Speaker Profile


Dr. Ludwig Huber

Director , Labcompliance

Ludwig Huber Ph.D., is the director and editor of Labcompliance 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". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. For more information, please visit Dr. Huber’s website www.ludwig-huber.com

  •  Monday, October 22, 2018
  • 10:00 AM PDT | 01:00 PM EDT,
  • 75 Minutes
  • ¤150.00
Understanding the USP Chapter 1224 for Transfer of Analytical Methods

When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

  •  Tuesday, November 6, 2018
  • 10:00 AM PST | 01:00 PM EST,
  • 75 Minutes
  • ¤150.00
Validation of Analytical Methods and Procedures

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 and accreditation standards such as ISO 17025 since many years and new official guidelines have been published by FDA, EMA and USP in the last 4 years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.

  •  Tuesday, November 20, 2018
  • 10:00 AM PST | 01:00 PM EST,
  • 75 Minutes
  • ¤150.00
FDA's New Enforcement of 21 CFR Part 11

FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.

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  • Recorded
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  • 75 Minutes
  • ¤189.00
FDA Compliant HPLC Qualification and Performance Testing

High Performance Liquid Chromatography is the most frequently used analytical tool for pharmaceutical and API testing laboratories. FDA and international agencies require HPLC equipment to be calibrated, qualified and tested to ensure accurate and reliable analytical results. Even though this is well known since long time, laboratories are unsure on what exactly should be tested initially and on an on-going basis.

  • Recorded
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  • 2 Hours
  • ¤189.00
Quality by Design (QbD) for Development and Validation of Analytical Methods

Using the QbD approach for development and validation will result in more robust analytical methods. Advantages are easier method transfer, longer revalidation cycles and fewer or no methods specific Out-of-Specification situations when used in routine.

  • Recorded
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  • 75 Minutes
  • ¤178.00
Auditing Computer Systems for FDA and International Compliance

Auditing of computer systems is important to verify compliance of the systems with regulations and internal standards. When done right, audits can help to improve quality of computer system operation and uptime.

  • Recorded
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  • 75 Minutes
  • ¤183.00
Calibration and Qualification in Analytical Laboratories

Laboratory equipment should be calibrated and/or qualified to demonstrate suitability for the intended use. Laboratory systems including equipment are amongst key targets of FDA inspections. They are considered high risk systems because they have a high impact on product quality. Despite the fact that equipment calibration and qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify, test and document.

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