Packaging Validation & Shipping Qualification
Instructor:
Richard Gaeto
Product ID: 701006
- Duration: 60 Min
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
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.
Refund Policy
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