Activity
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We are excited to share key aspects of our Follow-up Processing in Intake Automation with UltraIntake, that differentiate our solution and align with…
We are excited to share key aspects of our Follow-up Processing in Intake Automation with UltraIntake, that differentiate our solution and align with…
Liked by Kelly Jordan
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Great event this morning to see ProPharma named in the Top 100 businesses in North Yorkshire! Thanks to The Press and York St John University
Great event this morning to see ProPharma named in the Top 100 businesses in North Yorkshire! Thanks to The Press and York St John University
Liked by Kelly Jordan
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Compliance Is Not Quality. Compliance is a by-product of quality, at best. It will give you the right to obtain a manufacturing license, or a…
Compliance Is Not Quality. Compliance is a by-product of quality, at best. It will give you the right to obtain a manufacturing license, or a…
Liked by Kelly Jordan
Licenses & Certifications
Publications
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Summary Considerations: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers
ProPharma Group
Here I provide some key summaries and considerations relative to FDA’s draft guidance that was submitted for review and comment in June 2017.
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Top Takeaways from FDA’s Guidance on Data Integrity
ProPharma Group
On the Blog: What you need to know about the latest FDA guidance on Data Integrity.
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Best Practices In Life Sciences For Avoiding Data Integrity & Quality Pitfalls
Pharmaceutical Online
Understand the regulatory perspective and identify current best practice thinking relative to what one can do from a compliance and quality perspective to avoid and detect data integrity issues and overall data quality pitfalls.
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Best Practices in Life Sciences for Avoiding Data Integrity and Quality Pitfalls
Bioprocess Online
Understand the regulatory perspective and identify current best practice thinking relative to what one can do from a compliance and quality perspective to avoid and detect data integrity issues and overall data quality pitfalls.
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Lean CSV Requirements and Planning – How to Reduce Waste, Increase Value, and Maintain Compliance
ProPharma Group
Building onto a previous post, Lean CSV - How to Reduce Waste and Increase Value, today's blog focuses on specific lean considerations within the first phase of the Computer System Validation (CSV) lifecycle.
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Lean CSV – How to Reduce Waste and Increase Value
ProPharma Group
A computer system validation (CSV) program, like any other subject matter area within a quality management system has business processes it follows that inherently have waste built into them.
More activity by Kelly
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Thank you, Clinical Leader! #WeAreProPharma
Thank you, Clinical Leader! #WeAreProPharma
Liked by Kelly Jordan
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Anyone familiar with the Cressey Fraud Triangle (Google it if you don't know) understands that pressure is a key driver to deception and data…
Anyone familiar with the Cressey Fraud Triangle (Google it if you don't know) understands that pressure is a key driver to deception and data…
Liked by Kelly Jordan
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📢 Excited to share the opening call for abstracts to DIA's Regulatory Submissions, Information and Document Management (#RSIDM) Conference! February…
📢 Excited to share the opening call for abstracts to DIA's Regulatory Submissions, Information and Document Management (#RSIDM) Conference! February…
Liked by Kelly Jordan
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We're thrilled to see Kirk Wroblewski, ProPharma's new #CIO, featured in CIO Online's article. Kirk is an excellent addition to our team, with over…
We're thrilled to see Kirk Wroblewski, ProPharma's new #CIO, featured in CIO Online's article. Kirk is an excellent addition to our team, with over…
Liked by Kelly Jordan
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