Course offering number:0911-702
Course ID:
2337
The China Syndrome: Quality Issues in Manufacturing
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This online training course is intended for professionals in the pharmaceutical industry. It will be especially valuable to:
• CMOs, Contract Manufacturing Organizations
• CMC specialists
• Pharmaceutical manufacturing organizations
• Regulatory affairs professionals
Description
This 90-minute accredited online training explores the root causes of quality concerns with China API and pharmaceutical product. Discussions
will include the FDA's current and planned response to this issue. Decision formulae for determining whether or not to use China-based
suppliers will also be addressed.
Module 1: FDA Concerns about China
quality control
• Past problems with contaminants
• Independence of inspectors
• Corruption issues
Module 2: Root causes of China quality
problems
• Factory design
• Capitalism run amuck: short term gain vs.
long term relationships
• Government over-control
Module 3: To use of not to use: how to
answer the question
• Increased independent surveillance
• Corruption controls
• Re-test and QbD control
Question and answer session