ComplianceOnline

Expert Profile


Dr. Ludwig Huber
Director and Chief Editor, Labcompliance

Dr. 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 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.

Trainings by Expert

Understanding and Implementing USP <1058>: Analytical Instrument Qualification
Category: All FDA Regulated Industry , FDA Validation , Documentation and IT , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations

Change Control for Computer Systems - strategies and tools for FDA compliance
Category: Drugs and Chemicals (Pharma) , Medical Devices , IT control and PCI compliance , Biotechnology , All FDA Regulated Industry , Documentation and IT , Laboratory , Documentation and Policy Management , Lifescience process & Procedures , Life Sciences , Documentation and Data Management

Master Planning for Computer System Validation
Category: Medical Devices , IT control and PCI compliance , All FDA Regulated Industry , FDA Validation , Life Sciences

Managing Failure Investigations and OOS Situations - Regulatory Requirements and Strategies for Implementation
Category: Medical Devices , All FDA Regulated Industry , FDA Audit and Inspection , Life Sciences

Effective Training for FDA Compliance: What to train - How much to Train - How to Document Effectiveness
Category: Medical Devices , All FDA Regulated Industry , FDA 21 CFR Part 11 , Life Sciences

Validation of Analytical Methods and Procedures - Design, Conduct and Document for Efficiency and Compliance
Category: All FDA Regulated Industry , FDA Validation , Testing and Validation , Laboratory , Analytical Laboratory , Documentation and Policy Management , Lifescience process & Procedures , Life Sciences , Documentation and Data Management

Good Laboratory Practice Regulations
Category: Drugs and Chemicals (Pharma) , Medical Devices , Laboratory Compliance , All FDA Regulated Industry , FDA 21 CFR Part 11 , Life Sciences

Validation of Computerized Analytical Systems
Category: Drugs and Chemicals (Pharma) , Medical Devices , IT control and PCI compliance , Clinical Research , Biotechnology , All FDA Regulated Industry , Testing and Validation , Documentation and IT , Laboratory , Analytical Laboratory , Best practices , Life Sciences , Documentation and Data Management , IT

Microsoft Word and Excel in FDA Regulated Industries: Pack of Four Training Courses
Category: Drugs and Chemicals (Pharma) , Medical Devices , Documentation Manager , All FDA Regulated Industry

Risk Based Validation of Software and Computer Systems
Category: Risk Management , All FDA Regulated Industry , FDA Validation , Documentation and IT , Risk Management & Controls , All FDA Regulated Functions , Life Sciences