The 2022 revision of the PIC/S Guide to GMP for Medicinal Products (PE 009-17) Annex 1 is expected to be adopted by the Therapeutic Goods Administration (TGA) in 2025 and Contamination Control Strategy (CCS) has emerged as a key new requirement. While CCS under Annex 1 is central for sterile drug manufacturers, it is also applicable for...
Artificial Intelligence is reshaping industries at a rapid pace—and life sciences is no exception. While excitement about AI’s potential is high, many quality and manufacturing teams remain in the early stages of implementation. In this webinar, discover how MasterControl is closing this gap with innovative, purpose-built AI solutions that elevate...
Audit trails play a crucial role in ensuring data integrity, traceability and compliance with Good Manufacturing Practice (GMP) regulations. Under the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-16), Annex 11 outlines specific requirements for computerised systems, emphasising the need for audit trail reviews....
As a quality manager for a life sciences company, you face unique challenges in maintaining high quality standards while planning for growth - often with limited resources and budget constraints. Choosing the right quality management system (QMS) is critical, but how do you balance compliance, efficiency, scalability and value without making...
As life sciences organizations face increasing complexity in quality management, artificial intelligence (AI) presents a transformative opportunity. According to McKinsey, AI can add $100 billion in value to life sciences,1 with quality and manufacturing processes representing a significant portion of this opportunity. With successful...
Charles River is a global leader in providing products and services that support pharmaceutical and biotechnology companies, government agencies, and academic institutions in accelerating research and drug development. With a presence in over 150 facilities across 21 countries, Charles River has a longstanding history of contributing to the...
With over 35 years of experience, SeerPharma has been at the forefront of supporting cutting-edge medical device and medtech companies in Quality and GxP compliance. Over the years, we have witnessed the rapid rise of implantables, neurotech, and diagnostic technologies—areas that continue to shape the future of healthcare.
SeerPharma is pleased to announce a strategic partnership with QACV Consulting, enhancing our ability to support clients in the United States.
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...
SeerPharma is proud to sponsor and participate in the 2nd Annual Eye & Tissue Banking Conference, hosted by the Eye Bank Association of Australia and New Zealand (EBAANZ).
Copyright © SeerPharma
