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Dr.Ludwig Huber
Area Of Expertise : Validation
20 Years Of Experience
Training Industry : Life Sciences
Dr. Ludwig Huber, Ph.D., is the chief advisor and editor of www.labcompliance.com the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare, and of the 70-page primer: Validation of Analytical Methods".
He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China CFDA, ISPE, PDA, PIC/S and several other industry organizations and national health care agencies.
Dr. Huber has been awarded as
• The Presenter of the year at IVT conferences, selected by thousands of attendee as #1 out of 175 presenters
• The Winner of the "First International GLP Award" from Indian Drug Manufacturer Association for Publications and Presentations in the Area of GLP and GMP
• Winner of the Wallhaeusser award, sponsored by the European Compliance Academy for publications in the area of 'Quality and Safety of Drugs'
3 results Found
Recorded Webinar
Validation of Laboratory Instruments and systems
Laboratory equipment and systems should be validated to demonstrate suitability for the intended use. Laboratory systems including equipment and computer systems are amongst key targets of FDA inspections. They are considered high risk because when used to co ...
- Intermediate
- 75 Mins
Recorded Webinar
Using Excel for FDA Compliance
Excel® Applications are widely used in laboratories, offices and manufacturing e.g.,for data capture,data evaluation and report generation. Regulations such as FDA's GxPs and 21 CFR Part 11 require users of software and computer systems to demonstrate and document da ...
- Intermediate
- 75 Mins
Recorded Webinar
Validation, Verification and Transfer of Analytical methods and Procedures
Analytical methods and procedures should be validated to ensure reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transfer ...
- Intermediate
- 180 Mins