Description
Quality Control laboratories are at the heart of every pharmaceutical and industrial quality system.
This Laboratory Systems Course provides a comprehensive, practical understanding of how QC labs operate, how data is generated and controlled, and how compliance is maintained under GMP, ISO, and Data Integrity requirements.
The course covers the full lifecycle of laboratory operations — from sample management and testing workflows to instrument qualification, method validation, documentation, and integration with electronic systems.
Participants will learn how to build and manage effective laboratory systems, ensure accurate results, avoid compliance pitfalls, and maintain a state of control.
Using real case studies from pharmaceutical and analytical labs, trainees gain strong awareness of laboratory structure, responsibilities, investigations, and interactions with regulatory bodies.
By the end of this course, participants will be able to:
- Understand the structure and functions of a GMP/ISO-compliant QC laboratory
- Apply fundamental principles of laboratory management, workflow & safety
- Implement proper sample handling, testing, and documentation practices
- Understand OOS, OOT, deviations, and laboratory investigations
- Apply Data Integrity & ALCOA+ principles in laboratory operations
- Manage instrument qualification (IQ/OQ/PQ) and calibration basics
- Align lab practices with regulatory expectations (FDA/EMA/WHO/PIC/S)
- Improve communication between QC, QA, production, and external testing labs
Who Should Attend
This course is ideal for professionals working in laboratory environments or aspiring to join QC roles, including:
- QC Analysts & Microbiologists
- QA Staff interacting with laboratory functions
- Freshly Hired entering laboratory or quality-related jobs
- Laboratory Supervisors & Team Leaders
-
R&D and Analytical Development Personnel
- Regulatory & Compliance Professionals managing lab audits
- Anyone aiming to understand how modern GMP/ISO-compliant labs operate
Key Takeaways
- Flexible Attendance Options – Join in-person at VALOR or virtually through our live interactive platform.
- Recorded Sessions – Enjoy limited access to recordings for one month after course completion for review and reinforcement.
- Repeat for Free – Participants may re-attend inperson any future round of the same course at no additional cost.
- Accredited Certificate – Receive a QR-coded certificate for authenticity verification and professional recognition.
- Comprehensive Resources – Access digital materials, trainer support, and post-course assessments through VALOR’s e-learning platform.
Course Topics
· Compendia (United States, Europe, and Japan)
· Specifications
· Microbiology and Environmental Monitoring
· Laboratory record-keeping and data Integrity requirements
· Instrument handling , control and Analytical method validation
· Sampling
· Stability programs.
· OOS & Laboratory Investigation of Atypical Results
Number Of Sessions
5 Sessions