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All documents shown here are included in the seminar for instant download

Reference material includes four forms

Reference material contains six FDA presentations related to FDA inspections, most frequently cited deviations and responses to 483's

Reference Material includes 200+ typical warning letters/483s/EIRs with GMP  deviations.
With keyword search and instant downloads

- Foreign inspection guide
- Inspection of pharmaceutical QC labs
- Drug manufacturing inspections guide
- FDA Inspections of Clinical Investigators

Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here
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On-line Audio Seminar 327

Are You ready for FDA's 'New' Inspection and Enforcement Practices?

With Industry Proven Tool Kits for Preparation, Conduct and Follow-up

Recorded, available with all reference material at any time

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FDA inspections and enforcement recently have become much more aggressive.  Just a few facts: The number of 483's and warning letters has doubled over the last five years and shipment holds and multiple product recalls have been announced even for global players, one company had to pay 500 M$ fine as a result of failed inspections, and inspectors ask for details they never did before. For the near future FDA expects multifold Increase of Foreign Generic Drug Manufacturer Inspections through the Generic Drug User Fee Amendments (GDFUFA) that will enable FDA to substantially increase the frequency of to every 2 years from currently 6-7 years. In addition the FDA has just released a new powerful guidance listing a variety of  circumstances that can even delay, deny, limit or refuse an FDA  Inspection overall. The only way to survive the new practices is to get up-to-date expert information on the new inspection practices and to prepare your organization accordingly.

Key Questions related to FDA Inspections are:

  • What is FDA's traditional inspection process?
  • Why did FDA change the inspection and enforcement practices
  • FDA is using the risk based approach for inspections, what items are considered high risk?
  • What are the new inspection questions and details we should be aware of?
  • What are most common deviations?
  • What does the new  FDA guide on reasons for "Delaying or Refusing a Drug Inspection" mean in practice?
  • Which type of photographs can inspectors take during an inspection?
  • What are the possible other reasons for delaying, denying or refusing an  Inspection?
  • What to do if we don't agree with the inspector's observations?
  • How can I avoid 483's and Warning Letters: during the inspection, in the exit meeting, afterwards?
  • To what level does FDA expect preventive actions to avoid reoccurrence of the same or similar problem: same equipment, same department, same site, for the entire company?
  • Many times FDA did reject responses to 483s because there was not enough detail, what should be the level of detail?
  • Is the information provided in the seminar also useful for other inspections, e.g., national inspections, or international inspections, such as WHO, EMA or combined inspections, e.g., FDA and EMA plus WHO?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present strategies and give practical recommendations. After the seminar, an extensive list of reference material like case studies, SOPs, templates and examples will help immediate and cost effective preparation for FDA and other inspections.

During the interactive presentation you learn about:

  • Inspection process for API, drug manufacturing and device manufacturing
  • Recent changes: summary and details
  • Going through "Reasons for Delaying or Refusing a Drug Inspection" from the new FDA Guide:
  • 10 Examples of recent observations/deviations that came as a surprise
  • Strategy to respond to the 'New' type of inspections
  • Case study: Going through a typical inspection process
  • Preparing your staff for the 'New' FDA inspections
  • Conducting 'FDA inspection like' internal audits
  • Tips how to respond during inspections to avoid inspectional observations
  • The role of the Exit Meeting to avoid enforcement
  • Developing a corrective action plan with identification of the root cause
  • Developing a detailed preventive action plan to avoid reoccurrence
  • How to use all this information for all national and international inspections

And for easy and instant implementation:
download 10+ documents from special seminar website

  • Updated FDA Inspection Survival Guide: 80 page document everybody should be aware of
  • SOPs:
    - FDA inspections - preparation, conduct, follow up
    (Updated)
    - Responding to FDA 483 Inspectional Observations
    - Responding to FDA Warning Letters
    - Internal audits - The ideal preparation for FDA inspections
  • More than 30 examples of recent FDA GMP 483s/Warning Letters/EIRs
    With keyword search and instant download
  • 10 Case studies
    - Responding to inspectional observations: root cause,
       corrective actions, preventive actions
      The case studies will help to avoid further enforcement
  • FDA Presentations - Leaning from the inspectors
    - Insight on FDA Inspections and Recommendations
    - The Inspection is Over – What Happens Next? Possible
       FDA Enforcement Actions
    - Writing An Effective 483 Response
    - FDA API Inspections
    - FDA cGMP Inspections
    - Laboratory GMPs and Inspectional Issues: an FDA Perspective
  • FDA Guides
    - Reasons for Delaying or Refusing a Drug Inspection
    - Foreign inspection guide
    - Inspection of pharmaceutical QC labs
    - Drug manufacturing inspections guide
    - FDA Inspections of Clinical Investigators
  • PowerPoint Presentation
  • Script
  • All questions and answers from before, during and after the seminar
  • And more....

Expected follow-up to inspectional and audit deviations

Root cause analysis - corrective actions - preventive actions - verification of corrective and preventive actions - Attend the seminar to learn how

Who should attend?

  • QA managers and personnel
  • QC directors
  • Analysts and lab managers
  • Regulatory affairs
  • Internal auditors
  • Training department
  • Documentation department
  • Consultants

Date, time and duration

Recorded seminar, available at any time with all reference material

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web Download

  • Multiple persons - single site
  • Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site.
  • Order includes all reference material.

US$ 399.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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Special offer for Labcompliance Usersclub Members
Recorded Seminar- CD or Web download.

  • Order includes all reference material.
  • for Usersclub information and registration, click here

US$ 299.-
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About audio seminars

 

Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP® Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.

Dr. Ludwig Huber in Panel Discussions with FDA Officials

George Smith, FDA's national Part11 expert, at a panel discussion with Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about computer system validation and e-records.
Ludwig Huber (right) and John Murray, FDA's Computer Validation Expert, (left), speaking at the IVT Computer System Validation Conference.
Mr. Murray explined FDA'snext steps for Part 11


Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:
 Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,