Friday, 11 May 2018Tom Colgan, Director of Cyber Security, Pilgrim Quality Solutions, an IQVIA company
As agents of quality and compliance within the Life Sciences industry, we are all well aware of the importance of security awareness training in order to be compliant with various frameworks, laws, and regulations, including HIPAA
. But in practice, does your organization’s awareness program simply “check the box,” or do you believe your efforts are having an impact?
Friday, 04 May 2018Caroline Freeman, Principal Consultant, Consulting Services, IQVIA
Phil Johnson, Senior Director, Quality & Compliance Services, IQVIA
Despite having a longer transition of five years compared to the three years for the EU Medical Devices Regulation (EU MDR), the In Vitro Diagnostics Regulation (IVDR) provides IVD manufacturers with a much higher hurdle to jump over than the EU MDR1
for “general” IVD manufacturers. Due to this higher hurdle, IVD manufacturers must not sit back and wait for the commotion of the MDR to die down before implementing their transition.
Adding to the pressure of the May 2022 IVDR transition deadline, other, even shorter deadlines should force IVD manufacturers into action sooner. These include Health Canada’s mandate for adherence to the Medical Devices Single Audit Program (MDSAP), and the end of transition of EN ISO 13485:2016.
Tuesday, 01 May 2018Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
Knowing your suppliers is as important as knowing the material they provide. Life Sciences regulators around the globe could not agree more! If you have a product defect, it doesn’t matter who is at “fault”, your supplier or your own organization.
Ultimately regulators are going to hold your organization (the license holder for the finished product) responsible for the quality
of the materials and services your suppliers provide you. This is evidenced in recently updated standards and regulations such as ISO 13485:2016 and EU MDR, or long-standing standards such as 21 CFR Part 820 and Part 211, or ICH Q9 and Q10. However, and more importantly, the only thing the public will see and react to is your product and your brand. It pays to maintain tight oversight of your suppliers
, and not just for compliance
Friday, 27 April 2018Kevin Lee, Industry Solutions Manager, Pilgrim Quality Solutions, an IQVIA company
On a day-to-day basis, most of us are busy taking care of the details. We’re fixing problems as they happen, checking things off to-do lists, and responding to emails. But as we move through our busy days, most of us are aware of the periodic need to take a step back, look at the big picture, and assess our progress against our goals. That high-level look often reveals trends that need to be reinforced or changed as we move forward. Nowhere is this truer than within a quality system. The seemingly small or micro details that we work through each day add up with other processes and details to form the bigger (macro) picture of our organization’s risk.
Tuesday, 24 April 2018Bill Buzzeo, General Manager, U.S. Center of Compliance Excellence, IQVIA
The quality, regulatory, safety, and commercial compliance management areas are quite often looked at as organizational necessities rather than value-added functions. They also are areas that sometimes lack innovation and transformation.
In a recent global survey of pharmaceutical CEOs, regulatory concerns continue to be viewed as a threat to growth. In fact, since 2013, these concerns, collectively, are among the top three threats as reported by pharma executives (PWC’s 20th Annual Global Pharma CEO Survey)