Participants will learn the fundamentals and importance of a robust compliance program and gain hands-on experience performing a mock compliance audit.
Participants gain knowledge in Quality Management Systems, explore aspects of the principles and responsibilities of a quality unit, understand the role quality assurance plays across functional areas and the importance of a quality culture. Participants will learn the fundamentals and importance of a robust compliance program and gain hands-on experience performing a mock compliance audit.
Objectives
- Attain knowledge about the history of quality, including regulations, guidelines, and the role of agencies.
- Learn how to build a Quality Management System with a quality culture and explore ICH Q10.
- Explore aspects of principles and responsibilities of a quality unit.
- Learn about the cost of poor quality in the product development lifecycle.
- Perform mock compliance audit to understand fundamentals and importance of a robust compliance program.
Who should attend this course?
Course work and laboratory exercises are designed for individuals working in the biomanufacturing industry including roles such as Upstream and Downstream Technicians, Quality Assurance, Quality Control, Bioprocess Engineers, Facilities, and Plant Operations.
Delivery
In-person lectures and hands on activities in a simulated GMP facility.
- Duration: 1.5 Days
- Time: Day 1: 8:00am to 4:00pm
Day 2: 8:00am – noon - Location: Kingston, RI
- Max Number of Participants: 15
Instructors
Content Outline
- History of Quality
- Regulations/Guidelines/Role of Agencies
- Principle Roles and Responsibilities of the Quality Unit
- ICH Q10 and Quality Management Systems
- Quality Culture
- The Cost of Poor Quality
- Quality and the Product Development Lifecycle
- Fundamentals of Compliance
- Auditing basics
- Mock Compliance Audit
- Review of Audit Findings