FSI «SID & GP»
The Ministry of industry and trade of the Russian Federation
+7 (495) 676-43-60 109044, Moscow, Lavrov lane., 6

“Solidarity training program”: uniting pharmaceutical industry and the world

The year 2021 has already been quite active for “Solidarity training program” under a joint program of supporting the implementation of best practice cases in the Russian pharmaceutical sphere, which was initiated by FSI “SID & GP” and Pharmstrategiya LLC. This year the project organizers are planning to conduct educational webinar on a weekly basis. As of now, the webinar program has been formed for the whole first half of the year.

Although webinars that were held in January touched upon different issues related to pharmaceutical manufacturing, regulator’s perspective, and also the use of the industry’s best experts in their capacity as experts. The webinar’s clients within project within “Solidarity training program” were companies named FRESENIUS KABI and INFAMED K, and they allow all interested pharmaceutical specialists to join webinar on a no-cost basis, thanks to the realization of shared principle of “open doors”.

There were more than 1300 listeners in the January webinar and included people from the Eurasian Economic Union member-states, CIS countries, European states, Nicaragua, UAE and USA. Wide and increasing outreach is attributable to the relevance of the webinar’s topics, proactive engagement on behalf of the industry with respect to receiving the information from experts and representatives from a regulator. And the use of modern communication techniques and conducting seminar online as part of the realization of principles of “Solidarity program” provides the opportunity for exchanging perspectives and enhance knowledge not only for specialists of the enterprises from the capital, but also for regional and foreign colleagues.

For FRESENIUS KABI webinars were organized on 15 and 22 January on topics “Transition to Eurasian GMP rules”. Risk-based approach in relation to water preparation system: normative framework and regulatory expectations” and “Application of risk-based approach to studying the stability of drugs and API in the light of latest changes in the normative documentation”. Within the first webinar, regulatory requirements for quality indicators and methods of obtaining water used for the pharmaceutical needs were reviewed, and the issue pertinent to the introduction of novelties into regulatory requirements and relevant changes in approaches to organization and exploitation of water preparation systems on the pharmaceutical enterprises were also discussed. On the webinar on stability, clear answers were given to the questions related to the application of risk-based approach whilst studying stability, the documentation of the risk analysis and regulatory requirements and inspectorate’s expectations were examined in depth.

“The program covered the issues in depth and professional manner, in relation to the topic concerned. Plenty of useful information, which was analyzed and presented in an accessible format, – shares her impressions Registration manager of FRESENIUS KABI, Anna Orishchenko. – I would like to highlight an excellent organization and also speaking experts, who were presenting during the webinar and were willing to give detailed answers to all the posed questions”.

On January, 29 a webinar for INFAMED K was organized on the subject “System of corrective and preventative actions”. Evaluation of effectiveness», in which experts made a presentation on the degree to which quality-related problems can be identified and resolved during the implementation of CAPA system in the enterprise; experts also held a

discussion on how to organize the enterprise’s work correctly with CAPA, how to use non-conformities identified during inspections for mapping out CAPA and improving quality of a manufacturing site. Please visit https://gilsinp.ru and https://www.goodpractices.ru to know the timetable and topics for webinars, organized by FSI “SID & GP” and LLC “FARMSTRATEGIYA”.

To request and clarify the terms of participation, please phone +7 (985) 115-77-88 or e-mail at: gmp-seminars@pharmstg.ru

The information webinar partners of FSI “SID & GP” and LLC “FARMSTRATEGIYA” are Pharmaceutical vestnik, portals Medvestnik and GxP News.