Understanding TIR 45 can be the roadmap for improving development and benefiting everyone, companies, development teams, caregivers, patients, and regulators.
Why should you Attend:
Perhaps you're a development manager, hoping to improve both productivity and quality. Or you are a quality assurance manager, facing a demand from management and development to permit a move to Agile.
Areas Covered in the Session:
- TIR 45 comes at a much needed time
- TIR 45 stitches together the important high-level concepts
- Implementation issues are not ignored
- This TIR is actually just a starting point
Who Will Benefit:
- Software Developers
- Business Analysts
- Requirements Analysts
- Product Managers
- Portfolio Managers
Brian Shoemaker consults for healthcare products companies on computer system validation, software quality assurance, and electronic records and signatures. He has conducted validation both on product software and on internal software, developed software quality systems, audited software quality processes, and evaluated 21 CFR Part 11 compliance.
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