Internal skill building and addressing talent shortages are critical challenges for startups in the therapeutic goods sector. The scarcity of highly specialised quality, regulatory, and compliance professionals creates operational and strategic pressures, particularly for early-stage companies navigating complex ISO, GMP, and GxP frameworks.
The TGA’s "Educate to Empower" initiative, as outlined in the 2026–2027 Compliance Principles, provides a robust framework for supporting therapeutic goods organisations in regulatory compliance.
Reducing data integrity risks requires a comprehensive approach that integrates robust training, clear procedures, and organizational commitment. Training ensures that personnel understand the principles of data integrity, apply Good Documentation Practices, and recognize their individual responsibilities in maintaining accurate, complete, and reliable records.
For pharmaceutical, biotechnology, and medical device organizations, investing in data integrity and documentation training ensures that operational processes are reliable, staff are competent, and regulatory obligations are consistently met.