Implementation of GxP at the enterprise: trainings, seminars
LDV Training Center, together with its European colleagues, provides consulting and training services to the companies that would like to improve their qualification and knowledge in the area of the GMP certification.
Training on the basic principles of GMP is an important yet most challenging step in establishing a "viable" system of Good Manufacturing Practice.
Our GMP trainings are aimed at both transferring theoretical and practical knowledge and increasing the motivation of the employees of the Customer to work within this system.
The proposed training is designed to maximize the knowledge and practical skills of each learner.
The main purpose of lectures and seminars carried out by LDV is to demonstrate the procedure of the GMP audit,
to introduce the process of documentation preparation and GMP procedures, to provide training for specialists of pharmaceutical companies,
to analyze production and quality control of medicinal products and others.
LDV Training Center organizes and delivers the following
as part of the professional educational programs
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Training workshops and sessions
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Training of specialists on a one-to-one basis
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On-site seminars
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Online training (webinars)
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List of topics for seminars and trainings for the companies that would like to work in accordance with the GMP Rules
- Manufacturing of sterile medicinal products (extended). Draft of the new version of Annex 1 of the GMP.
- Statistical methods in production and quality control of medicinal products.
- Organizational and technical and psychological aspects of preparation and conduct of audits in the area of GMP.
- Behavioral tactics in the process of GMP inspection: tips for manufacturers.
- Specific GMP requirements to the manufacturing of products made of herbal substances.
- Overview of the most important changes of the year 2015 to the EU GMPs with regard to premises, equipment and manufacturing process (GMP Sections 3 and 5).
- Overview of the new version of Annex 15 of EU GMP “Validation and Qualification”.
- New regulatory requirements to excipients. Analysis and specifics of the new “Formalized risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use” Guidelines.
- Good Distribution Practice of Active Pharmaceutical Ingredients - overview of new regulatory requirements.
- Practical training on the evaluation of risks of excipients used in the production of finished medicinal products for medical use, as well as ascertaining the appropriate good manufacturing practice with regard to the manufacturers of these excipients.
- Specific GMP requirements to the manufacturing of products made of herbal substances.
- New regulatory requirements to excipients. Analysis and specifics of the new “Formalized risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use” Guidelines.
- Good Distribution Practice of Active Pharmaceutical Ingredients - overview of new regulatory requirements.
- Innovative approaches in the pharmaceutical production: process analytical technology.
- Practical training on the prevention of risks of cross contamination in combined (multi-product) production.
- Practical training on the classification of typical GMP non-conformities.
- Overview of recent changes to Chapter 6 “Quality Control” of the EU GMP.
- Verification, adaptation and transfer of analytical methods (detailed analysis of new regulatory requirements of the EU GMP).
- Claims and product recall - new concept in Section 8 of the RU GMP and its discussion.
- Overview of the most important changes of the year 2015 to the EU GMPs with regard to premises, equipment and manufacturing process (GMP Sections 3 and 5).
- Identification of risks in the manufacture of different medicinal products in shared facilities based on the evaluation of health based exposure limits - new regulatory requirements.
- Evaluation of risks of cross contamination in the manufacture of products in shared facilities (including overview of the ISPE Risk МаРР document).
- Validation of cleaning in combined (multi-product) production. New criteria for cleaning based on health impact assessment. Comparison of criteria in theory and in practice.
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Practical seminars
Practical seminars are held both in our Center in Moscow and at the enterprises of the customers.
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Schedule, dates and location
Schedule dates and location for seminars are agreed upon with the customer.
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Number of participants
Maximum number of participants of the seminar - 14.
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Contact Us
125212, RF, Moscow, BC "Vodny", Golovinskoye sh., 5,
corp. 1, 14th floor, office. 14014
corp. 1, 14th floor, office. 14014