Level
Intermediate
Prerequisites
Participants should possess basic knowledge of Good Manufacturing Practices (GMP), working in a regulated environment, and quality systems. Please contact us if you are uncertain whether you meet these prerequisites.
Format
On-site, practical, including essential theory
Duration
1 day
Cost
$1,045
Overview
This course equips participants to perform equipment qualification effectively in regulated (GxP) environments. Covering the full qualification lifecycle—along with the execution and documentation of protocols for biological safety cabinets (BSCs)—it provides the skills needed to maintain compliance, prevent costly errors, and protect product quality and patient safety.
Participants gain practical, hands-on knowledge in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), the core elements of equipment compliance across the pharmaceutical, biotech, and cosmetics sectors.
Why It’s Essential
Failing to properly qualify equipment can quickly lead to regulatory findings, operational delays, and reputational harm. Whether onboarding new personnel or upskilling experienced teams, this course provides the technical and regulatory foundation every regulated manufacturing organization needs and helps:
- Avoid health authority sanctions: Meet FDA, Health Canada, and global GMP standards
- Prevent costly errors and rework: Minimize deviations caused by improperly qualified equipment
- Strengthen quality culture: Understand and apply rigorous qualification processes from day one
- Protect the bottom line: A single qualification misstep can trigger product recalls, shutdowns, or worse. This course is a high-value, preventive investment.
Learning Objectives
Participants will gain the capability and confidence to:
- Distinguish between validation and qualification processes and understand why both matter
- Navigate the full equipment qualification lifecycle with clarity
- Understand the roles and requirements of IQ, OQ, and PQ protocols
- Develop structured, audit-ready qualification protocols
- Execute and document qualification activities in alignment with best practices
- Analyze qualification data to prove equipment fitness for purpose
Who Should Attend
This course is designed for employees of organizations seeking to standardize and elevate their approach to equipment qualification. It is ideal for:
- Validation engineers and technicians
- QA professionals
- Maintenance and calibration personnel
- Production managers and supervisors
- New hires operating in GMP-compliant roles
Participants who successfully complete a theoretical assessment will receive a certificate of completion.
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