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Qualification and Offerings of Dr. Ludwig Huber as Trainer

Contact Info

  • Name and address
    Ludwig Huber, Ph.D, Obere Alm 27, Oberkirch 77704, Germany
  • Phone
    +49 7802 980582
  • E-mail
    ludwig_huber@labcompliance.com

Type of training offerings

  • Public audio/web seminars: duration 1 to 4 hours
  • Private audio/web seminars for individual companies. duration 2 to 4 hours
  • Presentations and chairman at public conferences
  • In person workshops/seminars at public conferences: duration 1 to 3 days
  • In person workshops/seminars for private companies: duration 1 to 3 days

Subject of trainings

  • Good manufacturing practices
  • GMP for quality control and contract laboratories
  • Validation, verification and transfer of analytical methods
  • Development and validation of stability indicating methods
  • Part 11 compliance in QC and Contract  laboratories
  • Handling out of specification (OOS) and out of trend (OOT) results
  • Qualification/calibration of analytical equipment according to USP <1058>
  • Risk assessment for laboratories
  • Good laboratory practices
  • Quality systems for Laboratories
  • ISO/IEC 17025 accreditation
  • Part 11 / EU Annex 11 compliance of computer systems and records
  • Ensuring integrity and security of laboratory records
  • Documentation management for GxP compliance
  • Computer system validation according to GAMP
  • Validation and use of Excel spreadsheets in regulated environments
  • Network qualification
  • FDA inspection and enforcement practices: Recent examples of Warning Letters

Experience with presenting at conferences/seminars organized by agencies

  • US FDA
  • China CFDA (previous SFDA)
  • China National Institute for Food and Drug Control (NIFDC)
  • Singapore HSA
  • Korea KFDA
  • Thai Ministry of Health and Welfare
  • PIC/S (Pharmaceutical Inspection Convention and Cooperation Scheme)

Experience with conferences/seminars organized by industry task forces

  • International Society for Pharmaceutical Engineering (ISPE)
  • Good Automated  Manufacturing Practice Forum (GAMP)
  • Parenteral Drug Association (PDA)

Experience with presenting at public conference providers

  • Institute of Validation and Technology
  • CBI Conferences
  • Advanstar Communications
  • ComplianceOnline
  • GlobalComplincePanel
  • FDA News
  • FX Conferences
  • Analytica China
  • Analytica Vietnam
  • Anakon India
  • Institute for International Research (IIR)
  • Barnett International
  • Pharmaceutical Consultancy Service (PCS)
  • Concept Heidelberg
  • European Compliance Academy
  • SMI Pharmaceutical Conferences
  • Business Intelligence Conference
  • Pharmaceutical Training Service (PTS)
  • IBC Life Science Division

Awards

  • Presenter of the year at IVT conferences, selected by thousands of attendee as #1 out of 175 presenters
  • Winner of the "First International GLP Award" from Indian Drug Manufacturer Association for Publications and Presentations in the Area of GLP and GMP
  • Winner of the Wallhaeusser award, sponsored by the European Compliance Academy for award for publications in the area of 'Quality and Safety of Drugs'  

Text Books and other publications

  • Validation of Computerized Analytical Systems",  Interpharm Press, 1995
  • "Validation and Qualification in Analytical Laboratories", Interpharm Press, 1998, 2007
  • "Validation of Computerized Analytical and Networked Systems", Interpharm Press, 2002
  • GLP and cGMP in Analytical Laboratories, Agilent Technologies, 2001
  • Labcompliance Best Practices: "Network Quality Package" and "Validation Master Plan"
  • Labcompliance Best Practices "Macro and Spreadsheet Quality Package"
  • Labcompliance Best Practices "FDA Inspections" and "Risk Management Master Plan"
  • "GLP and cGMP in Analytical Laboratories", with more than 130 000 copies distributed
  • More than 100 literature publications related to pharmaceutical analysis and validation&compliance

Member of Task Forces (past or current)

  • Member of the US PDA task force on 21 CFR Part11,
  • Member of the GAMP America, special interest group: lab computer systems
  • Member of IVT task force 2003: IT Infrastructure&Network Qualification
  • Member of scientific advisory board of IVT's GxP Journal
  • Board member of 21CFRPart11 Compliance - Newsletter
  • Board member of Pharmaceutical Technology Europe
  • Member of the advisory board for the European Compliance Academy (ECA)
  • Input and review team of FDA internal SOPs
  • Input and review team of FDA internal Lab Information Bulletins (LIS)

Education

  • 1975: Master of Science in Chemistry at University of Karlsruhe, Germany
  • 1978: PhD in Chemical engineering at University of Karlsruhe, Germany

Job experience

  • 2008 - today
    Consulting and training of pharmaceutical industry and testing laboratories on validation and compliance for more than 20 years
  • 1978 - 1983:
    Applications Chemist of Gas and Liquid Chromatography at Hewlett Packard
  • 1983 - 2000
    Product manager for HPLC modules and systems at Hewlett-Packard
  • 1985 - 1988
    Industry manager for environmental and food applications at Hewlett-Packard
  • 1988 - 1995
    Industry manager for (bio)pharmaceutical applications at Hewlett-Packard
  • 1995 - 2000
    FDA compliance program manager at Hewlett-Packard
  • 2000 - 2008
    Product and Marketing Manager for various analytical and data systems targeted to pharmaceutical industry at Agilent Technologies
  • 2000 - 2008
    FDA Compliance Master at Agilent Technologies
  • 2008 - today
    Director of Labcompliance, the global resource for validation and compliance

Contact Info

  • Name and address
    Ludwig Huber, PhD, Obere Alm 27, Oberkirch 77704, Germany
  • Phone
    +49 7802 980582
  • E-mail
    ludwig_huber@labcompliance.com

Examples for Interactive Trainings and ┬┤Workshops

Testimonials - Feedback on Ludwig Huber's trainings

More than 100 testimonials have been received through the feedback forms to Ludwig Huber's  seminars and Compliance packages. The authors agreed to publish them. All information on the submitters of the testimonials can be reviewed in the Labcompliance archive. For examples, click here

 

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