Process Validation and Sustaining

Packaging Fundamentals provides an overview of essential concepts related to packaging in the context of medical devices. It covers the applicable standards and regulatory requirements, an exploration of packaging materials and key topics.

Duration: 16 hours

Modality: Group

Participant limit: 15

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“Measurement System Analysis (MSA) Fundamentals” provides a comprehensive understanding of measurement variation and its impact on quality assurance within the medical devices industry.

Duration: 12 hours

Modality: Group

Participant limit: 15

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Learn about the change control process, the interaction with different elements of the quality system, and the considerations when creating a process change assessment.

Duration: 9 hours

Modality: Group

Participant limit: 15

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This course offers a complete immersion in the Design of Experiments (DOE) methodology for process characterization.

Duration: 24 hours

Modality: Group

Participant limit: 15

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The primary goal of this course is to provide the student with the tools and learning of the DMAIC methodology as a process improvement approach. Students will also learn about various tools that help assess and enhance the quality of processes.

Duration: 9 hours

Modality: Group

Participant limit: 15

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Learn the entire process validation cycle and the key elements such as VMP, EQ, OQ and PQ, and the correlation with the regulations and standards

Duration: 24 hours

Modality: Group

Participant limit: 15

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Learn about the 8D Methodology for Root Cause Analysis / Structured Problem Solving.

Duration: 8 hours

Modality: Group

Participant limit: 15

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Learn about the correct methods validation that can help the organization to minimize risk which could be associated to over-rejection or worst shipping product that is defective to customer.

Duration: 12 hours

Modality: Group

Participant limit: 15

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