FDASmart Inc., FDA Inspection Training Courses, FDA Consultant, FDA Compliance, FDA Audit, FDA Consulting

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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)

	Regulatory Affairs
	Seven of FDASmart ’s Training Classes
	Class Title	Description
1	What Needs To Be In A Product Submission: An FDA Reviewer’s Perspective	A discussion of how FDA reviewers think and work and how to use that information to improve the structure and content to a submission.
2	FDA’s New Guidance and Enforcement: Company Web Sites, Email & Online Advertising	An overview of recent FDA actions affecting Internet communication about products and product risk.
3	Foreign Clinical Studies: New FDA Regulations	A review of the new 21 CFR 312.120 regulations, published in the Federal Register on April 28, 2008, about good clinical practice requirements for non-IND foreign clinical trials.
4	Implementing FDA’s 2008 Guidance on the Integrated Summary of Effectiveness (ISE)	A discussion of FDA’s new recommendations on the ISE section of an NDA or BLA submission.
5	Annual Reports: SOPs for Developing Content That Meets FDA Requirements	A discussion about annual report SOPs for drugs, biologics and devices that will produce content that meets FDA regulatory requirements. INCLUDES FIVE MODEL SOPs
6	Survey of FDA Reviewer Training: Understanding Reviewer Strategies, Tools, & Techniques	A discussion about how FDA reviewers are trained and how to use that information to build better submissions.
7	Good Review Management: FDA’s Internal Standards and Expectations of Industry	A discussion standards and processes meant to improve FDA performance and the quality of submissions produced by regulated industry.