Compliance and Validation Training Courses
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Understanding Pharmaceutical Packaging
This course provides attendees with an overall appreciation of the complex activities/technology involved in the life-cycle of Pharmaceutical Packaging projects, ranging from material/pack selection/design (based on the product dosage form and product material characteristics), through to the final validation of the Packaging Process and subsequent Ongoing Process Verification. Within this range the course covers: applicable regulatory guidance/rules and international standards; emerging legislation on counterfeit, falsified medicines and product security; development goals for new packaging design and the packaging options available; testing and evaluation of packaging/materials involving; stability and functional testing, extraction and migration studies; and leachables. The course also covers key properties of primary packaging materials/forms and will cover the barrier properties offered in terms of temperature resistance, chemical compatibility and physical properties. Example of primary packaging materials will include glass, plastics, and metals and packaging formats including laminates, blisters, tubes and closures.
A general introduction to the qualification and validation of packaging equipment will be given and this will lead into more detailed presentations covering: risk assessments to determine depth and scope of testing; the qualification of pharmaceutical packaging equipment; testing at the key stages of qualification, including packing safety features design and qualification (e.g. Serialization, Anti-tamper and 2D Data Matrix Codes); Packaging Process Validation (scope, approaches and sampling/testing - multiple examples) and Ongoing Process Verification.
Attendees will be provided with a 3-slide per page printed binder upon arrival on Day 1 and PDF versions of the slides will be sent out by email to each delegate after the course.
Day-time meals and refreshments are included in the overall package. There will be an informal social gathering of attendees and presenters on the evening of Day 1 (Tuesday 13 May 2025, 18:30 onwards), which will include drinks and a sit-down dinner (fully complementary and everyone is welcome).
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Tuesday, 13th May 2025 to Thursday, 15th May 2025 (3 days)
Radisson Blu Royal Hotel, Dublin, Dublin 8, Ireland
09:00 - 17:00
£2,500 per delegate
NOTE: Course fees will be subject to a 20% UK VAT charge if your billing/invoice address is in the UK and/or delegates are UK based
