GxP Lifeline Newsletter
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September | 2017

Supply Chain Risk Management: An Ever-Changing Mosaic
by Geary W. Sikich; Logical Management Systems Corp.


We have recognized the need to better manage supply chain risks for the nearly two decades now. Yet, we still seem to be deluded into thinking that the modern supply chain is resilient to the point of invulnerability. Developing risk management strategies and embedding resilience processes can enhance the organization’s ability to actively assess and manage risk.



Coping with Scoping a CSV/Part 11 Audit
by Laurie Meehan, Social Media Manager; Polaris Compliance Consultants


Yes, you use computers on a daily basis, and you may even use the system that needs to be audited. But you don’t spend your day thinking about where all the system components are located, how services and software are combined, and what Part 11 requirements apply.


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Canada’s Evolving Regulatory Landscape
by Raleigh Malik, PhD, Sr. Scientist; DIA


Canada’s sesquicentennial marks a period of advancement and newfound transparency, where the past has set the stage for innovators to generate novel, yet safe and effective, health care products for Canadians. From the discovery of insulin at the University of Toronto in 1921 to the development of the first HIV preventative vaccine in 2013 (which is currently undergoing Phase II trials), Canada has a rich history of drug innovation.



Add Cybersecurity Education to Every Employee’s Job Description
by David Jensen, MasterControl Staff Writer


The recent surge of security breaches and ransomware attacks is reinforcing the need to make cybersecurity an all-hands endeavor. Despite all the cybersecurity tools that companies are implementing, security breaches are still rampant because one of the top cybersecurity weaknesses in all industries is the lack of training employees on cybersecurity.


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