GLP Training

Good Laboratory Practices are prerequisites for any organization conducting a non-clinical study. In order to assure the regulatory Authorities that the data submitted is reliable and consistent with the obtained results during the study, GLP training is important. HORN Pharmaceutical Consulting is offering active and creative workshops that foster a collaborative environment of interest to both practitioners and researchers.

Our training programs are specifically designed to increase employee knowledge and broaden their experience in the area of GLP guidelines, specifications, and regulations.
After our training, all participants will have gained a fundamental understanding of the basis of the regulations, the necessity of rigorously implementing them, monitoring compliance and pro-active thinking in all scientific matters. This way the risk of non-compliance and delays in the approval process can be minimized.

In-house Training

The ability to have your specific concerns addressed and discussed is one of the most important factors in any educational program. All training courses will be adapted to your requirements and your target group and - if necessary - designed completely from scratch. After all, they have to be suited to your individual situation and provide your company with recognisable added value.

Services

Our GLP training covers but is not restricted to the following topics:
  • GLP-requirements (EU, US)
  • Product safety testing
  • Development and training of Standard Operating Procedures (SOPs)
  • Preparation and conduct of inspections (FDA, EMA, national supervisory Authorities)
  • Quality Control (QC) and Quality Assurance (QA) Systems
  • Analytical and laboratory validation and compliance programs
  • Inspection of facilities and processes
  • Performance of inspections of in-life phases
  • Audit of final reports

HOTLINE

Phone +49 (0) 7251/305 529
Fax +49 (0) 7251/305 528
Mail

Events

  • 26.-27.02.2019
    Mannheim: GMP-gerechter Prozess-Transfer
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  • 19.-20.03.2019
    Prague: How to write the Quality Part of an IMPD
    More
  • 26.-27.03.2019
    Copenhagen: Handling Changes and Variations
    More
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News

  • 10.03.2017
    News for the Industry
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  • 26.07.2013
    News on Change Control/Variations:
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  • 31.01.2013
    EU: Revised GMP-Annex 2 published - Details defined for biological products including ATMPs
    More
Get all news
EU: New Variation System in force as of Jan 1, 2010. Filing of variations will be faster, easier, and more flexible. Have you considered that your Change Control System needs to be updated accordingly?
EU: Centralised Marketing Authorisation Procedure for ATMPs needed Have you already filed your application? The time clock is ticking. Transitional periods will be over soon.
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