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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 137

FDA Compliant Testing for Validation and Qualification

What - How Much - How to Document

Recorded

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Initial and on-going testing is the most time consuming part in the overall validation/qualification of equipment and processes. Correct planning, execution and documentation is key for FDA inspections. Validation professionals, QA staff and users often are not sure what to test, how to develop test scripts, how to conduct tests and how to document validation or qualification tests.

Key Questions related to test scripts and validation protocols are:

  • What do FDA and other regulations say about testing, test scripts and validation protocols?
  • What exactly are the expectations of inspectors?
  • What should be tested for processes?
  • What should be tested for equipment: hardware, operating systems, firmware and application software?
  • How to apply risk based testing
  • How to develop efficient FDA compliant test scripts?
  • The FDA expects quantitative testing, what does this mean?
  • How much detail do we need to test and document?
  • When do I need qualification protocols versus test scripts?
  • Are test scripts 'official' documents?
  • Who writes test scripts for computers: QA, IT or Operations?
  • How to document execution of tests (screen captures, printouts, video)
  • Who signs and approves test scripts?
  • Can we use automated test tools?
  • Who reviews test results: QA, IT, Operations?
  • For how long should test scripts and qualification protocols be archived?
  • What should vendors provide?

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. After the seminar, an extensive list of reference material like SOPs, templates and test script examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • Business and FDA requirements for testing
  • Recommendations from GAMP
  • Developing a test plan
  • Risk based testing
  • Developing an SOP for FDA compliant test scripts
  • Developing templates for test scripts
  • The importance of a traceability matrix
  • Quantitative vs. qualitative testing
  • Testing equipment hardware
  • Testing of commercial systems
  • Using automated test tools
  • Leveraging supplier testing
  • Recording and documentation of test execution (screen captures, print outs etc)
  • Handling errors and deviations
  • Review and approval of test scripts and qualification protocols
  • Maintaining and archiving test protocols and reports
  • Gong through examples: instrumentation, Excel spreadsheet, network devices

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

  • Zip file with 10 examples/templates for testing: schedule, test protocols, traceability matrix, test summary.
  • SOP: Qualification of equipment (with test templates)
  • SOP: Testing file integrity of e-mail attachments
  • Reference Paper:: Selecting parameters and limits for equipment operational qualification
  • SOP: Revalidation of software and computer systems
  • Test protocol for an Excel™ application (29 pages with test plan, traceability matrix, test summary report and examples for functional testing)
  • Templates and example: Test protocol - Authorized System testing
  • Warning letters and Inspectional observations related to testing.
  • FDA guidance on validation and qualification.

Who should attend?

  • QA managers and personnel
  • Operations managers
  • Users of equipment, software, computer systems, networks
  • Validation specialists
  • IT-staff
  • Training departments
  • Documentation department
  • Consultants

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.