Industry Material

Title 21 CFR Part 11

Title 21 is the portion of the Code of Federal Regulations (CFR) that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). Part 11 applies to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries, with some specific exceptions. It requires that they implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing the electronic data that FDA predicate rules require them to maintain. A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11.

Good Clinical Practice

All National Institutes of Health (NIH)-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials are required to be trained in Good Clinical Practice (GCP).

The principles of Good Clinical Practice (GCP) help assure the safety, integrity, and quality of clinical trials by addressing elements related to the design, conduct, and reporting of clinical trials. GCP training describes the responsibilities of investigators, sponsors, monitors, and IRBs in the conduct of clinical trials.

GCP training aims to ensure that:

• the rights, safety, and well-being of human subjects are protected

• clinical trials are conducted in accordance with approved plans with rigor and integrity

• data derived from clinical trials are reliable

Books

Basically every book from IT Revolution Press

	Brave New Work: Are You Ready to Reinvent Your Organization? When fast-scaling startups and global organizations get stuck, they call Aaron Dignan. In this book, he reveals his proven approach for eliminating red tape, dissolving bureaucracy, and doing the best work of your life.
	The Phoenix Project: A Novel About IT, DevOps, and Helping Your Business Win As close to an “essential” book about IT as there is. Short, easy to read, and impactful.
	The Fearless Organization: Creating Psychological Safety in the Workplace for Learning, Innovation, and Growth Absolute must-read for anyone with a job.
	The Lean Startup: How Today’s Entrepreneurs Use Continuous Innovation to Create Radically Successful Businesses The legendary book about Lean Startup practices
	A Seat at the Table Excellent reading for those interested in IT and technology leadership
	The Toyota Way: 14 Management Principles from the World’s Greatest Manufacturer The book that you don’t think is relevant, interesting or enjoyable but it’s all three. This contains the genesis of many Agile processes such as Kanban, JIT-everything and more.