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Taiwan-Berkeley Health Innovation Accelerator : Health & Biomedical Resources

Identify VC investors, life science market analysis, FDA regulations

Articles

US FDA

The FDA sets policy and formulates rules and regulations governing how new drugs, medical devices, and more are developed, approved, and brought to market. The scope of the US Food and Drug Administration's regulatory authority is very broad, and includes:

NIH Research; Clinical Trials

Online Books

Additional books may be found by searching UC Library Search.

Limit to online books if desired by checking the box on the left side of the search results page.

SOPs for Regulatory Applications for the Pharmaceutical Industry

Collection of 11 videos (with PDFs of slides) from The Biomedical & Life Sciences Collection, Henry Stewart Talks on topics such as:

  • Effective SOP Writing
  • Procedural assessments of SOPs to ensure SOPs are logical and meet GXP requirements
  • SOP Training
  • Using process mapping, forms and templates for the production of SOPs

Regulatory Agencies require written procedures for all systems and operations which impact the quality and safety of pharmaceutical products. Standard Operating Procedures (SOPs) provide the main forum for the documentation of a pharmaceutical company's systems and operations and compliance with GXP such as GCP, GPV, GMP and GLP.

Public Health Librarian; Interim Optometry & Vision Science Liaison

Profile Photo
Michael Sholinbeck
(he/him)

Schedule a consultation,
or visit during my office hours
@ BPH DREAM Office (Room 2220, Berkeley Way West Bldg),
Tuesdays 4-530pm; Thursdays 130-3pm;
(Contact me for Zoom alternative).

Find Research Protocols

IGOs, NGOs, Associations, etc.