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. Who will benefit: Industries • FDA regulated Industries o Medical Device o Pharmaceuticals o Clinical • Dietary Supplements o Food o Nutraceutical • Healthcare IT o Technical Services o Validation o Engineering Departments • Top and Middle Management • Quality Assurance/Management • Compliance Management • Manufacturing • Laboratory • Regulatory Affairs • Information Technology • Marketing & Sales • Operations • Research & Development Types of facilities: • Manufacturing facilities • Contract manufacturing facilities • Distributors • Packaging, Labeling • API Suppliers • Laboratories • Importers • Documentation Management
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.
Location: Zurich, Switzerland Date: July 21st and 22nd, 2016 and Time: 9:00 AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON
Price:
Register now and save $200. (Early Bird)
Price: $1,695.00 (Seminar Fee for One Delegate – Without stay)
Until June 20, Early Bird Price: $1,695.00 from June 21 to July 19, Regular Price: $1,895.00
Price: $2,095.00 (Seminar Fee for One Delegate - With stay)
Until June 20, Early Bird Price: $2,095.00 from June 21 to July 19, Regular Price: $2,295.00
Quick Contact: NetZealous DBA as GlobalCompliancePanel
Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900549SEMINAR Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
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