This webinar, Decoding FDA's 21 CFR Part 11 and EU Annex 11: Ensuring Compliance in Electronic Recordkeeping, provides a comprehensive understanding of regulatory requirements for electronic records and electronic signatures in the pharmaceutical, biotechnology, and medical device industries.
This webinar will provide a practical framework for identifying, analyzing, and addressing deviations in pharmaceutical and biopharmaceutical manufacturing.
This webinar, Data Integrity in GMP and GCP: Compliance with FDA, EMA, and MHRA Requirements, provides a comprehensive overview of data integrity principles, regulatory expectations, and compliance strategies in pharmaceutical and clinical environments.
This webinar, Decoding FDA's 21 CFR Part 11 and EU Annex 11: Ensuring Compliance in Electronic Recordkeeping, provides a comprehensive understanding of regulatory requirements for electronic records and electronic signatures in the pharmaceutical, biotechnology, and medical device industries.
This 60-minute webinar on Clinical Trial Risk Management will provide a comprehensive overview of the evolving regulatory landscape under ICH E6(R3) and FDA expectations for risk-based quality management (RBQM).
This 60-minute webinar explores the key differences between Agile and Traditional (Waterfall) Project Management in the life sciences industry, helping professionals determine the best approach for their specific projects
This webinar explores the power of Hybrid Project Management, combining the structured, predictable approach of traditional Waterfall methodologies with the flexibility and adaptability of Agile practices.
Effective technical writing is critical for successful regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDA), and Premarket Approval (PMA) submissions.
This 60-minute webinar provides a comprehensive guide on how to effectively prepare for regulatory inspections conducted by the FDA, EMA, and Notified Bodies.
A compliant training program is essential for ensuring personnel in GMP, GCP, and quality system-regulated environments are knowledgeable, competent, and audit-ready.
This webinar will provide a practical framework for identifying, analyzing, and addressing deviations in pharmaceutical and biopharmaceutical manufacturing.
This webinar, Data Integrity in GMP and GCP: Compliance with FDA, EMA, and MHRA Requirements, provides a comprehensive overview of data integrity principles, regulatory expectations, and compliance strategies in pharmaceutical and clinical environments.