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23
Apr
Measuring COVID-19’s Impact On Availability Of Drugs And API From India And China

COVID-19 has caused an increase in demand for APIs and drugs; those used as antimalarials are seeing the highest demand, followed by bronchodilators, antibiotics, and antivirals. This article reviews the drugs and API in demand globally, with assessments of their supply status in India and China.

Posted in: Manufacturing,
Tags: API, COVID-19, critical drugs, drug shortage,
21
Apr
How To Accelerate Adoption Of Patient Technology In Clinical Trials

Although the benefits of implementing it in clinical studies are evident, patient technology has yet to make a clear entrance into the clinical arena, as many trials continue to rely on traditional research methodology.

Posted in: Clinical,
Tags: CRO, digital technology, patient technology, PT, PT adoption,
20
Apr
What To Expect From The FDA During (And After) COVID-19

During a recent Halloran Virtual Town Hall meeting, a panel of experts to share what they are seeing in terms of regulatory activity, as some cases are receiving expedited feedback, while others are experiencing delays in reviews and receipt of commentary from the FDA. This article presents some key insights from the panel’s experience conducting regulatory activities during the pandemic.

Posted in: Clinical, FDA, Manufacturing,
Tags: CBER, CDER, CDHR, COVID-19, FDA,
20
Apr
Applying Aseptic Practices To Protect Yourself From COVID-19

During this COVID-19 pandemic, we have all heard it: Wash your hands with soap and water for at least 20 seconds. This article focuses on transferring basic aseptic techniques and good hygiene practices learned in the pharmaceutical industry to help you dodge the COVID-19 bullet.

Posted in: Manufacturing,
Tags: aseptic, cleanroom, COVID-19, hygiene,
17
Apr
An Introduction To Quality Agreements For Pharmaceutical Outsourcing

Any time a contractor or CMO is used, including arrangements between different divisions of the same company, regardless of the location of the parties involved, there should be a quality agreement in place.

Posted in: Manufacturing,
Tags: CGMP, CMO, ICH guidance, quality agreements,
15
Apr
Identifying Difficult-To-Clean Or -Inspect Surfaces In Manufacturing And Packaging Equipment

This article describes a practical risk-based approach for assessing and identifying the surfaces, areas, or sites of manufacturing and packaging equipment that are cleaned upon completion of oral solid dosage manufacturing production.

Posted in: Manufacturing,
Tags: direct product contact, DPC, indirect product contact, IPC, NPC, on-product contact, packaging equipment,