Speaker Profile

Dr. Ludwig
Dr. Ludwig Huber
Director,

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

Upcoming Webinars Recorded Webinars
  • 14
  • April
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Dr. Ludwig Huber Dr. Ludwig Huber | Duration:75 Minutes | Price: $149.00 | View Details
  • 16
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

2-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11

FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.

Dr. Ludwig Huber Dr. Ludwig Huber | Duration:2 Hours | Price: $199.00 | View Details
  • 23
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

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.

Dr. Ludwig Huber Dr. Ludwig Huber | Duration:75 Minutes | Price: $149.00 | View Details
  • 28
  • April
  • 2021
  • Wednesday
10:00 AM PDT | 01:00 PM EDT

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.

Dr. Ludwig Huber Dr. Ludwig Huber | Duration:75 Minutes | Price: $149.00 | View Details
  • 30
  • April
  • 2021
  • Friday
10:00 AM PDT | 01:00 PM EDT

3-Hour Virtual Seminar on Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA-EMA, USP and ICH

The 3-hour virtual seminar will give attendees the background to understand the requirements and even more importantly it will focus on strategies and provide tools to implement even most critical requirements.

Dr. Ludwig Huber Dr. Ludwig Huber | Duration:3 Hours | Price: $299.00 | View Details
Dr. Ludwig Huber

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.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $199.00 | View Details
Dr. Ludwig Huber

2-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11

FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 2 Hours | Price: $249.00 | View Details
Dr. Ludwig Huber

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.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $199.00 | View Details
Dr. Ludwig Huber

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.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $199.00 | View Details
Dr. Ludwig Huber

3-Hour Virtual Seminar on Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA-EMA, USP and ICH

The 3-hour virtual seminar will give attendees the background to understand the requirements and even more importantly it will focus on strategies and provide tools to implement even most critical requirements.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 3 Hours | Price: $349.00 | View Details
Dr. Ludwig Huber

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.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $399.00 | View Details
Dr. Ludwig Huber

2-Hour Virtual Seminar on FDA's New Enforcement of 21 CFR Part 11

FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 2 Hours | Price: $449.00 | View Details
Dr. Ludwig Huber

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.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $399.00 | View Details
Dr. Ludwig Huber

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.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 75 Minutes | Price: $399.00 | View Details
Dr. Ludwig Huber

3-Hour Virtual Seminar on Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA-EMA, USP and ICH

The 3-hour virtual seminar will give attendees the background to understand the requirements and even more importantly it will focus on strategies and provide tools to implement even most critical requirements.

Speaker: Dr. Ludwig Huber | View Anytime | Duration: 3 Hours | Price: $549.00 | View Details