Medical Devices 2021 - Production and Process Controls for Medical Devices What You Need to Know

Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce products. Because Production and Process Controls are so critical they are one of the major subsystems emphasized in inspections by the FDA.
Failure to adequately implement Production and Process Controls (P&PC) can lead to disaster for your company… or even worse… for your customer. And P&PC continues to be a leading cause of 483 and warning letter observations from the FDA.
Establishing P&PC
Change Control
Environmental Control
Speaker:
Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance