Program Description

The QC Lab Testing Fundamentals Certificate Program develops foundational competency for professionals who support quality control (QC) laboratory operations in GMP environments. Blending ISPE’s GMP essentials with practical QC laboratory skills and ICH recommendations, the program strengthens the knowledge needed to generate reliable data, make sound release decisions, and sustain inspection-ready performance across the product lifecycle. 

Program Structure

Learners complete three coordinated courses (self-paced On Demand), then earn the ISPE Academy Certificate in QC Lab Testing Fundamentals.

1) GMP Fundamentals – Eleven-Part Bundle (On Demand)

A cohesive GMP primer designed for new and experienced professionals, this eleven-course bundle surveys core GMP regulations and good practices across manufacturing and quality operations. The series covers topics such as manufacturing controls, product distribution, plant hygiene, documentation, buildings & facilities, and organizational structure, and is positioned both as an introductory pathway and an annual refresher for personnel who must understand and apply GMPs in daily work. 

2) Analytical Quality Control Fundamentals (On Demand)

This course provides a foundational overview of essential QC laboratory practices—explaining not only what happens in the lab, but why these practices protect product quality, regulatory compliance, and patient safety. Using practical examples and structured guidance, learners explore sample handling and scheduling, sampling techniques by material type, instrument operation and qualification, calibration, control samples, system suitability, and data integrity/GxP documentation. The course also highlights how accurate, timely QC data supports prompt, risk-based product release decisions and aligns with ICH Q6A recommendations. (Course modules: Introduction, Sample Management, Sampling Techniques, QC Instrumentation, Qualification & Calibration, Control Samples & System Suitability, Data Accuracy & Integrity Fundamentals, Regulatory Framework & ICH Q6A.)

Outcome: Build fluency in the principles and workflows of analytical QC labs and apply best practices that reinforce data integrity, consistency, and trust in product quality within GMP manufacturing.

3) ICH Q6A – Specifications, Test Procedures & Acceptance Criteria (On Demand/Webinar)

Focused on ICH Q6A, this course explains how to define specifications, test procedures, and acceptance criteria for new drug substances and products, and how these expectations support global regulatory consistency and patient safety. The content situates Q6A within the broader ICH landscape—linking to ICH Q8/Q9/Q10/Q11 to encourage science- and risk-based approaches. It is self-paced (typical completion 1–3 hours) and provides CEUs upon achieving the required passing score and evaluation. 

Outcome: Understand the connection between ICH Q6A recommendations, practical QC specifications and testing strategies that align with risk-based product and process understanding.

Course Curriculum

Why This Program?

• ISPE-Aligned Curriculum. Content draws on ISPE training and guidance so learners can apply practices consistent with industry expectations and the ISPE Academy competency model.
• Grounded in Good Practice Guides (GPGs). The QC laboratory course references ISPE Good Practice Guides and relevant QC resources (e.g., Quality Lab Facilities GPG) to promote practical, “how-to” application in lab design/operations and documentation practices. 
• Lifecycle & Compliance Focus. Emphasis on data integrity, traceability, and continuous inspection readiness across sampling, testing, and release. 

What You’ll Learn

By completing all three courses, participants will be able to:

• Explain the role of QC laboratories within a GMP-compliant Pharmaceutical Quality System, and how lab data informs quality decisions and product release. 
• Apply fundamental QC lab practices for sample management, instrumentation/qualification, calibration, control samples, system suitability, and data integrity. 
• Outline ICH Q6A recommendations and integrate science- and risk-based thinking (Q8/Q9/Q10/Q11) into specifications and acceptance criteria. 
• Connect GMP expectations to day-to-day QC activities, documentation, and inspection readiness. 
• Reference ISPE Good Practice Guides to support consistent, efficient laboratory operations and facility considerations. 

Who Should Enroll

• QC analysts/technicians, QA specialists, and documentation/data integrity staff
• Manufacturing and release/CMO oversight personnel who interact with QC labs
• Early-career professionals seeking a structured, ISPE-aligned QC foundation

Pricing

Now Your Whole Team Can Participate in an ISPE Learning Experience

• 3 - 5 participants - Save 10%
• 6 - or more participants - Save 20%

Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.

Cancellations/Refunds

Cancellations must be made in writing. If cancellations are received by 60 days prior to event start date, a full refund, minus a $150 handling fee, will be issued. After that time, no refunds will be granted. Please be advised that if your payment or written cancellation notice is not received prior to the cancellation date, your credit card will be charged the prevailing rate. Refund requests must be in writing and emailed or faxed to +1 (813)-264-2816. (Telephone messages are not accepted). ISPE reserves the right to modify the material or presenters for this event without notice, or cancel an event. If an event must be canceled, registrants will be notified by ISPE. ISPE will not be responsible for airfare penalties or other costs incurred due to cancellation.

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For an enhanced learning experience, ISPE also offers these learning activities as live courses and gives you an opportunity to learn with a live instructor, ask questions, and participate in exercises. View Upcoming Courses