Dr. Ludwig Huber
Dr. Ludwig Huber
Ludwig Huber, Ph.D., is the director of Labcompliance 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”. He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11, 21CFR Part 111 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies. For more information, please visit Dr.Huber’s website (www.ludwig-huber.com).
-
How to Prepare Yourself for FDA’s on-going Part 11 Inspection Program
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... -
Validation and Control of Excel® Spreadsheets in Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA’s GxP and 21 CFR Part 11 require users of software and... -
How to Prepare Yourself for FDA’s on-going Part 11 Inspection Program
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... -
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 violations. Citations are related to inadequate integrity, security... -
Auditing Computer Systems for FDA and International Compliance
With new guidelines and requirements in place the focus of both FDA and international inspections is shifting shift more and more to computer systems and Electronic records. An example is the new EU Annex 11 with requirements for periodic... -
Sampling and Sample Handling in Laboratories
Sampling is an important operation within the entire analytical testing process in which only a small fraction of a product is taken. Valid conclusions on the whole test can only be based on representative sampling. Thorough handling of samples... -
Validation and Control of Excel® Spreadsheets in Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA’s GxP and 21 CFR Part 11 require users of software and... -
System Suitability Testing (SST) for USP and FDA Compliance
System suitability testing (SST) is required by USP, FDA and EP to check and ensure on-going performance of an analytical systems and methods. Both USP and EP have chapters with recommendations for system suitability tests that are enforced by... -
Auditing Computer Systems for FDA and International Compliance
With new guidelines and requirements in place the focus of both FDA and international inspections is shifting shift more and more to computer systems and Electronic records. An example is the new EU Annex 11 with requirements for periodic... -
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 violations. Citations are related to inadequate integrity, security... -
Ensuring Integrity and Security of Laboratory Data for FDA / EU Compliance
This webinar will provide a comprehensive understanding of the key FDA/EU requirements for integrity and security of laboratory data and offer recommendations and tools for effective implementation. The FDA has found and reported multiple cases where companies manipulated electronic... -
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... -
Computer System Validation: Step-by-Step
The validation of computer system has been an FDA requirement since more than 20 years. Nevertheless companies have problems with implementation. This is proven through many FDA warning letters related to software and computer system validation, especially in the... -
Ensuring Integrity and Security of Laboratory Data for FDA / EU Compliance
This webinar will provide a comprehensive understanding of the key FDA/EU requirements for integrity and security of laboratory data and offer recommendations and tools for effective implementation. The FDA has found and reported multiple cases where companies manipulated electronic... -
Sale!
Understanding the Final FDA Guidance for Validation of Analytical Methods
Recently the FDA has released a new comprehensive guidance for validation of analytical methods. The guidance applies the modern integrated lifecycle approach with related new requirements for using quality-by-design components, risk assessment, design space and continuous improvement. The guidance... -
GLP Regulations – Introduction and Strategies for Implementation
Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don’t know exactly what GLP really means, or what procedures are required and how to implement GLP regulations. Lack of GLP... -
Sale!
How to Prepare Yourself for FDA’s on-going Part 11 Inspection Program
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... -
Sale!
Validation and Use of Excel® Spreadsheets in Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA’s GxP and 21 CFR Part 11 require users of software and... -
Sale!
Comparing GLP with GMP
Good Laboratory and Good Manufacturing practices are regulations that are applied during different lifecycle phases of drugs and drug substances. Both regulations have some common requirements but there are also significant differences. There are many questions about the differences... -
Transfer of Analytical Methods and Procedures according to USP 1224
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. For a long time there was no official guidance on what exactly is expected... -
Transfer of Analytical Methods and Procedures according to USP 1224
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. For a long time there was no official guidance on what exactly is expected... -
Validation and Use of Excel Spreadsheets in Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA’s GxP and 21 CFR Part 11 require users of software and... -
Effective Training Practices for FDA Compliance
No or inadequate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters. Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspectors. On the other... -
Risk Based Validation of Computer Systems and Part 11 Compliance
FDA and other agencies require to “Base software and computer validation and other controls of electronic records on a justified and documented risk assessment”. For example the PIC/S Guide on using computers states: “For GxP regulated applications it is... -
GLP Regulations – Introduction and Strategies for Implementation
Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don’t know exactly what GLP really means, or what procedures are required and how to implement GLP regulations. Lack of GLP... -
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 violations. Citations are related to inadequate integrity, security... -
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. In addition, FDA, USP... -
How to Prepare Yourself for FDA’s on-going Part 11 Inspection Program
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... -
GLP Regulations – Introduction and Strategies for Implementation
Description: Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don’t know exactly what GLP really means, or what procedures are required and how to implement GLP regulations. Lack of... -
FDA’s New Enforcement of 21 CFR Part 11
Description: 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 violations. Citations are related to inadequate integrity,... -
Quality by Design (QbD) for Development and Validation of Analytical Methods
Description: 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. In addition, FDA,... -
How to Prepare Yourself for FDA’s on-going Part 11 Inspection Program
Description: 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,... -
Validation of Analytical Methods according to the New FDA Guidance
Description: Recently the FDA has released a new comprehensive guidance for validation of analytical methods. The guidance applies the modern integrated lifecycle approach with related new requirements for using quality-by-design components, risk assessment, design space and continuous improvement. The... -
Ensuring Data Integrity for FDA/EU Compliance
Description: FDA has found and reported about multiple cases where companies manipulated electronic records. Since then FDA inspectors have focused inspections on security, availability, accuracy and integrity of ‘complete’ records. FDA has trained inspectors to identify data falsification and... -
Validation and Use of Excel® Spreadsheets in Regulated Environments
Description: Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA’s GxP and 21 CFR Part 11 require users of software... -
FDA’s New Enforcement of 21 CFR Part 11
Description: 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,... -
FDA’s New Enforcement of 21 CFR Part 11
Description: 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,... -
FDA’s New Enforcement of 21 CFR Part 11
Description: 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 violations. Citations are related to inadequate integrity,... -
GLP Regulations – Introduction and Strategies for Implementation
Description: Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don’t know exactly what GLP really means, or what procedures are required and how to implement GLP regulations. Lack of... -
Quality by Design (QbD) for Development and Validation of Analytical Methods
Description: 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. In addition, FDA,... -
How to Prepare Yourself for FDA’s on-going Part 11 Inspection Program
Description: 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,... -
Validation of Analytical Methods according to the New FDA Guidance
Description: Recently the FDA has released a new comprehensive guidance for validation of analytical methods. The guidance applies the modern integrated lifecycle approach with related new requirements for using quality-by-design components, risk assessment, design space and continuous improvement. The... -
Ensuring Data Integrity for FDA/EU Compliance
Description: FDA has found and reported about multiple cases where companies manipulated electronic records. Since then FDA inspectors have focused inspections on security, availability, accuracy and integrity of ‘complete’ records. FDA has trained inspectors to identify data falsification and... -
Validation and Use of Excel® Spreadsheets in Regulated Environments
Description: Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA’s GxP and 21 CFR Part 11 require users of software...
