In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA ...
In a pre-Budget statement, the Confederation of Indian Industry (CII) on Sunday said that the government should reduce red tape, simplify regulatory frameworks, and reduce compliance burden for ...
considering regulatory compliance, business concerns, and intellectual property rights. Compliance can be greatly improved by concentrating on the basic elements of CAPA investigations, advises Kate ...
Implement controls to manage residual risks within acceptable levels. Examples: Risk assessment frameworks and continual monitoring. 5. Compliance with Legal and Regulatory Requirements Ensure ...