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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 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 266

How to Develop an FDA Compliant Risk Management Master Plan

The most important document for efficient and consistent risk management

Recorded, available with the reference material at any time

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Risk management can significantly reduce resources for validation and compliance. It is the most significant innovation in compliance in the last 20 years. A risk management master plan is a company's single most important source document for effective and consistent implementation of risk management projects. While most companies have a validation master plan to streamline validation processes, this not the case for risk management. However, a risk management master plan is even more important to ensure objective assessment.  Because there is not much information available on the required content and development process the industry has many questions.

Key Questions related to risk management master plan are:

  • What are FDA requirements related to risk management and master plans?
  • What do we need a risk management master plan when we have a risk management plan for each project?
  • How to to define and start a risk management program?
  • How to ensure objectivity in risk assessment?
  • Who should develop a risk management master plan?
  • How to define type of risk categories and risk numbers?
  • Are there industry recommendations how to assign values to probability, severity and detectability?
  • Is there a good model available for a risk management master plan?

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 and examples. After the seminar, an extensive list of reference material like an example master plan, SOPs, worksheets and templates  will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • FDA/EU and ISO Requirements for risk management
  • Requirements of ICH and recommendations from PIC/S and GTFH
  • The importance of risk management plans and risk management master plans
  • Key differences between a risk management master and a project plan
  • Structure and contents of the risk management master plan
  • Streamlining the development process
  • Selecting and verification of the right model for risk management
  • Defining and documenting responsibilities
  • Setting the number of risk levels and ensuring objectivity across the company
  • Recommendations for severity, probabilities and risk priority numbers and for  residual risk numbers
  • Going through a complete example of an industry proven risk management master plan (also available as hand-out)

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

  • PowerPoint Presentation
  • Script
  • Risk Management Master Plan: 40 pages
  • 70-page Primer: Risk Management in the (Bio)Pharmaceutical and Device Industry
  • SOP: Risk assessment Used for GxP Environments
  • SOP: Risk-based Validation of Computer Systems
  • SOP: Risk-based Qualification of Network Infrastructure
  • SOP: Risk-based Validation of Laboratory Systems
  • SOP: Risk Assessment for Laboratory Systems
  • SOP: 21 CFR Part11 - Scope and Controls
  • Checklist: Risk Management for FDA and ICH Compliance
  • Case studies: Risk based methodologies for laboratory tasks
  • Requirements Related to Risk Management: FDA, EU, ICH, PIC/S, Others
  • Reference paper: Risk-based Validation of Off-the-shelf Computer Systems
  • ICH Risk Management Guide
  • NIST Guide: Risk Management for IT Systems
  • Risk Management Guide of the Global Harmonization Task Force (GHFT)

Who should attend?

  • Risk managers
  • Project managers
  • Regulatory affairs
  • QA managers and personnel
  • Analysts and lab managers
  • Validation specialists
  • Documentation professionals
  • 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.