Speaker Profile
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
- 14
- April
- 2021
- Wednesday
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 |
Duration:75 Minutes |
Price: $149.00
| View Details
- 16
- April
- 2021
- Friday
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 |
Duration:2 Hours |
Price: $199.00
| View Details
- 23
- April
- 2021
- Friday
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 |
Duration:75 Minutes |
Price: $149.00
| View Details
- 28
- April
- 2021
- Wednesday
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 |
Duration:75 Minutes |
Price: $149.00
| View Details
- 30
- April
- 2021
- Friday
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 |
Duration:3 Hours |
Price: $299.00
| View Details
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
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
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
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
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
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
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
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
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
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