Advanced QA/QC for Drugs & Biologics

Highlighting the challenges facing QA/QC in today's pharmaceutical manufacturing and control environment, this course examines what it takes to have an effective, functional QA/QC. Instruction covers the risk management decisions that the Quality Unit must make for (1) failure and Out of Specification investigations, (2) approving validation protocols and reports, (3) setting scientifically defensible specifications, (4) establishing quality agreements when outsourcing, and (5) preparing for regulatory inspections. The role of QA/QC in auditing GXPs (GMP, GLP, and GCP) will be covered.

Note: Prerequisite: "Introduction to QA/QC for Drugs and Biologics" required.

Course Number: BIOL-40021
Credit: 3.00 unit(s)

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4/4/2022 - 6/6/2022

$675

Online

Closed

• SECTION ID:

  163712

• CLASS TYPE:

  Online Asynchronous.
  
  This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
  You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.

• INSTRUCTOR:

  Yazdani, Saeid, VP of Portfolio Management, Caribou Biosciences

  Saeid Yazdani brings more than 30 years of experience in Drug and Device QA/QC, Program and Portfolio Management, and leadership experience in organizations such as Caribou Biosciences, Huyabio Therapeutics, Thermo Fisher, Nestle Health Science, Merck KGaA, Genentech (Roche), Gilead Sciences, University of Michigan, and Upjohn Phamecuiticals as well as operating his own Analytical Lab (CRO) for ten years (Synergic Analytics). Saeid currently serves at Caribou Biosciences as VP of Portfolio Management supporting a portfolio of off-the-shelf immune cell therapies for the treatment of cancer. He brings years of global experience as an impactful cross-functional global Portfolio and Program Manager & delivering on strategic drug development & business initiatives and targets. He l...Read More

• TEXTBOOKS:

  No information available at this time.

• POLICIES:

  No refunds after: 4/11/2022.
  

• NOTE:

• DATE & LOCATION:

  4/4/2022 - 6/6/2022
  extensioncanvas.ucsd.edu
  You will have access to your course materials on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.