GMP for Medical Devices
Jan Warner is an accomplished, broad-based regulatory, quality and compliance professional with over 25 years of experience in the following products and industries: medical devices, pharmaceuticals, OTC and personal care, homeopathic drugs, dietary supplements, and medical devices. He has held numerous upper management responsibilities in quality assurance, compliance and quality control at companies such as Pall Corporation, L’Oréal, Luitpold Pharmaceuticals, Axiom Pharmaceuticals, Johnson and Johnson and Nobel Biocare. He is the owner of IQA Consulting Services; a niche provider of quality and compliance services to the FDA and similarly regulated industries. Jan has extensive experience working for Fortune 500 as well as start-up companies.
Jan received his B.S. in Biology from SUNY Stony Brook and his MS and MBA in Management of Technology from New Jersey Institute of Technology.
A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, including a component part, or accessory: recognized in the National Formulary (NF), or the United States Medical Pharmacopoeia (USP) that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.
The QS regulation applies to finished device manufacturers who intend to commercially distribute medical devices. A finished device is defined in 21 CFR 820.3(l) as any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.
Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s). CGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Medical Devices Act.
- Premises Equipment
- Raw materials and packaging materials
- Finished Product
- Quality control laboratory
- Treatment of product that is out of specification
Course Level - Basic / Fundamental
Who Should Attend
Those in the following disciplines and titles will gain insight into this training:
- Directors of - Quality Control, Quality Assurance, Production, Operations, Distributor's od medical devices products, Subcontractors and suppliers of raw materials to the medical devices industry, Subcontractors and suppliers of services to the medical devices industry, Contract laboratory services.
Why Should Attend
The quality system regulations include requirements related to the methods used in and the facilities and controls used for designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices. FDA inspects manufacturing facilities to ensure compliance with the QSR requirements.
Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMPs).
Because the QS regulations must apply to many different types of devices, the regulation embraces an “umbrella” approach rather than prescribing in detail how a manufacturer must produce a specific device. The regulations provide the framework that all manufacturers must follow by requiring manufacturers to develop and follow procedures and fill in the details that are appropriate to a given device according to the current state-of-the-art manufacturing for that specific device.
Manufacturers should use good judgment when developing their quality system and apply those sections of the QS regulation that are applicable to their specific products and operations. Operating within this flexibility, each manufacturer has the responsibility to establish requirements for each type or family of devices that will result in devices that are safe and effective and to establish methods and procedures to design, produce, distribute, etc. devices that meet the quality system requirements. The responsibility for meeting these requirements and for having objective evidence of meeting these requirements may not be delegated, even though the actual work may be delegated.