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FREE shipping on qualifying offers. According to the FDA Quality System Regulations, manufacturers must ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing.

According to the FDA Quality System Regulations, manufacturers must ensure that "device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution. As specific as this statement is, the FDA does not provide instructions for how to achieve their standards. This handy reference demystifies the validation procedure for medical device packaging by providing specific examples and templates for creating and maintaining a validation file.

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Find many great new & used options and get the best deals for Validating Medical Packaging by Ronald Pilchik . Highlighting the development in industry regulations, this book demystifies the validation procedure

Highlighting the development in industry regulations, this book demystifies the validation procedure. It presents real-life examples and case studies, templates for creating and maintaining a validation file.

Validating Medical Packaging demystifies the validation procedure for medical device packaging by providing specific examples . Ronald Pilchik has over 30 years of experience in the healthcare manufacturing industry.

Validating Medical Packaging demystifies the validation procedure for medical device packaging by providing specific examples and templates for creating and maintaining a validation file. About the author: Ronald Pilchik has over 30 years of experience in the healthcare manufacturing industry. As principal of the Techmark Group, he provided consulting services to diverse multinational manufacturers on selecting, developing, and validating medical packaging compatible with their sterilization requirements.

Ivica Klapan, Ronald Poropatich - Remote Cardiology Consultations Using Advanced Medical Technology: Applications for NATO Operations (NATO Science Series: Life and . Ronald Pilchik - Validating Medical Packaging.

Ivica Klapan, Ronald Poropatich - Remote Cardiology Consultations Using Advanced Medical Technology: Applications for NATO Operations (NATO Science Series: Life and Behavioural Sciences,. Series I: Life and Behavioural Sciences). Ivica Klapan, Ronald Poropatich. What is Validation? Package Design Validation. Elements of Package Design. Package Design Issues. Depending on the chemical properties, temperature withstanding capacity and packaging, appropriate methods of sterilisation needs to be selected. In addition, the process has to be validated for its sterilisability and residuals Medical Device R&D-a Goldmine for Open Innovation.

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