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INDUSTRY RESOURCES

27
Sep
5 Major Challenges In CRO Outsourcing — And How To Overcome Them

The second part in this series discussed the entire RFP workflow from planning though selection of the best-fit CRO and included a documentation checklist and scorecard to lend practical support to sponsors. But now that you have selected a CRO and execution challenges are bubbling up, what can you do?

Posted in:Clinical,
27
Sep
What Risk Factors Does The FDA Consider In Scheduling Drug GMP Inspections?

The FDA’s latest effort at transparency in the drug GMP inspection planning process can be found in the new Manual of Policies and Procedures (MAPP) 5014.1, “Understanding CDER’s Risk-Based Site Selection Model,” used to prioritize sites for routine surveillance GMP inspections.

Posted in:Manufacturing,
Tags:distribution,labeling,MAPP,packaging,risk,supply chain,
25
Sep
Monitoring Adverse Event Reporting On Social Media — Should You Outsource?

The ubiquitous nature of mobile devices means mining and monitoring social media channels and managing the challenges associated with them through technology, process management, and tactical outsourcing need to be considered standard operating procedure for clinical trials professionals and organizations.

Posted in:Clinical,
14
Sep
Should You Rotate Disinfectants? Industry Experts Weigh In

Whether to rotate disinfectants has been debated in the pharmaceutical industry for years. If disinfectants are not used properly, microorganisms may remain on surfaces and proliferate in the environment. This article discusses the concept of disinfectant rotation and the current mainstream industry practice regarding it.

Posted in:Manufacturing,Training,
Tags:disinfectants,microbial contamination,microorganisms,sanitizers,
11
Sep
5 GCP Compliance Mistakes To Avoid With Job Descriptions, CVs, & Org Charts

When it comes to GCP audits and inspections, low-hanging fruit says a lot about the tree.

Posted in:Clinical,Training,
10
Sep
Regulatory GMP Expectations For Learning, Training, & Performance In Pharma/Biopharma

Having a competent, professional workforce is essential to meeting the dual goals of business requirements and regulatory expectations. With a coherent plan and a well-structured learning system that is focused on performance, a pharma firm can efficiently accomplish both.

Posted in:Manufacturing,Training,
Tags:GMP.training,learning,performance,

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