Why is FDA at my facility, and what do I do during an inspection 2017

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
Medical Device
Pharmaceuticals
Clinical
Dietary Supplements
Food
Nutraceutical
Healthcare IT
Technical Services
Validation
Engineering
Small Business Owners
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

Location: Baltimore, MD Date: April 6th & 7th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: The DoubleTree Baltimore-BWI Airport
Address: The DoubleTree Baltimore-BWI Airport 890 Elkridge Landing Road - Linthicum, MD 21090

Price:

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until February 28, Early Bird Price: $1,295.00 from March 01 to April 04, Regular Price: $1,495.00

Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*


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