With support:
Ministry of Industry and Trade Eurasian Economic Union FSI «SID & GP» SKOPINFARM LTD.

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Professional development course
Manufacturing sterile pharmaceuticals: focus on good practices
Duration:

72 ac. hours

Terms of study:

3 weeks

Cost of education:

Clarify ₽

Course information:
Training start date of the nearest stream -

The minimum number of students required to run the course: 10 Discounts available for organized groups of three or more students .
For more information, please call +7 (495) 676-43-12
Course authors:

  • Anton Avramenko
    Candidate of Pharmaceutical Sciences, Head of GMP, Education & Training Department, EAGP
  • Lyudmila Guzevatykh
    Doctor of Biological Sciences, Head of GMP Toxicology, R-Pharm
  • Assoc. Prof. Vladislav Sepp
    Candidate of Pharmaceutical Sciences, Senior Lecturer, Pharmacy Department, Pirogov Russian National Research Medical University
  • Prof. Boris Sysuev
    Doctor of Pharmaceutical Sciences, Head of Pharmaceutical Development & Innovative Dosage Form Center, Sechenov First Moscow State Medical University
  • Oleg Nekrasov
    CEO of Legispharm
  • Alexander Belinsky
    Lead Specialist, Qualification, PQE Group
  • Oleg Spitsky
    Head of QS, Biopharmproject
  • Assoc. Prof. Konstantin Koshechkin
    Doctor of Pharmaceutical Sciences, Senior Lecturer, Information & Internet Technology Department, Digital Medicine Institute, Sechenov First Moscow State Medical University
  • Kirill Futysh
    Head of Validation, Generium Next
  • Ekaterina Rastoltseva
    Quality Director, Servier Russia
  • Margarita Golobokova
    Expert in microbiology
  • Alexey Kovrigin
    Director for Licensing & GxP Assessment, Valenta Pharm
Target audience and learning outcomes:

  • The course is designed for employees of pharmaceutical manufacturing facilities and related units, whose jobs have an impact on the quality of sterile pharmaceuticals
  • Out of all pharmaceutical products, patient safety risks linked to deviations in the quality of sterile pharmaceuticals are justifiably the highest, subject to pharmaceutical inspectorate’s close scrutiny
  • The course is based on such principles as continuous risk management approach to product lifecycle, and consolidation of risk knowledge and its transfer to the next stages in the quality of the monitored item. It is also built on the premise that in mass production, all accumulated knowledge should be used consistently and effectively right at the production site, to make sure the product meets the required quality standards
  • The course is taught by the industry’s leading experts with exceptional expertise in sterile pharmaceuticals, including R&D, registration, engineering, design, manufacturing and QC
  • The curriculum helps acquire comprehensive knowledge, including theoretical part, regulations, recommendations and case studies
Designed for:

  • Authorized persons of pharmaceutical companies
  • Employees participating in audits and self-inspections of pharmaceutical production facilities
  • Employees of industry departments and organizations
Minimum qualification requirements:

University or vocational degree

Credit hours:

72 academic hours

Mode of study:

Extramural, distance-learning

Duration:

3 weeks


Document to be issued:

Upon graduation, according to Federal Law 273-FZ "On Education in the Russian Federation", students are issued certificate of professional development of the established sample.

Presentation of the certificate:

The certificate can be presented to the listener personally, for this you must first to enroll by contacting the Academy by phone or e-mail.


If there is no possibility of personal receipt, the certificate will be sent by the delivery service documents with a tracking number assigned (delivery is free).

Contact information: E-mail: info@gxp-academy.org Phone: +7 (495) 676-43-12

Register to Advanced Training

Manufacturing sterile pharmaceuticals: focus on good practices


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