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2-day In-person Seminar

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


April 6th & 7th, 2017

Time: 9:00 AM to 6:00 PM

Baltimore, MD

Venue: The DoubleTree Baltimore-BWI Airport


Director : David R Dills

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

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

  Register for 5 attendees   Price: $3,885.00
      $6,475.00 You Save: $2,590.00 (40%)*
Register now and save $200. (Early Bird)
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    • Until February 28, Early Bird Price: $1,295.00 From March 01 to April 04, Regular Price: $1,495.00
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.

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

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

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Phone: 1800 447 9407

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Group participations
Get fabulous discounts by participating in groups of two or more.
No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on 1800 447 9407 to have your seats confirmed!

David R. Dills

Regulatory Affairs & Compliance Consultant,

David R. Dills, Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA, Design Dossiers, Technical Files, CMC, NDA, and IDE submissions, currently serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. His background encompasses broad capabilities in regulatory and compliance oversight and governance, including CAPA, Design Controls, Validation, Software Quality with regulatory oversight, FDA Mock Inspections, remediating documentation management systems, Supplier Quality, Adverse Event Reporting, Product Complaints, GxP Training, interpretation and applicability of FDA and international regulations and standards, postmarketing surveillance, ISO 13485 and CE Mark, Medical Device/IVD/Active Implantable Directives. Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EMEA and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.

Location: Baltimore, MD Hotel: The DoubleTree Baltimore-BWI Airport   890 Elkridge Landing Road - Linthicum, MD 21090

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