DIVERSE

course topics, from R&D and clinical trials to manufacturing, global regulatory, and post-market concerns.

QUALITY

instruction from the best Subject Matter Experts in pharma, biotech, and med device.

ACTIONABLE

content that provides you with practical solutions to the toughest challenges.

INTERACTIVE

features for the adult learner including polling, break-outs, and assessments.

STAY TUNED WITH US

Subscribe for the latest pharmaceutical, biotechnology, and medical device training courses and special offers.

LIFE SCIENCE TRAINING INSTITUTE

Get to know us (by the numbers).

Life Sciences Industries Covered
Expert Instructors
Courses Run
Past participants

INDUSTRY RESOURCES

11
May
A Better Way To Document QMS Procedures & Work Instructions In Life Sciences Manufacturing

Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system (QMS) is effectively and clearly documenting procedures and work instructions that are easy to understand and execute. This article presents the requirements for documenting QMS procedures and work instructions, and then introduces methods to effectively and clearly do so.

Posted in:Manufacturing,
Tags:documentation,procedures,QMS,quality management system,standards,
09
May
The Impact Of Regulatory & Analytics Evolution On The Biopharma Industry

This two-part article explores the use of various tools and the emergence of intelligent solutions in the industry.The first part provides an overview of how technological advancements and data analytics are critical in enabling regulators and the life sciences industry.

Posted in:FDA,Manufacturing,
Tags:analytics,biopharmaceutical,intelligent solutions,
07
May
1
Someone, Everyone, Or No One: Who Owns Quality? (And Who Should)

Who is ultimately responsible for quality/the quality management system at a life science company: (A) all personnel working for the company, (B) the quality assurance department, or (C) company management (including top executives)? Note your answer somewhere before reading this article.

Posted in:FDA,Manufacturing,
Tags:QCU,quality assurance,quality control,
07
May
Considerations For Biologic Drug Substance And Drug Product Testing

Most manufacturing strategies today include some level of support from an outsourcing service provider such as a CMO or contract testing lab. There has been a great deal of discussion regarding the elevated role these providers play in the drug development process. Today’s CMO is likely to not only execute critical development activities but also provide insight based upon their own experiences with multiple processes.

Posted in:Manufacturing,
Tags:CMC,CMO,drug development,drug substance,DS,
03
May
Think Your Accessory Isn’t A Medical Device? Think Again.

The FDA guidance Medical Device Accessories – Describing Accessories and Classification Pathways, clarifies much of the confusion regarding accessory classifications, making now a good time to conduct a gap analysis to identify a thorough list of your current and future accessories, and to determine the guidance’s applicability to each.

Posted in:Device,FDA,
Tags:accessory,medical device accessories,
01
May
Strategies For Effective Risk And Capability Assessments When Choosing A Clinical Provider

Recent revisions to the International Council for Harmonisation (ICH) Guideline for Good Clinical Practice, as outlined in ICH E6 (R2), have provided an impetus for sponsors to reevaluate their oversight and quality management processes throughout the clinical development process.

Posted in:Clinical,
Tags:CRO,ICH,ICH E6 (R2),oversight,sponsors,

WHAT'S YOUR DISCIPLINE?

TESTIMONIALS