For more than 15 years, SeerPharma has proudly collaborated with the Malaysian Organisation of Pharmaceutical Industries (MOPI) to design and deliver regular Good Manufacturing Practice (GMP) training programs for pharmaceutical and medical device manufacturers across Malaysia. These training sessions are endorsed by, and frequently attended by, representatives from the Malaysian regulatory authority – the National Pharmaceutical Regulatory Agency (NPRA).
In 2024, over 350 Quality and GMP professionals from Malaysia’s pharmaceutical and medtech sectors participated in our training courses. The 2025 training calendar features five virtual courses delivered via Zoom and nine in-person sessions in Kuala Lumpur.
The objective of this program is to provide participants with a solid conceptual foundation in GMP, while introducing current industry practices for practical implementation in the workplace. The curriculum encompasses core principles of Quality Assurance (QA) and GMP, and explores specialised topics such as Validation, Supply Chain Management, and Auditing. These sessions also address the current expectations of PIC/S and emerging international trends in the regulated life sciences sector.
Our training approach integrates case study workshops, interactive group activities, and real-world scenarios to enhance learning and application.
Qualification and Validation Training – Kuala Lumpur, 27th-28th May 2025
In May, SeerPharma Singapore Consultant Smitha Kenchath delivered the fourth training session of the year in Kuala Lumpur, focusing on Qualification and Validation in the pharmaceutical and medical device industries.
This comprehensive two-day course covered the following key areas:
Foundational Concepts in Qualification and Validation (Q&V)
- Regulatory expectations and the scope of Q&V
- Phases and stages of the Q&V lifecycle
- Essentials of validation planning and compliance strategies
Validation Planning Essentials
- Structure and components of a validation program, including the Validation Master Plan (VMP) and
- Validation Project Plan (VPP)
- Integration of Quality Risk Management (QRM) principles using science- and risk-based methodologies
- Differentiation between critical and non-critical systems
- Practical tools such as Failure Mode and Effects Analysis (FMEA) and Hazard Analysis and Critical Control Points (HACCP)
Execution, Assessment, and Documentation
- Best practices in equipment qualification, including User Requirement Specifications (URS) and qualification stages (IQ, OQ, PQ) aligned with GMP standards
- Risk-based approaches to qualification
- Protocol execution, evaluation, and deficiency management
- Strategies for maintaining a validated state through robust change control
- Lifecycle validation concepts, including routine re-validation and periodic performance reviews
Click here for more information and the full 2025 training schedule with MOPI
