Regulatory agencies the world over have put in place stringent requirements for ensuring that cleaning validation procedures for analytical equipment are effective. Even if putting these practices in place involves expense and effort, it is worth the trouble, because the cost of noncompliance is much, much higher than that of compliance.Noncompliance with regulations for cleaning validation procedures for analytical equipment has a serious consequence: Regulatory bodies such as the FDA could…See More
The Role of Safety Advisor in Organisations – Essential ReadingWhilst everyone wants to do ‘safety differently’, it is not likely that reform will come within. The paradigm of safety with its primary focus on measurement actually mitigates any hope of innovation, creativity or critical thinking. If safety is now the…See More
Establishing Quality Systems is one of the central aspects of a medical device and/or pharmaceutical organization. Establishment of Quality Systems is also a regulatory requirement, as set out by the FDA and the ISO.The process of establishment of Quality Systems for FDA-regulated medical devices industries is set out in 21 CFR Part 820. Further, the ISO has its standard for how to establish Quality Systems in medical devices industries –the ISO 13485 standard –which has to be implemented as…See More
Business Communication systems are the processes, both informal and formal, by which information is passed between the employers and employees within a business, or between the business itself and…Continue
Started by Chris John. Last reply by Jay D. Rohman Jun 29, 2016.
A member of my association (the American Society of Safety Engineers) asks for information on the following:I have heard cloud computing may have greater risk for third party subpoenas and government…Continue
Started by Cory Zielke. Last reply by Chris John May 27, 2016.
The business of managing risk is changing. Take advantage of this opportunity to examine best practices, discuss trends, learn new technologies, and much more, as ASSE (the American Society of Safety…Continue