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

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• 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, Director, Project Management, Prometheus Theraputics & Diagnostics

  Sam Yazdani provides consulting in Biotech start ups, project management and Quality Systems. He has experience in GLP & GMP, held Sr. Project Management positions at various biotech companies, and was President and Director of Quality at Global LIMS Software, SoilCore and Synergic Analytics. He has three life science US patents and an MBA from USC.

• 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.