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05.04.21 -- How To Ensure Your Quality Culture Assures Data Integrity


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, ....

Comunidad Autonoma De Cataluna , Andrew Wong , Webinar Lonza , David Zimmerman , Paula Decaria , Alok Tayi , Danna Schwerdt , Andreas Meudt , Scott Martin , Derek Duncan , Jordan Ball , Michelle Nolasco Rivera , Jones Healthcare Group Packaging Services , Nikka Densok United States Inc , Case Study Flow Sciences Inc , Natoli Engineering Company Inc , Qa Stevanato Group , Solutions For Life , Evonik Corporation , Samira Shore , Thermo Fisher , Natoli Engineering Company , Brian Ball , Nikka Densok United States , Jones Healthcare Group Packaging , Mats Lundgren ,

04.01.21 -- Auditing Electronic Batch Records For cGMP Status


04.01.21 Auditing Electronic Batch Records For cGMP Status
 
Sponsor
Pharmaceutical Online and Techceuticals, in collaboration with Federal Equipment Company, are excited to announce Virtual Pharma Expo: Oral Solid Dose Manufacturing. Don’t miss this FREE LIVE event on May 5th & 6th featuring 15-minute presentations with leading OSD packaging and process equipment manufacturers. Register Now.
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 ....

Comunidad Autonoma De Cataluna , Paul Magreta , Majaz Hussain , Brian Stephens , Mukta Acharya , Jessica Settimi , Quadro Comil , Case Study Seeq Corporation , Case Study Flow Sciences Inc , Equipment Company , Article Promega Corporation , Application Note Silverson Machines Inc , Samira Shore , Thermo Fisher , John Barley , Grifols Recombinant Protein , David Winger , Federal Equipment , Maurizio Della Pietra , Particle Measuring , Brandy Sargent , Lonza Pharma , Silverson Machines , Flow Sciences , காமுனிடட தன்னாட்சி டி கடலுள் , அஜாஸ் ஹுசைன் ,

12.17.20 -- FDA FY2020 Drug Inspection Observations And Trends


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. ....

Ted Tharp , Abdelaziz Toumi , Jessica Mueller Albers , Peter Poechlauer , Martin Gonzalez , Ian Whitehall , Lonza Biologics , Charles Ross , Gibco Efficientfeed , Jeff Tremain , Christine Banaszek , Qa Lonza Pharma , Andreas Stolle , Case Study Almac Group , Case Study Flow Sciences Inc , Poster Micromeritics Instrument Corporation , Case Study Asahi Kasei Bioprocess America Inc , Case Study Dec Group , Evonik Corporation , White Paper Alconox Inc , Pharma Services , Son Company , Thermo Fisher , Pfizer Centreone Contract , Dwayne Hull , Jon Best ,