Basic GMP requirements for manufacturers of excipients. Approval, monitoring and evaluation of suppliers

Basic GMP requirements for manufacturers of excipients. Approval, monitoring and evaluation of suppliers

Details

  • Start date: 13 March 2023
  • Start time: 10:00 (Kyiv)
  • Finish date: 15 March 2023
  • 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: 275 Euro. For each next participant — 80% discount.

     

    The objectives of the interactive course: to provide students with theoretical and practical knowledge regarding the requirements for manufacturers and suppliers of excipients. Acquaintance with the key principles of conducting an external audit. Documentation and practical examples. Examine the requirements for conducting risk analysis for excipients for compliance with GMP requirements. Obtaining practical experience in organizing the interaction of the procurement service with the departments of assurance and quality control.

     

    The course is intended for employees of the quality assurance department, purchasing personnel, production and quality control managers.

     

    Course benefits:

    • A large amount of theoretical and practical information: 5 thematic sections, 3 days of training!

    • Convenient format — 5 video lessons, 5 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. Regulatory requirements for manufacturers of excipients. Supplier selection and approval process.

    2. The procedure for monitoring and evaluating suppliers. Periodic evaluation of excipient supplier performance. Sample documents and practical examples. Practical examples.

    3. Risk-based approach to ranking on the example of manufacturers and suppliers of excipients. Documentation examples.

    4. The main aspects of the audit, assessment of the quality system; conclusion of supply contracts. Tactical techniques for conducting a supplier audit. Volume, duration, number of auditors. Peculiarities of supplier audit transfer to outsourcing.

    5. Structural interactions of the purchasing service with the departments of assurance and quality control. Completion of the dossier on the manufacturer/supplier. Regulatory notices.

    6. Practical tasks and trainings.

    7. Answers to listeners' questions.

     

    For each question:

    — Video presentation (30 minutes)

    — Presentation in pdf

    — Additional online literature

    — Questions to the teacher

    — Tasks for topics