Audio Seminars

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

We include our 10 most frequently ordered laboratory related SOPs in the seminar for easy and compliant implementation.

We include our 20 most frequently ordered laboratory related forms in the seminar for easy and compliant implementation

FDA Presentation:

Laboratory Inspections

Learn from FDA Warning Letters what inspectors look for and what mistakes other companies make so you can avoid them

Links to GMP regulations and guidelines with impact on Quality Control Laboratories

US FDA, EU, PIC/S, WHO, ICH

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 287

Eight Steps for Cost-effective Laboratory Compliance

Up-to-date overview, hot topics and trends. With tool kit for easy implementation.

Recorded, available with all reference material at any time

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Laboratories supporting API and drug development and manufacturing have to comply with FDA's and/or international GxP regulations. While such regulations have been in place since a long time and do not change very often, guidance documents, industry practices and enforcement practices do. What was enough yesterday, is not any more today and even less tomorrow. This is proven by the large number of recent FDA warning letters going to laboratories  So the industry has lots of questions on how to comply most efficiently.

Key Questions related to GMP compliance in QC laboratories:

  • What are the real essential requirements for laboratories?
  • What is FDA's focus during inspections?
  • Where does the industry have most problems to comply?
  • What are the best industry practices to comply?
  • Where and how can we really save costs?
  • Which procedures do we need?
  • How to keep up with ever changing FDA inspection practices and surprises?
  • Once we have achieved compliance, how can we maintain it?
  • How to prepare for an FDA or EU inspection?

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 master plans, SOPs, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • FDA and international regulations and guidelines
  • Recent examples of FDA warning letters related to laboratories
  • GxP regulations along the drug life: development and manufacturing?
  • Compliance along the laboratory workflow: from sampling to data arching
  • Going through eight essential steps to achieve compliance
  • Cost savings through risk based compliance
  • Savings through inspection ready documentation
  • Savings through leveraging supplier support
  • Maintaining the laboratory compliance
  • Preparation for FDA inspections
  • Recommendations for implementation

And for easy and instant implementation:
download 20+ documents from special seminar website
Attendees have access to the seminar reference web site for at least two years for on-going updf 

  • Laboratory compliance master plan
  • Laboratory compliance: Step by Step
  • 20 Forms for cost-effective implementation
  •  9 SOPs:
    - Handling OOS results
    - Laboratory Failure Investigations
    - Conducting Management Reviews
    - Generation and Maintenance of Laboratory SOPs
    - Validation of Analytical Methods
    - FDA Inspections: Preparation, Conduct, follow-up
    - Change Control of Analytical Equipment
    - Training of Laboratory Personnel
    - Auditing Analytical Laboratories
  • Worksheets/Checklists/Examples
    - Laboratory Audits
  • FDA Presentation
    - Laboratory inspections
  • Regulatory Reference Document
    - FDA cGMP Requirements for Laboratory Records
    - FDA cGLP Requirements for Laboratory Records
  • 20 Recent Warning letters and/or Inspectional observations related to Laboratories
  • FDA Guidance for Industry:
    Inspection of Quality Control Laboratories
  • PIC/S Training Guide for Inspectors: Inspections of QC Laboratories

Who should attend?

  • FDA/EU regulated laboratories
  • Analysts and lab managers
  • QA managers and personnel
  • Validation specialists
  • Regulatory affairs
  • IT professionals
  • Human resources (HR) managers and staff
  • Training departments
  • Documentation department
  • Consultants. teachers

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,