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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 309

Setting up a Quality System for Pharmaceutical Laboratories

Understanding and Implementing ICH Q10 and other Quality Systems

 Recorded, available with all reference material at any time

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Quality Systems are by far the most important systems as targeted by FDA during inspections. They are subject of each and every inspection and more than 50% of all FDA warning letters have citations related to quality systems. "No quality system and policy, no management reviews, no change control procedures, inadequate training procedures, deficiencies in complaint handling and internal and external audits" are just a few examples. However, the industry is unsure on which of the well known quality systems is the right one for pharmaceutical laboratories. Is it ISO 17025 which is established in all FDA laboratories and well known to FDA inspectors? Or is it ICH Q10 which is well known to the pharmaceutical industry but has no specificcs for laboratories? Or is it the FDA Guide on :"Quality Systems for Pharmaceutical manufacturing?". And the industry  has many other questions.

Key Questions related to Pharmaceutical Quality Systems are:

  • What are FDA and equivalent international requirements for Quality systems?
  • What are most frequent quality system citations in FDA warning letters?
  • When in the drug life cycle do we nee a quality system?
  • What quality systems are available for pharmaceutical laboratories?
  • What is the difference between ICH Q10 and ISO 17025?
  • How important is the FDA Guidance on Quality Systems for Pharmaceutical Manufacturing?
  • What are the big pharma companies doing?
  • Who is responsible for selecting and implementing quality systems?
  • What are the key elements of a quality system as defined in ICH Q10?
  • How to build an FDA compliant quality system from scratch?
  • How to implement a bullet proof quality system?
  • How can I lever
  • How to document a quality system?
  • How to audit or review a quality system in preparation for FDA inspections ?
  • age the quality system for less frequent and shorter FDA inspections?

How does the audio seminar help:

Answers to the questions above 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, checklists, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • Advantages of quality systems in pharmaceutcal laboratories
  • FDA requirements and expectations for quality systems
  • Most frequently cited deviations related to quality systems
  • Examples for quality systems
  • Similarity and differences of ICH Q10, ISO 17025 and FDA's Quality System Guide
  • Building up a quality system from ground
  • Developing SOPs for a quality system
  • The role of management, QA, IT, and operations
  • Most important elements of a quality system
  • The importance of risk management within a quality system
  • Cost effective step-by-step implementation
  • Leveraging the quality system for fewer and shorter FDA inspections
  • Leveraging the quality system for fewer FDA notifications after production changes
  • Maintaining a quality system or how to 'live' a quality system
  • Documenting a quality system for the FDA
  • Audit a pharma laboratory quality system in preparation for FDA inspections

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

  • SOP's:
    - Setting up a Quality System for Pharmaceutical Laboratories
    - Developing and maintenance of SOPs
    - Internal Audits - Preparation, Conduct, Follow-up
    - Conducting Management Reviews
    - Corrective and Preventive Actions
    - Training for Laboratory Personnel
    - Quality Assessment of Laboratory Suppliers
  • Gap Analysis/Checklist:
    - Pharmaceutical Quality Systems for Laboratories
  • FDA Inspection Reports
    - Establishment Inspection Report with 16 pages on quality systems
    - 483 with 15 inspectional observations related to quality systems
    - Five Warning letters with violations related to quality systems
  • FDA Guides
    - Guide to inspections of quality systems
    - Quality System for Pharmaceutical Manufacturing
  • ICH Guide Q10: Pharmceutical Quality Systems (including QC labs)

Who should attend?

  • Pharmaceutical, API and Device Manufacturers, Contract Laboratories, CROs
  • Laboratory managers and staff
  • QA managers and personnel
  • Regulatory affairs
  • 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 explained FDA's next 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,