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Parenteral Drug Association Connecting People, Science and Regulation ®

PDA India Chapter Advancing Science in Drug, Device & Primary Packaging Workshop

Aug 28 - Aug 29, 2018 |
Aug 29, 2018 |
Welcom Hotel Vadodara | Vadodara, India
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RC Dutt Rd, Alkapuri, Vadodara, Gujarat 390007, India

Container closure performance and integrity are critical for providing robust protection to sensitive drug formulations against a large variety of physicochemical stresses.

The system must work together to ensure accurate dosing and delivery to the patient.

These attributes must be maintained throughout the product lifecycle, ranging from the manufacturing, storage, and distribution, to use and disposal by end users.

With half a day factory visit and one and a half days the classroom
session to address the complexities and challenges to container closure performance and integrity.

Learning Objectives

  •  Process for assuring packaging quality across the product lifecycle
  • Explain defects in glass vials (a) Molded (b) Tubular
  • elamination issues in glass - Possible causes and techniques for mitigation
  • Regulatory consideration for packaging lifecycle
  • Case study on opportunities in design and quality evaluation of drug delivery and device packaging
  • Causes of particulate matter attributed to packaging material and eliminating particulate matter
  • Case study on Prefilled Syringe (PFS): Optimization of a unit operation for a drug delivery system for complex injectables
  • Challenges with selection of closures during development, scale up and full scale manufacturing

Who Should Attend

  • Research & Development Team
  • Packaging Team
  • Technology Transfer Team
  • Quality Assurance Team
  • Quality Control Team
  • Packaging
  • Manufacturing Team
  • Regulatory Affairs

    Registration

    Delegate Basic Rate

    GST at 18%
    As levied by Govt of India

    Total (INR)
    Non- Member 22,000 3,960 25,960
    Member 20,000 3,600 23,600

    Please download the registration form for payment information.

    Contact Information

    For further details, please contact Biny Joseph at pdaindiachapter@gmail.com or call +91 98860 76191

  • Register Now
    https://www.pda.org/docs/default-source/website-document-library/chapters/events/india/advancing-science-in-drug/registration-form.pdf

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