In Latvia alone there have been at least three GDP License revocations over the last year, with several licenses under review, similar situation is in Lithuania and Estonia.

LEARNING OBJECTIVES

  • Understad the pharmaceutical supply chain system GDP compliance requirements
  • Manage critical documentation to cover the whole supply chain
  • Learn how to evaluate and assess the risks
  • Mitigate risks of pharmaceutical products in the global supply chain
  • Comply with cool chain management guidelines
  • Be ready for serialisation compliance required by 2019sales

TOPICS TO BE COVERED

  • Introduction to Pharmaceutical Logistics & GDP
  • Interactive Exercise: Terminology and abbreviations
  • Interactive Exercise: Identification of CCPs during the supply chain
  • Global GDP Regulations
  • Why Packaging matters?
  • Freight solution evaluation
  • EU GDP Guidelines for medicinal products for human use
  • Introduction to Serialisation
  • Legislative Environment
  • Target Response(s) Products and serialisation
  • Process supply chain impact, IT impacts

ARE YOU COMPLIANT?

Advanced Good Distribution Practices and Serialisation Course presented by the world’s most respected experts in GDP auditing, strategy, compliance & preparation for serialisation. This intensive, packed with practical and interactive exercises two-day course is designed for professionals with at least two years experience in drug supply chain management. The course was developed following extensive research and consultation with the industry professionals in the Baltic area and will provide a comprehensive, yet practical assessment of regulations required for compliance during inspections.

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CANCELLATIONS: Confirm your cancellations in writing 3 weeks before the date and receive a 50% refund. Should you cancel between this date and 1 week before the date of the course regrettably you will not receive a refund. Customer may reschedule a booking to another date at a 100% rescheduling fee by advising Rephine Balticum of such rescheduling in writing. It may be necessary for reasons beyond the control and the organiser to alter the content and timing of the program or the identity of the trainers. In the unfortunate event that an event is cancelled Rephine Balticum are not liable for any costs incurred by delegates in connection with their attendance. This contract is subject to Latvian Law.