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, April 30, 2018
  • 10:00 AM PDT | 01:00 PM EDT,
  • 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.

  •  Thursday, May 3, 2018
  • 10:00 AM PDT | 01:00 PM EDT,
  • 75 Minutes
  • ¤150.00
Understanding and Implementing USP 1058 Analytical Instrument Qualification

This webinar will discuss all details and give strategies and case studies for easy implementation. The first version of USP <1058> has been released in 2008. Since then it has evolved to the global standard for analytical instrument qualification. In August 2017 a new revision has been released with many new requirements mainly addressing the needs of quality systems, e.g., risk based implementation, quality agreements between service/system providers and users, and regular reviews to ensure ongoing performance and more.

  •  Monday, May 14, 2018
  • 10:00 AM PDT | 01:00 PM EDT,
  • 75 Minutes
  • ¤150.00
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

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  • Recorded
  • View Anytime
  • 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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