There were two tracks at the event focusing on design control, and the other on process verification and validation. With this compendium, you don't have to miss a single session and you get all the benefits of receiving the content from our stellar faculty.Subject Matter Experts Include:Roberta Goode, MSBE, CQE President, Goode Compliance InternationalTim Carr Process Validation, Non-Product Software and Inspection Manager, Beckman-CoulterAsmita Khanolkar Manager, Manufacturing Engineering, CequrGeorge Omae Senior Engineering Manager, MedtronicAnd many others!Download

Examine key consideration in the global regulatory landscapeTackle the complexities of supplier partnerships in validation Overcome challenges in TMV for diagnosticsBuild a strategic plan for facility validation Delve into risk management in change controlUtilize risk to optimize V&V sampling plansLearn more about risk management in change control Presenters included: CAPT Kimberly Lewandowski-Walker, Senior Regulatory Officer, Office of Compliance, Division of International Compliance Operations, Medical Device Single Audit Program, CDRH, U.S. FDAAdam E. Saltman, M.D.,...

Allan Marinelli's Test Method Validation Protocol outlines the program pertaining to each method in order to determine repeatability, reproducibility, accuracy, and reliability.

Titles and Authorship:PrefaceRoberta GoodeAt-A-Glance Steps for Bringing Medical Devices from Concept to CommercializationWilliam KnabRobust Design Methodology Using Attribute Data in Product/Process DesignMatt HedrickDesign for Manufacturability and Assembly (DFMA)Asmita KhanolkarProtecting Your Innovations: Patent ProtectionDavid MetzgerVerification and Validation for Use in the Medical Device IndustryDenise DionThe Application of Risk Management to Process Validation, Supplier Controls, and CAPAEdwin BillsConducting Test Method ValidationGeorge OmaeBest Practices for Documenting Objective Evidence...