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

 

The reference material includes 6 forms for effective and consistent implementation of risk based methodologies in laboratories

The reference material includes links to most important official regulations and guidelines related to risk assessment 

 

Learn from FDA 483's and from detailed EIR inspection reports  what FDA inspectors look for, what questions they ask and if company's response is satisfactory.  483's and EIR's typically are not available from FDA's public website.

 

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 244

How Much Validation is Enough?

Company Wide Strategy and Tools for Cost-effective Implementation

Recorded

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Doing too much validation can waste a company’s valuable resources. Doing not enough can result in poor quality, system downtime and problems at inspection. The basic question to answer is: how much validation is enough. While this topic has been discussed many time companies still struggle to get good answers..

Questions are:

  • What are minimal regulatory requirements for validation?
  • Are there recommendations from industry task forces?
  • Who in the organization should decide about how much validation is enough?
  • Should this question be evaluated for each validation project or should it be a company wide effort?
  • What are the criteria?
  • How to justify and document as to How much is enough?
  • How to ensure a corporate wide implementation

How does the on-line 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 SOPs, gap analysis, implementation plan templates and examples will help immediate and cost effective implementation. The major focus will be to provide consistent answers based on corporate wide templates, checklists and validation master plans.

During the interactive presentation you learn:

  • Reasons for a wrong validation balance
  •  Help from recent regulatory and industry guidance: FDA, PIC/S,
  • GAMP5, ICH Q9, USP, EU GMPs
  • Extend of validation vs. cost and risk
  • The role of subject matter experts
  • Developing objective criteria
  • Increasing validation efforts along the drug life
  • Flexible validation master plan: the key to success
  • Taking advantage of risk based validation
  • Leveraging vendor validation
  • "Justify and document” your decisions for inspectors and your management
  • Going through case studies and examples
  • Going through most common pitfalls
  • Frequently asked questions and answers

Get 10+ Documents To Do it Right The First Time:
download from special seminar website

  • SOPs:
    - Risk Assessment for Systems Used in GxP Environments
    - Risk Based Validation of Commercial Off-the-shelf Computer Systems
    - Verification of Equipment and Systems According to ASTM E2500
  • Checklist: How Much Validation is Enough?
  • Templates
    - Optimizing Validation Efforts vs. Cost and Risk
    - Validation Activities for Risk Categories
    - Risk Categories based on Compliance Impact
    - - Risk Categories based on Business Impact
  • Most frequently asked questions and answers
  • 2 Case Studies: How Much Validation is Enough?
    - Analytical method transfer
    - Validation of a commercial of the shelf computer system
  • 5 Warning Letters with examples for 'not enough' validation

Who should attend?

  • Everybody dealing with validation in FDA regulated environment?
  • System owners
  • Software developers
  • Metrology groups
  • QA managers and personnel
  • Analysts and lab managers
  • Validation professionals
  • Training departments
  • Documentation department
  • Consultants

Date, time and duration

Order at any time, replay at any time, download the reference material at any time.

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.