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

 

1. How much can you change an official methods before it isn't the official method any more 

2. Analytical method validation - A Regulatory Perspective

Verification of Compendial Procedures

Learn from FDA Warning Letters what inspectors look for and what mistakes other companies make so you can avoid them

 

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 293

Selecting Acceptance Criteria for Regulatory Method Validation

Learn through case studies and get inspection ready documentation

Recorded, available with all reference material at any time

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Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations since many years. Most often the theory is well understood and there is some official information from USP and ICH about parameters and test procedures. However there is hardly any such official information available for setting acceptance criteria. So the industry has lots of questions.

Key Questions related to Analytical Method Validation are:

  • What are FDA and international requirements?
  • Where can i find official acceptance criteria for method validation, method transfer and verification of compendial methods?
  • Which parameters must be evaluated for different applications, e.g., quantitative impurities in drugs, limit tests and assays
  • FDA requires methods to be suitable for their intended use: how to define, justify and document such suitability?
  • USP <1224> recommends comparative testing for method transfer, the type of and extend of tests should be based on risk, what does this mean in practice?
  • What are meaningful acceptance criteria for method transfer?
  • USP <1226> recommends to base the type and extend of test for verification of compendial methods on risk. what are acceptable tests and acceptance criteria?

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 go through several case studies for method validation, transfer of analytical methods and verification of compendial methods . After the seminar, an extensive list of reference material like SOPs, and inspection ready templates  are available to ensure immediate and cost effective implementation.

During the interactive presentation you learn about:

  • FDA and international requirements
  • Recommendations for parameters and test procedures from ICH and USP
  • Defining the minimum number of validation experiments that satisfy ICH, FDA and USP
  • Test conditions for method validation according to ICH Q2
  • Source data for test limits
  • Tests and acceptance criteria for transfer of analytical methods to comply with FDA: method must be suitable for it's intended use
  • Tests and acceptance criteria for verification of compendial methods  to comply with the FDA requirement: method must be suitable for it's intended use
  • Considerations for biological (large molecule based) drugs
  • Considerations for tests and acceptance criteria of biological and biosimilar drugs
  • Documenting and justification for FDA and other inspectors
  • Going through case studies
  • Using the inspection ready examples

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

  • SOPs
    - Setting Acceptance Criteria for Analytical Method Validation
    - Validation of Analytical Methods
    - Transfer of Analytical methods
    - Verification of Compendial Methods
    - Change versus Adjustment of Compendial Methods
  • Template/Checklist:
    - Validation of Analytical Methods
  • Example
    - Detailed Validation Report with test parameters, test procedures. acceptance criteria and actual results
  • Reference Articles
    - Validation of Analytical Methods: Review and Strategy
    - Validation of HPLC methods
  • Ten Warning letters and/or Inspectional observations related to method validation. transfer of analytical methods and verification of compendial methods
  • FDA Guidance and Policy:
    - Requesting Methods Validation for Abbreviated New Drug Applications
    - Bioanalytical Method Validation
    - Analytical Procedures and Methods Validation (draft)
  • FDA presentations on method validation
    - Analytical Methods Validation, A Regulatory Perspective
  • ICH Guidelines for the Industry Q2 (R1)
    - Text and Methodology on Validation of Analytical Procedures

How to define Acceptance Criteria

This table shows an example for test parameters and acceptance  limits for impurities in finished drugs by HPLC. Attend the Labcompliance seminar to see more examples and learn how to get and justify the limits.

 

Who should attend?

  • (Bio) Pharmaceutical and API Industry
  • Food, environmental, clinical, and chemical testing laboratories
  • QA managers and personnel
  • Analysts and lab managers
  • Validation specialists
  • Training departments
  • 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 a 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,