Technological process. GMP requirements. Dossier of the production site. Documentation

Technological process. GMP requirements. Dossier of the production site. Documentation

Details

  • Start date: 13 December 2022
  • Start time: 10:00 (Kyiv)
  • Finish date: 15 December 2022
  • Finish time: 18:00 (Kyiv)
  • Duration: 3 days, 24 academic hours
  • Break: yes
  • Category: Production (GMP)
  • Format: Streaming
  • Online broadcast available: yes
  • Venue: Online
  • Language class: Русский
  • Cost of education:

    225 Euro (pre-sale until 06.12.2022) + 45 Euro for each next participant;

    250 Euro (from 06.12.2022) + 50 Euro for each next participant

     

    The objectives of the interactive course: familiarization of students with theoretical and practical knowledge regarding the requirements for the technological process at enterprises for the production of medicinal products for humans and veterinary use. Acquisition of skills in the formation of the Dossier of the production site, in the development and approval of the Technological Regulations, the Production Recipe, the Protocols for the production and packaging of the series. Consideration of examples of registration of changes and deviations during the technological process. Acquisition of practical experience in the selection of manufacturers / suppliers of raw materials and materials. Mastering the key principles of the work of a process engineer. Fundamentals of process validation.

     

    The course is intended for quality assurance staff, purchasing staff, production and quality control managers.

     

    Course benefits:

    • A large amount of theoretical and practical information: 4 thematic sections, 3 days of training!

    • Convenient format — 4 video lessons, 4 presentations and practical exercises.

    • Individual pace of learning — you can study the material and perform practical tasks on your own schedule, without reference to the group, time and place of the lesson.

    • No passive participation — effective personal feedback from the teacher during the entire training period. Opportunity to consult with the teacher during the course and after the end of the course.

    • Availability — you can study from any device at a convenient time.

    • The course "in your pocket" — the ability to view / review the lesson at any time, download training materials and submit work for verification by the teacher.

    • Interactive learning takes place on the basis of the Google Classroom platform.

    • A member's registered gmail address is required to participate.

    • It is possible to connect to an interactive practical class before the end of the course.

     

    Course structure:

    1*. Technological process according to GMP requirements. Requirements of normative documents. General requirements for production documentation and quality system documentation. Development and approval of the Dossier of the production site. The procedure for making changes to the Dossier of the production site.

    2*. Technological regulations: structure, procedure for registration, approval, amendments. Production recipe, technological instruction, series production and packaging protocols. Practical examples of design, sample documents.

    3*. Management of changes and deviations. Documentation and implementation of changes. Investigation of deviations and preparation of CAPA Plans. Raw materials and materials - requirements. Choice of supplier/manufacturer. Information about the technological process in the Registration dossier.

    4*. The position of process engineer – duties and responsibilities, roles and functions.

    Production planning. The main aspects of the validation of the technological process.

    5. Practical tasks and trainings.

    6. Answers to listeners' questions.

     

    * Each question in the format: Video presentation (30 minutes) + Presentation in pdf + Additional online literature + Questions for the teacher + Assignments to the topic