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Overview

Overview Building better FDA submissions--

Mission Statement Training Experience

Write SOPs GCP audit of CROs and Sponsors Solve Regulatory Problems Write Protocols and Study Reports Improve Submissions (Drugs, Biologics, and Devices) Audit Safety Compliance

In-House Computer Systems - Part 11 Compliance Commercial Software Products - Part 11 Compliance Improve SAS Programming

Part 11 Compliance (3 Classes) SOPs (2 Classes) Regulatory Affairs (7 Classes) Statistical Analysis (2 Classes) SAS Programming (3 Classes) Adverse Event Reporting (2 Classes) Entering Data into ClinicalTrials.gov (4 Classes)

	SOPs
	Two of Training Classes
	Class Title	Description
1	Writing SOPs Part 1: An Introduction	A discussion about the how and why of writing SOPs including FDA expectations and regulations.
2	Writing SOPs Part 2: Advanced Problems, Advanced Solutions	A discussion about advanced topics regarding the development, implementation and compliance of SOPs used by FDA regulated companies.