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07 09 21 -- 5 Foundations Of Lean Leadership For Pharmaceutical & Medical Device Professionals
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06 25 21 -- Statistical Methods To Compare Small-Scale Models To At-Scale Biopharmaceutical Manufacturing
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05.04.21 How To Ensure Your Quality Culture Assures Data Integrity
Several biopharma startup veterans share their insight and inspiration on navigating clinical-stage regulatory considerations in this ebook.
Find advice and wisdom from biopharma leaders on:
Chemistry, manufacturing, and controls (CMC) considerations for first-in-human studies,
Gap analysis fundamentals,
And the relationship between GMP and CMC.
Join Biotech Makers to network, share expertise, and get perspectives on common challenges. Collaborate and connect with your peers. Join Now.
Featured Editorial
By Chris Smalley, ValSource
One solution to ensuring data integrity is to automateBr processes, essentially removing the human element. But not all instances of data generation and capture can or should be automated. With humans our team members engaged in data generation and capture, the quality culture is a major pathway
04.01.21 Auditing Electronic Batch Records For cGMP Status
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Featured Editorial
By Tim Sandle, Ph.D., Bio Products Laboratory Ltd.
This article presents some advice for auditing electronic batch records to assess their cGMP status. This is useful in the qualification stage and essential once the electronic record system is in operation.
Industry Insights Article
12.17.20 FDA FY2020 Drug Inspection Observations And Trends
ISR’s Health Panel includes managers, directors, executives, and subject matter experts in clinical development and drug manufacturing who work at pharma companies, service provider companies, and research sites. Members are paid for their time (a 15-minute survey may pay $40, whereas a 45-minute phone interview may pay $150) and they get to choose which research opportunities to participate in. Apply here.
Featured Editorial
This article presents the FDA s most recent publication of GMP drug inspection data, which address drug inspections conducted in FY2020. We examine data from FY2020 and evaluate five years worth of trends in drug GMP inspection enforcement.
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