ComplianceOnline

Register

Toll Free: +1-888-717-2436

CART 0

Your Shopping Cart

Contains 0 items
Total: $0.00
View Shopping Cart
Cart Image



Managing FDA Inspections from Readiness through Follow Up Responses

By:
Jonathan M. Lewis, Founding Partner, Reliant FDA Experts™…a Division of Advanced Biomedical Consulting, LLC
Coming soon.. Please contact customer care for new schedule

Course "Managing FDA Inspections from Readiness through Follow Up Responses" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Course Description:

If you are looking for answers to these questions, you would certainly benefit by attending this seminar on managing FDA inspections:

  • Has your company ever been unprepared for an FDA inspection?
  • How should one respond to a 483 or warning letter correctly the first time without hiring a costly law firm?
  • What the agency can and cannot ask for during an inspection?

Well, the answers to these and many, many more typical questions are now available in a simple to understand yet detailed training session designed to help manufacturers of FDA regulated products prepare for, manage, and follow up on inspections.



Learning Objectives:

This course on managing FDA inspection will:

  • Define the steps necessary to prepare for an FDA inspection
  • Discuss details surrounding the management of inspections from announcement to close out meeting
  • Offer responses to FAQs regarding typical inspector requests during inspections
  • Define the methodology for responding to 483 and warning letters
  • Offer templates for response letters
  • Discuss common pitfalls to avoid during an inspection

Seminar Fee Includes:

Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar



Who will Benefit:

This course will provide valuable assistance and guidance to all regulated companies (pharmaceutical, biopharmaceutical, biologics, medical device etc) that are preparing for FDA inspections. The following job titles/ positions will benefit from attending this seminar:

  • Internal Auditors
  • Regulators
  • Legal Departments
  • Compliance Officers
  • Validation Managers
  • QC Managers
  • QA Managers
  • Facilities and Engineering Department Staff
  • Compliance Consultants
  • Senior Management




Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 1:00 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

Welcome and Introductions (15 Minutes)

  1. Brief Background and History of FDA (45 Minutes)
    • Brief history of FDA
    • Regulatory references
    • Terminology
  2. The Law (30 Minutes)
    • What is the law?
    • What are the regulations?
    • What gives FDA the right to inspect?
  3. Why Is FDA Inspecting Us? (30 Minutes)
    • Types of facilities within scope
    • Exempt facilities
    • Reasons for inspections
  4. Who are the Inspectors? (1 Hour)
    • An individual or a team?
    • The typical investigator “Specs”
    • The mind of an investigator
    • The inspector’s goals
  5. Preparing for an Inspection (1.5 Hours)
    • Essential documentation collection
    • The SOP
    • Mock inspection
  6. Managing the Inspection (2 Hours)
    • FDA is here!
    • What to ask
    • What to tell
    • Tours
    • How to manage documentation requests
    • Diffusing situations
    • Closeout
  7. Potential Outcomes of an Inspection (1 Hour)
    • 483s
    • Warning letters
    • Consent decrees
  8. Responding to 483s and Warning Letters (1.5 Hours)
    • The Concept
    • To whom to send the written response
    • Format
    • Commitment
    • CAPA concept
    • Supporting documentation
    • Sample 483 responses
  9. Post Response Activities (30 Minutes)
    • Additional correspondence
    • Meetings with FDA
    • Verification activities
  10. Day 1 Closing Comments and Questions (30 Minutes)

Welcome and Day 1 Reinforcement (15 Minutes)

  1. Practical Application # 1 – Practical Exam (1 Hour)
  2. Practical Application # 2 – 483 Response (2 Hours)
  3. Closing Comments (15 Minutes)
  4. Individual/Open Q&A Session (30 Minutes)




Meet Your Instructor

Jonathan M. Lewis
Founding Partner, Reliant FDA Experts™…a Division of Advanced Biomedical Consulting, LLC

Jonathan M. Lewis, founding partner, Reliant FDA Experts™ - a division of Advanced Biomedical Consulting, LLC, has over nineteen years’ experience in the areas of quality control/quality assurance (QA/QC), regulatory affairs, manufacturing, validation, project management, and executive management in both the industry and in consulting roles. Mr. Lewis has experience in the medical device, diagnostic, biopharmaceutical, pharmaceutical, cosmetic, nutritional supplement, food, and animal food industries.

Prior to founding Reliant FDA Experts™, Mr. Lewis worked for KMI/PAREXEL, a regulatory compliance and validation consulting firm, in increasing roles of responsibility from an entry-level validation engineer to the associate director of consulting. He has worked at RPScherer (Cardinal Health), a contract and proprietary solid oral dose pharmaceutical manufacturing facility, as the QC/validation manager. In addition, he has worked at Telectronics Pacing Systems, a medical device manufacturer, as a sterility assurance laboratory technician.





Register Online


Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at customercare@complianceonline.com


Register by P.O. / Check


Yes, I want to attend "Managing FDA Inspections from Readiness through Follow Up Responses".

If you are paying by check:

Checks should be payable to MetricStream Inc. (our parent company) and mailed to:
2479 East Bayshore Road
Suite 200
Palo Alto, CA 94303
USA

Group Registrations

Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.

2 Attendees - Get 10% off
3 to 6 Attendees - Get 20% off
7 to 10 Attendees - Get 25% off
10+ Attendees - Get 30% off

Register by Wire Transfer




Terms & Conditions to register for the Seminar/Conference/Event

Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.

Media Partners

Sponsors



Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.


Media Partner To Do
  • Banner (min 728x90 or 468x60) on the media partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the magazine and/or website.
  • Dedicated email blast to media partner’s subscribers.
  • Article on the magazine and/or website after the conference.






Local Attractions

This massive, world-famous theme park includes Magic Kingdom Park, Disney - MGM Studios, Epcot, Disney's Animal Kingdom, Downtown Disney, and more.




Opened in October of 1971. One of the most famous theme parks in the world featuring Cinderella's castle with classic rides like Pirates of the Caribbean, Haunted Mansion, Space Mountain, Country Bear Jamboree, Hall of Presidents, etc. Frontierland, Tomorrowland, Liberty Square, Adventureland, and Fantasyland, Great for families with kids 10 and younger.




Theme studios park features Jaws, T2, Twister, Men In Black, etc. and various back lot sets used in the movies. CityWalk is an entertainment venue with many restaurants, night clubs, retails stores and a great party atmosphere. Movie theatre near the entrance. Also Hard Rock Cafe, Jimmy Buffet's Margaritaville, Emiril's, NASCAR Cafe.




Get close to nature with everything from a coral reef and tropical river swim to an aviary and sting ray lagoon at Discovery Cove, a park that's part sanctuary, part adventure.




Have a splashing good time at one of the country's premier water parks, offering rides for all ages.




Featuring open-air shopping, dining and entertainment, with more than 40 specialty retailers, delicious restaurants, and exciting entertainment.




The Living Bible theme park features a re-creation of ancient Jerusalem, craft shops, performances, food stands, and the Temple of the Great King.






Follow us :
We need below information to serve you better