Setting Realistic Timetables For Deviations, Complaints, And CAPAs
Priorities are important to have in any environment, and regulated environments are no exception. When you are planning your quality system, you must keep your priorities top of mind; otherwise, regulatory agency visits could end in trouble. When you establish timetables to address any deviation of procedure, product complaints, or even CAPAs, you have to plan realistically — or you will put yourself and your business in a very tight position. Prioritization is critical because it can be difficult to remediate too many observations at once while you are still in production. By Rosario Quintero-Vives, Senior Regulatory and Compliance Specialist, RQV Consulting
WHITE PAPERS & CASE STUDIES
Build A Culture Of Quality To Achieve Life Sciences Market Leadership
This eBook is your roadmap to building a Culture of Quality based on CAPA best practices and improvements. It presents 10 improvements that your organization can implement that will help leverage CAPA best practices to achieve market leadership.
A Challenge For Supply Chain Performance Is The Complexity
How good is your supply chain performance? Many suppliers perhaps believe theirs is pretty good; however, it seems each year when businesses are surveyed by the numerous supply chain consulting firms and trade magazines, visibility usually ranks at the top of the list as an area for improvement. Indeed, the typical supply chain has become much more complex over the years as manufacturing expands to Asia, South America, Africa, and so on.
Supply Chain ISAC Report Of Cargo Theft Activity
The Supply Chain Information Sharing and Analysis Center’s (SC-ISAC) primary mission is to facilitate communication among supply chain dependent industry stakeholders in order to help secure the global supply chain.
One Of The Biggest Challenges And Most Effective Tools To Managing Cold Chain Logistics
Making them work for you, and not the other way around, is key to your success. Quality systems at their best establish, implement, and maintain a set of processes to provide the highest quality service to customers and highest level of compliance for regulators. At their worst, they just get in the way; adding only administrative burden and redundant reviews to an already complex and fast-moving network.
Supply Chain Information Sharing And Analysis 4th Quarter 2012 Report Of Cargo Theft Activity
Understand the actions of cargo criminals and how they react to industry and law enforcement actions related to prevention and enforcement. By J.J. Coughlin, LoJack Supply Chain Integrity
Biological Contamination Events In Isolators: What Lessons Can Be Learned?
Microbiological deviation and biological contamination events have been observed in pharmaceutical isolators including those used in production, sterility test and pharmacy aseptic services. By James Drinkwater, Bioquell UK Process & Compliance Director