If you drive a commercial motor vehicle (CMV) in the United States, you may face roadside inspections at any time. These inspections are conducted under the authority of the Federal Motor Carrier Safety Administration (FMCSA) to check compliance with
LAW: Dietary Supplement Manufacturing and Quality Compliance GMP Record Retention Laws for Dietary Supplement CompaniesWhat 21 CFR Part 111 Requires You to Keep and for How Long Record retention under 21 CFR Part 111 is not a filing preferenc
If you drive a company vehicle for work, how you drive matters, not just to your safety, but also legally. Your actions on the road can affect your employer and your own record. This guide breaks down what the law says about defensive driving for emp
Workplace safety is a legal and moral responsibility. In the United States, the Occupational Safety and Health Administration (OSHA) sets clear rules on what employers must report when something goes wrong. If a worker is seriously hurt or dies,
Confined spaces are common on construction sites, manholes, tanks, silos, crawl spaces, and vaults, to name a few. But not every confined space is the same. Some of these spaces are more dangerous than others and require a legal process before anyone
LAW: FDA cGMP Compliance How FDA Inspects Computerized Systems Under cGMP: A Legal Overview Computerized systems in pharmaceutical and biotech manufacturing are subject to FDA inspection under 21 CFR Parts 211 and 820, the agency's data integ
LAW: Medical Device Quality and Regulatory Compliance FDA Complaint Handling for Medical Device ManufacturersWhat the QMSR and ISO 13485 Clause 8.2.2 Require Complaint handling is one of the most inspected areas in FDA medical device audits.
LAW: Code of Conduct Compliance What Makes a Code of Conduct Legally Enforceable? Key Elements and Pitfalls A Code of Conduct is not just a values statement. In the right circumstances, it functions as a contractual document, a disciplinary f
In pharmaceutical and biotech manufacturing, changes to processes, equipment, or materials must be handled carefully. That’s why change control is a critical part of any company’s current Good Manufacturing Practice (cGMP) system. But when change con
