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Overview

Overview Building better FDA submissions--

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)

As part of our audioconference preparation, We identify documents that supplement our presentation material. We refer audioconference participants to this web site for additional material. This FDA-related information should be useful to everyone.

For each new audioconference, We'll be adding more documents to this tab, so check back often for new information.

List of 22 Audioconferences Developed and Presented by Joshua Sharlin

(Includes SOP Titles)

Table 1 of 3. Summary of Dr. Sharlin’s Training Classes
	Topic	Number of Audioconferences (1)
1	Part 11 Compliance	1 (1 - 2)
2	SOPs	2 (3 – 4)
3	Regulatory Affairs	6 (5 – 10)
4	Statistical Analysis	2 (11 – 12)
5	SAS Programming	4 (13 – 16)
6	Adverse Event Reporting	2 (17 - 18)
7	Requirements for Entering Data Into ClinicalTrials.gov	3 (19 – 22)
	Total	22
(1) Numbers in parentheses are row numbers in the next table

Table 2 of 3. Twenty-two Training Classes Developed and Presented by Dr. Sharlin
	Title		Description	SOPs
(1) Part 11 Compliance
1		How To Audit Information Systems for FDA Compliance	A discussion about conducting an audit or preparing to be audited for compliance with 21 CFR Part 11 regulations (electronic records and electronic signatures.)	No SOPs
2		Summary and Key Points from the Final Version of the Guidance, “Computerized Systems Used In Clinical Trials”	A summary of new information in the final (May 2007) version of the guidance, “Computerized Systems Used in Clinical Trials” and how to improve compliance based on this new information.	No SOPs
(2) SOPs
3		How To Write SOPs, Part 1	An overview of the how and why of writing SOPs. Includes FDA expectations and regulations. Emphasis is on the “SOP on SOPs”.	(1) SOP on SOPs
4		How To Write SOPs, Part 2.	Advanced topics regarding the development, implementation and compliance of SOPs used by FDA regulated companies. Includes global SOPs, flowcharting and SOP deliverables.	No SOPs
(3) Regulatory Affairs
5		New Regulations for Conducting Clinical Trials Outside the U.S.	How the April 2008 version of 21 CFR 312.120 regulations (Foreign clinical studies not conducted under an IND) permits more flexibility in executing a non-IND foreign clinical trials.
6		Summary of the August 2008 Guidance on the Integrated Summary of Effectiveness (ISE)	A discussion of FDA’s new recommendations on the ISE section of a NDA or BLA submission	No SOPs
7		What You Must Know About Annual Report Compliance	A discussion about annual report SOPs for drugs, biologics and devices that will produce content that meets FDA regulatory requirements.	(1) Biologics Annual Reporting
				(2) Device Annual Reports Required of Sponsors and Investigators Before Product Approval
				(3) Device Annual Reports Required of A PMA Sponsor, Manufacturer or User Facility
				(4) IND Annual Report
				(5) Drug Post Approval Annual Reports
8		Learn What Reviewers Learn: An Overview of FDA Reviewer Training:	A review about how FDA reviewers are trained and how to use that information to build better submissions. Includes an overview of over 1,000 documents.	No SOPs
9		Good Review Management Principles	A discussion of standards and processes meant to improve; a) FDA performance, and b) the quality of submissions produced by regulated industry.	No SOPs
10		Understanding How FDA Reviewers Think and Work	This audioconference explains how reviewers think and work and how to use that information to improve submission content and organization. It is intended to remove the mystery about how reviewers do their job and make reviewers' actions and reactions predictable.	No SOPs
(4) Statistical Analysis
11		Understanding Adaptive Design	An overview of the basics for implementing adaptive design and Bayesian statistical analysis. Intended for non-statisticians.	No SOPs
12		How to Get Maximum Benefit Working With Your Statistician	How to use statistics to improve the design, execution and analysis of clinical trials. Intended for non-statisticians.	No SOPs

(5) SAS Programming
13		How To Increase SAS Programming Quality and Efficiency, Part 1 of 2	A discussion about understanding how SAS works, including the program data vector, SAS supervisor and compile time and execution time statements.	No SOPs
14		How To Increase SAS Programming Quality and Efficiency, Part 2 of 2	An advanced discussion about understanding how SAS works. Explanation of the rules for how missing values are set and how observation pointers are moved.	No SOPs
15		How To Write SAS Code and Be 21 CFR Part 11 Compliant	A review of the required processes and needed SOPs needed by a SAS programming group to be in compliance with FDA's electronic record and electronic signature regulations as described in 21 CFR Part 11. Includes 15 SOPs.	(1) Initial SAS Installation (4 pgs)
				(2) SAS Validation Overview (4 pgs)
				(3) SAS Requirements Specifications (6 pgs)
				(4) SAS High Level Study Design
				(5) SAS Program Design (6 pgs)
				(6) SAS Database Specification (4 pgs)
				(7) SAS Directory Structure (4 pgs)
				(8) SAS Coding Conventions (10 pgs)
				(9) SAS Log Review (8 pgs)
				(10) SAS Change Control (10 pgs)
				(11) Debugging SAS Logic Errors (8 pgs)
				(12) SAS Testing (7 pgs)
				(13) Maintain SAS Installation (4 pgs)
				(14) Create SAS Transport Files (3 pgs)
				(15) SAS Program Risk Assessment (10 pgs)
16		A Survey of SAS Testing Methods	What's reasonable, practical and possible for testing SAS code in a FDA regulated environment and the role of testing in Part 11 compliance. Includes 5 SOPs.	(1) SAS Program Risk Assessment (10 pgs)
				(2) SAS Log Review (8 pgs)
				(3) SAS Testing (7 pgs)
				(4) Debugging SAS Logic Errors (8 pgs)
				(5) SAS Change Control (10 pgs)
(6) Adverse Event Reporting
17		A Survey of Adverse Event Reporting Requirements for Drugs and Biologics	A summary of FDA’s regulations about AE reporting for drugs and biologics. Advice on how to improve reporting processes. Includes 9 SOPs.	(1) IND Safety Reporting (9 pgs)
				(2) IND Annual Reports (8 pgs)
				(3) Post-Marketing Safety Reporting for Drugs and Biologics: Responsibilities (11 pgs)
				(4) Post-Marketing Safety Reporting for Drugs and Biologics: Content (11 pgs)
				(5) Validation of Electronic AE Data Capture Systems (6 pgs)
				(6) Data Monitoring Committee (6 pgs)
				(7) Statistical Analysis of AE Data (6 pgs)
				(8) MedDRA Coding of AE Data (4 pgs)
18		A Survey of Medical Device Adverse Event Reporting Requirements	A summary of FDA’s regulations about medical device AE reporting. How to improve reporting compliance. Includes 9 SOPs.	(1) PMA Safety Reporting (4 pgs)
				(2) MDR Requirements for Device User Facilities ( 4 pgs)
				(3) MDR Requirements for Device Importers (4 pgs)
				(4) MDR Requirements for Device Manufacturers (5 pgs)
				(5) Medical Device Complaint Records (5 pgs)
				(6) Validation of Electronic AE Data Capture Systems (6 pgs)
				(7) Data Monitoring Committees (6 pgs)
				(8) Statistical Analysis of AE Data (6 pgs)
				(9) MedDRA Coding of AE Data (4 pgs)
		(7) Requirements for Entering Data Into ClinicalTrials.gov
19		Understanding the Requirements for Entering Protocol Data into ClinialTrials.gov	Understanding the new requirement to enter study protocols data into the ClinicalTrials.gov web site.	No SOPs
20		Understanding the Requirements for Entering Clinical Trials Results into ClinialTrials.gov	A discussion of the requirements of all FDA regulated companies to enter clinical trial results into www.CinicalTrials.gov
21		Implications and Key Points About the Certification of Compliance – 30 minute update	A 30-minute update discussing FDA’s requirement for submissions to include a Certification of Compliance (Form FDA-364) confirming that protocol information has been entered into www.CinicalTrials.gov.	No SOPs
22		FDA’s New Definition of an “Applicable Trial”	A 30-Minute Update that reviews the content of FDA’s December 8, 2008 document intended to explain the agency’s interpretation of an “applicable clinical trial”, a study whose protocol and results must be entered into ClinicalTrials.gov

Table 3 of 3. Four Methods for Delivering Training
	Method	Advantages	Costs
1	Audioconference. Dr. Sharlin and one or more customer locations worldwide dial into an 800 number. Can use Skype for international locations.	Easy to participate. Only a phone is needed. (2) Fast, requires only 90 minutes. 70-minute presentation, 20 minutes for Q&A. (3) Interactive. Typical handout is 60 pages.	One connect line = One Connect fee = Unlimited Listeners. In a conference room setting-a speaker phone can be used—likewise at a larger sized auditorium. In both CASES- the number of people ATTENDING the audio conference is NOT COUNTED and the same cost applies whether at a conference room or auditorium.
2	Video conferencing. Dr. Sharlin is shown on a video webcam – two-way voice communication via Skype. SmartInspect option is available where wearable , wireless mobility is required, i.e. touring clinical trial or SMO sites, Computer facilities, Quality Control laboratories, etc.	More compelling presentation than an audioconference. (2) Interactive while visual	Same as Audio Conference Fees
3	On-site Instructor-led class	Most effective learning experience (2) More opportunities to ask question (3) More concentrated learning. (4) Usually present 2 to 4 topics in a day when teaching onsite.	On a case by case basis depending on topic, duration, location
4	30-min update	Quick delivery about important, “must know” topics.	Same as Audio or Video Conference Charges

Table 1 of 3. Summary of Dr. Sharlin’s Training Classes

Description

(1) Part 11 Compliance

(2) SOPs

(3) Regulatory Affairs

(4) Statistical Analysis

(5) SAS Programming

(6) Adverse Event Reporting

(7) Requirements for Entering Data Into ClinicalTrials.gov

Table 3 of 3. Four Methods for Delivering Training