SeerPharma Blog

SeerPharma to Deliver GMP and GLP Workshop at Duke-NUS CORE

Written by SeerPharma | Feb 20, 2025 1:19:58 AM

A decade ago, Duke-NUS Medical School in Singapore, established the Centre of Regulatory Excellence (CoRE) to enhance health products regulatory systems and competency across ASEAN and the broader Asia-Pacific region. CoRE is pivotal in supporting policy innovation and facilitating progress towards effective and efficient health product regulation. As a neutral academic platform, CoRE bridges the gap between industry and regulators, fostering the development of future regional regulatory leaders for the healthcare ecosystem.

SeerPharma is proud to collaborate with CoRE in delivering a training workshop on “Good Manufacturing and Laboratory Practices for Pharmaceutical, Biotech, and Medical Devices: Operational Excellence from R&D to GMP Compliance”.

This in-depth 4-day training and workshop is designed for professionals in the pharmaceutical, biotech, and medical device sectors who are seeking to enhance their understanding and operational knowledge of GMP (Good Manufacturing Practices) and GLP (Good Laboratory Practices). The course will emphasize the operational aspects of GMP compliance, focusing on the key operational challenges that arise as companies transition from R&D to GMP-compliant environments. With practical case studies, interactive workshops, and real-world problem-solving, this course will enable professionals to manage day-to-day operations effectively while ensuring quality, regulatory compliance, and operational excellence.

The workshop will be conducted over two sessions at Duke-NUS Medical School’s campus in Singapore:

  • 27 - 28 March 2025 (Session 1)
  • 3 - 4 April 2025 (Session 2)

Learning Objectives

  • Gain a deep understanding of GMP and GLP, focusing on their operational application in the pharmaceutical, biotech, and medical device industries.
  • Apply operational strategies for transitioning from R&D to GMP-compliant manufacturing, including scaling, documentation, and quality systems integration.
  • Implement and manage operational controls to ensure the integrity of product quality across manufacturing and lab environments.
  • Manage complex GMP challenges including process validation, deviations, CAPA (Corrective and Preventive Actions), and non-conformances in a real-world operational context.
  • Lead cross-functional teams in risk-based decision making and regulatory compliance for GMP/GLP.
  • Prepare for and manage inspections and audits, ensuring compliance with regulatory bodies (FDA, EMA, etc.).
  • Drive continuous improvement in GMP and GLP operations through advanced techniques and best practices.

We are honoured to support and contribute to the ongoing mission and efforts of Duke-NUS CoRE.

Click here for more information and to register to attend this person 4-day workshop.

Partnering with leading academic institutions such as Duke-NUS CoRE, reaffirms our commitment to “Advancing Quality and GMP Best Practices in the APAC region”.