Packaging Validation & Shipping Qualification

Instructor: Richard Gaeto
Product ID: 701006
  • Duration: 60 Min

recorded version

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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Sep-2008

Training CD / USB Drive

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Read Frequently Asked Questions

This presentation will discuss the differences between qualifications and validations as they apply to shipping and packaging.


The objective of a shipping qualification program is to verify that product can be shipped throughout the supply chain within required temperature ranges and without damage. To accomplish this companies must conduct operational and performance qualifications for their shipping configurations. The operational qualifications consisted of temperature mapping of test loads that are challenged with “worst case” temperature profiles under controlled laboratory conditions. The performance qualifications were performed concurrent with actual product shipments.

With increased focus on validations and qualifications during regulatory inspections it is imperative for companies to develop programs that reduce their risks and provide assurances of regulatory compliance and approval. The objective of packaging validations is to provide documented evidence that vial labeling and secondary packaging processes operate and perform as specified and meet cGMP requirements. Validation Master Plans must be adhered to and follow a detailed protocol that addresses equipment installation qualification, product operation qualification and performance qualification.

Areas Covered in the seminar:

  • Defining validation & Qualification.
  • Processes involved in Shipping Qualifications.
  • Processes involved in Packaging Validations.
  • Importance of Validation Master Plan.

Who will benefit:

This presentation will discuss the differences between qualifications and validations as they apply to shipping and packaging.

  • Supply Chain & Logistics Personnel
  • Validation & QA Managers
  • Distribution personnel
  • Packaging & Labeling personnel
  • Logistics & Tranportation Personnel

Instructor Profile:

Richard Gaeto, Newcastle Strategic Partners provides integrated supply chain solutions to the Life Science Industry. Newcastle Strategic Partners has extensive Bio-Pharmaceutical and Medical Device experience in all aspects of the Supply Chain including strategy development and implementation, process improvement, systems integration, distribution, 3rd party logistics and more. Richard Gaeto, President of Newcastle Strategic Partners has worked with several of the leading biotechnology companies throughout his career leading Supply Chain Strategies for such companies as Centocor, Immunex, Amgen, Dendreon and ZymoGenetics. The work done for these companies included Formal Cost Reduction Programs, Cold Chain Management, Strategic Sourcing Initiatives, Product Launch Strategies, Brand Protection Programs, Distribution Programs, Packaging Initiatives, Channel Management and Global Transportation Strategies.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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