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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.

On-line Audio Seminar 135

FDA/EU Compliance in Analytical Laboratories

Requirements and Tools for Implementation

Recorded

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Analytical laboratories are considered high risk systems. Typically they perform the last control step before products are released. Therefore laboratory systems are on the radar screen of FDA and other inspections. According to the FDA inspection results 2004/05 the number of deviations found in laboratory systems come right after the quality system. For example inadequate equipment calibration, maintenance, method validation and inadequate failure investigations, and corrective and preventive actions are amongst the most frequently cited deviations. Although FDA and EU regulationshave been around since a long time, laboratories still struggle with effective implementation.

Key Questions related to compliance in analytical laboratories are:

  1. What do FDA and other regulations require for analytical laboratories?
  2. What exactly are the most frequently found inspection deviations and how to avoid them?
  3. How to develop an efficient compliance program for laboratories?
  4. How can risk assessment help to comply in a more efficient manner?
  5. How to develop a training plan?
  6. Which written procedures are required and how to write them?
  7. How to validate analytical methods?
  8. How to validate software and computer systems ?
  9. How to handle failure investigations and out-of-specification results?
  10. Which data should be recorded, for how long and in which form?

How does the audio seminar help:

Answers will be 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. Because of the nature of this seminar it is most important to point to useful references that will be made available for the seminar. More than 15 documents such as SOPs, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • FDA regulations and guidelines
  • FDA inspection and enforcement practices
  • Most frequently cited deviations. Recommendations on how to avoid them.
  • Developing and implementing a validation master plan
  • Qualification of analytical equipment and computers
  • Sample handling and qualification of chemicals
  • Validation of analytical methods and procedures
  • Developing an FDA compliant training plan
  • Writing FDA compliant procedures
  • Managing failure investigations and OOS results
  • Maintenance and archiving of paper and e-records
  • Preparation for FDA inspection

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

  • SOPs:
    - Handling OOS results
    - Laboratory Failure Investigations
    - Validation of Laboratory Computer Systems
    - Validation of Chromatographic Methods
    - Qualification of Equipment
    - Validation of Electronic Laboratory Notebooks
    - Validation of Spreadsheet Applications
    - Change control of analytical equipment
    - Development and Maintenance of Test Scripts for Analytical Equipment
  • Worksheets/Checklists/Examples
    - Laboratory Audits
  • Reference Articles
    - Implementing 21 CFR Part 11 in Laboratories
    - Preventing Out-of-Specification Situations Caused by Laboratory Errors
    - Selecting parameters and limits for equipment qualification
    - Preparation and qualification of (certified) reference material and working standards
  • FDA Presentations and Reports
    - Laboratory inspections
    - 2004/05 FDA Inspection report
    - Drug cGMP Requirements for Laboratory Records
    - Selecting Parameters and Limits for Equipment Operational Qualification
  • Five Warning letters and/or Inspectional observations related to Analytical Laboratories
  • FDA Guidance for Industry:
    Inspection of Quality Control 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

How to order

Replaced by the more recent seminar

FDA/EU cGMP Compliance for Laboratories

Requirements and Tools for Implementation

Click here

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.