Maetrics Offers Free FDA Regulatory Guides to Pharma & Medical Device
Maetrics is pleased to offer New Desktop Compliance Reference Guides that relate to both the Pharmaceutical and Medical Device industries. These guides were developed by Maetrics professionals to provide quality and regulatory personnel in these respective industries with an intuitively designed tool to access the most important compliance guidelines pertaining to them.
Focusing on the key aspects of FDA regulatory guidelines, these new guides are delivered in a durable, spiral bound format and are a totally free tool available to quality and regulatory professional upon request.
Items included in Medical Device Regulatory Guide of CFR Title 21: Food & Drugs are:
- Part 7: Enforcement Policy
- Part 11: Electronic Records; Electronic Signatures
- Part 803: Medical Devices; Reports of Corrections and Removals
- Part 820: Preamble
- Part 820: Quality System Regulation
Items found in the Pharmaceutical Regulatory Guide of CFR Title 21: Food & Drug include:
- Part 7: Enforcement Policy
- Part 11: Electronic Records; Electronic Signatures
- Part 58: Good Laboratory Practice for Non-Clinical Laboratory Studies
- Part 210: Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs; General
- Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
- Part 314: Applications for FDA Approval to Market a New Drug
- Draft Guidance for Industry: Process Validation: General Principles & Practices
Maetrics is dedicated to providing clarity and lean compliance solutions to manufacturers in the Medical Device, Pharmaceutical and Biotech industries. We provide expert analysis and solutions to compliance and quality issues, and by deploying our team on an issue, we help our clients develop quality and compliance systems that run residually leaner, thus providing directly to a manufacturers bottom line. We hope our regulatory desk reference guides serve as another great resource provided by Maetrics to simplify the functions of compliance and quality. Contact us today to get your free copy.
