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

RU EN
Professional qualification course
Pharmaceutical auditor training
Duration:

72 ac. hours

Terms of study:

3 weeks

Cost of education:

Clarify ₽

Course information:
Start date: October 2024.

Discounts available for organized groups of three or more students.
For more information, please call +7 (495) 676-43-12

Course authors:

  • Tatyana Nikolko
    Head of Educational Projects, Training & Development Department, Pharmaceutical Inspectorate, SID & GP
  • Nadezhda Arkhipova
    Deputy Head of Expertise Department, SID & GP
  • Mikhail Muzykin
    Candidate of Pharmaceutical Sciences, Head of Production Laboratory, Polysan
  • Irina Tarasova
    Deputy Head, Quality System Maintenance Department, Pharmaceutical Inspectorate, SID & GP
  • Svetlana Loseva
    Lead Specialist, Pharmaceutical Standardization, Expertise and Registration Center
  • Yegor Rybakov
    Deputy General Director for Auditing, Pharmstrategia
  • Maksim Ablov
    Lead Specialist, Pharmaceutical Inspection Department, SID & GP
Contents:

  • Pharmaceutical Manufacturing. GMP guidelines
  • Quality control. GMP QC guidelines
  • Outsourcing
  • Complaints and product recall
  • Self-inspection. Conducting audits and self-inspection at pharmaceutical manufacturing facilities
  • Quality risk management (GMP Part 3, ICH Q9 guidelines). Corrective and preventive action system. Change, deviation and non-conformity management in GMP
Designed for:

  • Inspectors/auditors (current and/or aspiring)
  • Employees of pharmaceutical manufacturing facilities
  • Employees of relevant authorities and organizations
Course completion certificate:

  • Upon successful completion of the course, students are awarded a continuing professional development certificate, issued in accordance with the 273-FZ On Education in the Russian Federation law
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

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Pharmaceutical auditor training


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