Mr.Alan M Golden

This webinar will present strategies and tools for doing a complete and comprehensive impact assessment of supplier change notices. Tools and procedures for deciding if full impact assessments need to be processed and when notices for lower impact changes can ...

This webinar will discuss setting up statistically justified sampling plans for process validation. The discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validati ...

This Webinar will outline the basics of design control for medical devices and the device part of a combination product. Failure to develop these products under design control may result in a product that is not suited for the intended market or failure of app ...

In this webinar, we will discuss how to successfully prepare for and host a regulatory audit at you site. We will delve into how to prepare for the arrival of the auditors, what kind of people with what skills are needed for the audit team and how to conduct t ...

Overview of design control for medical devices with and emphasis on verification and validation of design inputs. Webinar will cover basic regulations regarding verification/validation of inputs, trace of inputs to verification/validation and techniques includ ...

This Webinar will outline the basics of design control for medical devices and the device part of a combination product. Failure to develop these products under design control may result in a product that is not suited for the intended market or failure of app ...

Overview of Design Control for Medical Devices, with an emphasis on design inputs. Seminar will go over regulations, basic concepts in design control and importance of design inputs and how to write appropriate inputs.

Attend this webinar to learn the importance of doing a complete impact assessment prior to implementation of changes under change control. Tools and techniques will be presented to aid in organizing and streamlining impact assessments.

This webinar will discuss setting up statistically justified sampling plans for process validation. Discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation w ...