GMP Training

Adherence to Good Manufacturing Practice requirements (cGMPs) is of utmost importance for pharmaceutical industry, as they produce and test products that are finally given to the patients. GMP requires that domestic or foreign manufacturers have an adequate quality system for the manufacture, testing, packaging, labelling and storage of medicinal products in place. This system should ensure that the drug products are adequately safe and effective for their intended use, and meet the required quality and purity characteristics.

The GMP training program is a mandatory requirement for personnel involved in manufacture, testing, storage and release of drug products. Adequate training will help your personnel to increase their competency and knowledge, and will avoid mistakes, failures and compliance risks. Constant training on latest GMP-requirements, new SOPs and inspection trends are important for the competency of your personnel.

Major emphasis of our GMP training courses is to give participants an introduction to cGMP as required according to national requirements. Please note that if you export drugs to US you need to comply with US-GMPs which differ from EU-GMPs. The focus is placed on understanding the need for and the intent of the various GMP-requirements and to develop mechanisms for implementation and compliance.

Those attending will also get an understanding of the needs for thorough and comprehensive training and documentation. We will make sure that your employees get the desired results.

Our courses are designed for all scientists (managerial and laboratory) and professionals in the pharmaceutical and biotechnology industry. Whether you are new to the pharmaceutical industry or you simply need refreshing training, HORN Pharmaceutical Consulting will consider your specific needs.

After our GMP 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

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

The GMP training course of HORN Pharmaceutical Consulting covers, but is not limited to the following areas:
  • Gain a thorough understanding of GMP-requirements (EU, US)
  • Development and training of Standard Operating Procedures (SOPs)
  • Preparation and conduct of inspections (FDA, EMA, national supervisory Authorities)
  • Quality control and Quality Assurance (QA) systems
  • Analytical and laboratory validation and compliance programs
  • Chemical production, i.e. production of Active Pharmaceutical Ingredients (APIs)
  • Pharmaceutical production
  • Storage and labelling

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
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  • 26.-27.03.2019
    Copenhagen: Handling Changes and Variations
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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
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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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