Now more than ever, the demand for safe and effective medical drugs is increasing on a global scale. This means that regulatory affairs teams are working overtime to interpret, apply, and communicate the guidelines received from governing bodies like the FDA and EMA when it comes to developing new drugs.
It’s a year into life post-GDRP. Amazingly, the world goes on. In fact, the General Data Protection Regulation in the European Union has gone according to plan, to the point that similar legislation is being considered in other parts of the world, including the United States.
https://blog.globalvision.co/wp-content/uploads/2020/03/compliance-gdpr-makes-its-way-to-usa.png6311201Ryan Szporerhttps://blog.globalvision.co/wp-content/uploads/2020/03/gvblog-logo1a-300x65-copy-300x65.pngRyan Szporer2019-08-28 17:05:022020-12-15 19:49:58What to Expect as GDPR Makes Its Way to the United States
With United Kingdom Prime Minister Theresa May announcing her resignation, the country’s economic future with Brexit looming over its head is as uncertain as ever. Imagine how individual companies are feeling in the aftermath of her decision and ultimate inability to negotiate a deal for Britain’s exit from the European Union.
There’s a saying: “Winning isn’t everything; It’s the only thing.” In business however, before you can win, you have to first comply with regulations.
https://blog.globalvision.co/wp-content/uploads/2020/03/compliance-fda-regulatory-compliance-affects-manufacturing.png6311200Ryan Szporerhttps://blog.globalvision.co/wp-content/uploads/2020/03/gvblog-logo1a-300x65-copy-300x65.pngRyan Szporer2019-04-15 10:51:282020-12-15 19:52:44FDA Regulatory Compliance Affects All Aspects of Manufacturing… for the Better
Of note, the Food and Drug Administration (FDA) has official data integrity guidelines, out in full force as we speak. However, firms who are already following current Good Manufacturing Practices (cGMP) have nothing to worry about.
https://blog.globalvision.co/wp-content/uploads/2020/01/compliance-following-fda-guidelines.png6311200Ryan Szporerhttps://blog.globalvision.co/wp-content/uploads/2020/03/gvblog-logo1a-300x65-copy-300x65.pngRyan Szporer2019-03-27 16:04:172021-06-21 15:58:44Following FDA Data Integrity Guidelines Is Easier than You Think
Still in its relative infancy as a discipline, regulatory affairs was created to meet a pressing need, regardless of the industry in question.
https://blog.globalvision.co/wp-content/uploads/2020/03/compliance-digital-proofing-in-regulatory-affairs.png6311201Ryan Szporerhttps://blog.globalvision.co/wp-content/uploads/2020/03/gvblog-logo1a-300x65-copy-300x65.pngRyan Szporer2019-01-18 21:14:532020-12-15 19:53:26The Undeniable Need for Digital Proofing in Regulatory Affairs
A name on a dotted line may technically hold just as much legal weight as ever, but in the era of electronic signatures a contract can be enforced without a pen ever touching paper. What Are Electronic Signatures? Indeed, electronic…
https://blog.globalvision.co/wp-content/uploads/2020/03/compliance-electronic-signature-era-has-arrived.png6311200Ryan Szporerhttps://blog.globalvision.co/wp-content/uploads/2020/03/gvblog-logo1a-300x65-copy-300x65.pngRyan Szporer2018-12-18 17:42:232020-12-15 19:53:29The Era of Electronic Signatures Has Arrived
What is the FDA? The Food and Drug Administration is a government agency that operates under the United States Department of Health and Human Services. The FDA is responsible for protecting and ensuring public health in…
https://blog.globalvision.co/wp-content/uploads/2020/01/compliance-fda-breakdown.png6311200Mike Malzhttps://blog.globalvision.co/wp-content/uploads/2020/03/gvblog-logo1a-300x65-copy-300x65.pngMike Malz2018-02-07 14:57:092020-12-15 19:56:37FDA Break-Down: What is the FDA, FDA 21 CFR and How Do You Stay Compliant?
How can you define product quality? This term can be interpreted in different ways depending on the country or region you live in, but perhaps the most crucial variable that determines what quality represents is the unique set of quality objectives…
https://blog.globalvision.co/wp-content/uploads/2020/03/compliance-iso9001-2008-certification.png6311201Marvin Magasurahttps://blog.globalvision.co/wp-content/uploads/2020/03/gvblog-logo1a-300x65-copy-300x65.pngMarvin Magasura2017-11-09 21:27:042020-12-15 19:56:41Why ISO 9001:2008 Certification is Vital for Companies
Every company needs change, but in the midst of implementing it, only a few of them think about ISO 9000. It is mostly perceived as a purely technical standard that only specific industries have to deal with. But for the experienced business…
https://blog.globalvision.co/wp-content/uploads/2020/02/760w_process-change-iso-9000-1.jpg315760Marvin Magasurahttps://blog.globalvision.co/wp-content/uploads/2020/03/gvblog-logo1a-300x65-copy-300x65.pngMarvin Magasura2017-11-09 21:14:092020-12-15 19:56:42Looking for Process Change? Think ISO 9000
No matter what industry you are in there are always new regulations which impact the way you create labelling artwork. Staying in compliance with regulatory labeling obligations is a complex undertaking that if done wrong may result in undesired…
https://blog.globalvision.co/wp-content/uploads/2020/02/760w_compliance.jpg315760Reuben Malzhttps://blog.globalvision.co/wp-content/uploads/2020/03/gvblog-logo1a-300x65-copy-300x65.pngReuben Malz2016-04-20 18:22:042020-12-15 19:58:21Having to Rework Label Artwork Again and Again to Stay in Compliance?
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