We are offering a 1-day training course covering the essential “what you need to know” when it comes to GMP Part I Manufacturing Medicinal Products. Learn about the key requirements in each of the 9 chapters including the main inspection focus areas and how to avoid an audit finding.
This comprehensive course provides a practical and structured understanding of ISO 14971:2019, the international standard for the application of risk management to medical devices. Designed for professionals working in medical device design, manufacturing, and quality assurance, the course guides participants through the principles, requirements, and implementation of an effective risk management process throughout the product...
PharmOut has been training on Computer Systems Validation since 2008, much has changed recently, surprisingly Data Integrity remains a hot topic with regulators. This course examines the latest GAMP 5 second edition, including the new chapters on cloud storage, Artificial Intelligence, Machine Learning, and Blockchain) as well as recent developments, i.e. FDA’s draft Computer Software...
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Phone: +61 3 9887 6412
Email: info@pharmout.net
