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
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
Agenda:
Day 1 Schedule
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 Schedule
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
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.
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: [email protected]
Website: http://www.globalcompliancepanel.com
Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900549SEMINAR
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