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Packaging and Labelling

Dates

Times

3 days12 hrs VILT, 2 hrs self-paced

Location

Virtual Learning

Availability

About This Course

This course relates to the packaging and labelling of drug products.

This highly interactive course, is part of NSF’s training program for the Certificate in Pharmaceutical Quality, linked to the US FDA’s 6 systems approach.

Our virtual instructor-led training will be delivered via a combination of live instructor-led virtual classrooms and self-paced online learning. Full details will be sent following registration.

Key Learning Objectives

On completion of this course, delegates will know and understand:

  • Background on different packaging materials and their selection, uses, control and impact on product stability.
  • Packaging design considerations to protect both the product and the patient including labelling, anti-counterfeiting, tamper evidence and serialization.
  • Packaging operations and their risks and control.
  • Typical packaging issues impacting the Quality Unit’s decision making.

Course Outline

Packaging Components

  • Primary (contact) materials, their composition and properties
  • Choosing the most appropriate material for specific applications
  • Artwork management
  • Requirements for receipt, sampling and testing

Packaging Process

  • Packaging operations (the cGMP challenges)
  • Packaging machinery (selection and qualification)
  • Automatic security and detection systems
  • Start-up checks and in-process controls
  • Line clearance and cleaning
  • Batch packaging record design and reconciliation

Who Should Attend

Quality Unit Professionals and Pharmaceutical Technical Professionals

  • These courses are suitable for professionals working at drug product manufacturing and packaging sites and those whose role requires them to understand packaging processes, such as auditors, staff with quality oversight responsibilities and regulators.
  • Many industry professionals from a range of disciplines attend the courses as part of their continuing professional development.

Course Tutors

Course tutors will be selected from the following:

  • Dave Waddington
  • Shannon Wills
  • Matt Kruschlich

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