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

10+ Best Practices Reference Documents: All included in the seminar

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 

 

 

 

 

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 242

Practical Risk Assessment in Laboratories: Step-by-Step

With Risk Master Plan, SOPs and Case Studies for Easy Implementation

Recorded

 

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Since several years regulatory expectations and industry have been switching from 100% validation for everything to risk based compliance. While the principles of risk management are understood in industry and partly implemented in pharmaceutical and device manufacturing this is not the case for  analytical and quality control laboratories, This is a pity because laboratories miss an opportunity to be more effective, but there are also lots of question:. 

Key Questions related to risk assessment in laboratories

  • What are the exact requirements of FDA and international agencies?
  • What are the expectations of inspectors?
  • We have a good understanding on the theory, but are there real examples?
  • Our company applies risk assessment strategies to manufacturiing, but what are recommendations for laboraties?
  • What laboratory operations are most suitable for cost effective risk based methodologies?
  • How to objectively define risk categories: high, medium, low?
  • How to document the outcome of risk assessment?
  • What if the inspectors don't agree with our risk assessment?
  • Are there good case studies for typical laboratory tasks?
  • What type of documents should we develop?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. Using simple practical examples from day-by-day the complete risk management process will be explained step-by-step. Then the same methodology will be applied to most suitable laboratory operations.  After the seminar, an extensive list of reference material like SOPs, templates, forms  examples and several case studies will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • FDA and international requirements
  • Guidance documents from authorities, standard committees and industry task forces
  • Going through ICH Q9: The reference document for (bio)pharmaceutical industry
  • Documents to be developed by laboratories:
  • Step-by-step implementation: Identification, analysis, evaluation, mitigation, review
  • Justification and documentation of the outcome for FDA and management
  • Applying risk assessment for method validation, method verification and and transfer
  • Optimizing system validation and revalidation using risk methodologies
  • Application of risk assessment for handling OOS situations
  • Using risk assessment strategies during supplier assessment

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

  • PowerPoint Presentation
  • Script
  • All questions and answers from before, during and after the seminar
  • Risk Management Master Plan: 40 pages
  • SOP: Risk Assessment for Laboratory Systems
  • SOP: Risk-based Validation of Laboratory Computer Systems
  • Requirements Related to Risk Management: FDA, EU, ICH, PIC/S, Others
  • Case studies: Risk based methodologies for laboratory tasks
  • 10 forms for effective and consistent implementation of risk based methodologies in laboratories
  • Checklist: Risk Assessment in Laboratories
  • Reference paper: Risk-based Validation of Off-the-shelf Computer Systems
    with SOP
  • ICH Risk Management guide: Q9
  • Risk Management Guide of the Global Harmonization Task Force (GHFT)

Who should attend?

  • Laboratory managers and supervisors
  • GMP auditors
  • QA managers and personnel
  • Analysts and other laboratory staff
  • Validation specialists
  • Regulatory affairs
  • Human resources (HR) managers and staff
  • Training departments
  • 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.