FDA Inspections 2016 - Conference on why FDA at my Facility is, and what do I do During an Inspection

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
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. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies, addressing enforcement actions and mitigating compliance exposure for companies via remediation, compliance engineering support, post-marketing surveillance and vigilance reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing; and working with Notified Bodies, and AR's. David manages regulatory problems (e.g. AE's, MDRs, Agency enforcement, complaints/investigations, field alerts/recalls) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. This is based on analyzing the benefits/risks for informed decision-making and interprets the regulatory precedents and new legislation. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones. David has been previously affiliated with well-known device manufacturers and service providers, including a global CRO and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background and areas of interest and focus.
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
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