Pharma/Clinical/Dietary Supplements/Medical Devices
A Message from Heather Howell
This edition looks at the issues impacting the pharmaceutical, device, and dietary supplement sectors in 2022.
Reflecting on my six years with NSF and my FDA career, there has never been a more exciting time in Health Sciences. As we emerge from this pandemic, our industry is at a crossroads of patient demand and patient safety, and much has changed since the last edition of this journal.
The criticality of scientific research, clinical studies, and post-market surveillance has been at the forefront of the news with the development of lifesaving Covid-19 products. Global supply chain concerns have weighed heavily on manufacturers' minds as essential materials have been hard to source, and costs have hit an all-time high. This issue was keenly discussed in our recent Symposium, and you can read more about it in this edition. Nonetheless, the life-sciences sector continues to protect global health and introduce new medicinal products and devices into the market.
Our pharmaceutical and medical device teams have been busy supporting clients around the globe as we begin to feel the impact of the U.S. FDA resuming onsite inspections. The steps manufacturers can take to help ensure inspection readiness as regulators around the world resume these activities is a recurring theme in this issue.
I hope you find the articles in issue 49 helpful, and I encourage you to share them with your industry colleagues. Our fiftieth issue, published later this year, will take an in-depth look at the NSF Health Sciences Symposium and, again, focus on the issues that continue to reshape our industry.
7 Factors That Support Successful Human Error Investigation
At a Glance
Two of the Most Common IVDR Challenges (With Solutions)
White Paper: Tools and Tips for Writing Effective Nonconformity Statements During Quality Management System Audits of Medical Device Manufacturers
By Robert (Rob) Ruff
Beyond a Requirement: The Value of Highlighting Postmarketing Safety Efforts
Amazon Trends & Insights: What's Fueling the Sports Nutrition Boom?
A Journey to Knowledge With NSF
In the News
Is the IVD Industry Truly Ready for the IVDR DoA?
April 25, 2022
Pharma Pipeline at All-Time High
May 6, 2022
NSF Collaborates With Wegmans To Launch "Verified With Confidence" Program
April 12, 2022
Spotlight on Training
NSF’s training courses are highly interactive and based on real scenarios, helping you meet international requirements throughout the product lifecycle. Check out our featured medical devices, pharma and dietary supplement courses, or view our full course offering.
Dietary Supplements - Quality and Compliance Training Event
NSF’s digital training event is back for 2022! The courses provide an excellent platform for all dietary supplement companies to understand basic quality management systems and current Good Manufacturing Practice requirements. Depending on your role, you can choose to participate in courses ad hoc or purchase the Master Pass.
Writing Effective Nonconformity Statements During a Medical Device QMS Audit
Human Performance: Beyond Human Error
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