LIST OF Audio Conferences Delivered LIVE by Dr. Joshua Sharlin, Ph.D.


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Summary of Audioconferences

Sr.No

Topic

Number of Audioconferences

1

Part 11 Compliance 3 (1 - 3)

2

SOPs 2 (4 - 5)

3

Regulatory Affairs 11 (6 - 16)

4

Statistical Analysis 2 (17 - 18)

5

SAS Programming 5 (19 - 23)

6

Electronic Submissions 2 (24 - 25)

7

Medical Devices 1 (26)
Total 26


Audioconferences Developed and Presented by Sharlin Joshua
Title
(presentation date)
Description
SOPs
Part 11 Compliance

1

Implementing a Risk Based Approach to Part 11 Compliance (8Mar06) A review and discussion of FDA's risk assessment requirement for evaluating systems that support product quality, safety and record integrity. Includes 4 SOPs.
(1) Risk Assessment: Overview and Approach
(2) Risk Assessment: Part 11 Applicability
(3) Risk Assessment: Checklist Use

2

Computerized Systems Used In Clinical Trials: Improving your Compliance (7Jun07) A summary of new information in the latest (May 2007) version of the guidance, Computerized Systems Used in Clinical Trials and how to improve compliance based on this new information. No SOPs

3

Is Part 11 Going Away (12Aug03) An interpretation and discussion of the February 2003 FDA guidance, "Part 11, Electronic Records; Electronic Signatures - Scope and Application". Includes an explanation for why some Part 11 guidance were withdrawn. No SOPs
SOPs

4

Writing SOPs Part I: An Introduction (6Feb07) An overview of the how and why of writing SOPs. Includes FDA expectations and regulations. No SOPs

5

Writing SOPs Part II: Advanced Problems, Advanced Solutions (8Feb07) Advanced topics regarding the development, implementation and compliance of SOPs used by FDA regulated companies. Includes global SOPs, flowcharting and SOP deliverables. No SOPs
Regulatory Affairs

6

Clinical Information Strategy (24Apr07) How to learn more from legacy studies to support your current research. No SOPs

7

Annual Reports: SOPs for Developing Content That Meets FDA Requirements (6Dec06) 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 Ann ual Reports Required of Sponsors and Investigators Before Product Approval

(3) Device Ann ual Reports Required of A PMA Sponsor, Manufacturer or User Facility

(4) IND Ann ual Report

(5) Drug Post Approval Annual Reports

8

Survey of FDA Reviewer Training: Understanding Reviewer Strategies, Tools, & Techniques for Approving Your Paper or Electronic Submission (16Nov06) 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

Understanding FDA's New Package Insert Requirements for Drugs and Biologics (27Mar07) An overview of FDA's new requirements for prescription drug package inserts effective June 30, 2006. Includes 2 SOPs. (1)Determining When A Label Must Be in the New (2006) Format

(2) Format and Organization Requirements For The New (2006) Label

(2) Post-Marketing Safety Reporting for Drugs and Biologics: Content (8pgs)
10 Good Review Management: FDA's Internal Standards and Expectations of Industry (13Jul06) A discussion of standards and processes meant to improve; a) FDA performance, and b) the quality of submissions produced by regulated industry. No SOPs
11 Adverse Event Reporting SOPs for Drugs and Biologics (23May07) 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
(2) IND Annual Reports
(3) Post-Marketing Safety Reporting for Drugs and Biologics: Responsibilities
(4) Post-Marketing Safety Reporting for Drugs and Biologics: Content
(5) Validation of Electronic AE Data Capture Systems
(6) Data Monitoring Committee
(7) Statistical Analysis of AE Data
(8) MedDRA Coding of AE Data
12 What Needs To Be In A Product Submission: A FDA Reviewer's Perspective (8Mar07) 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
13 Report on FDA Meeting About Follow-On Proteins (i.e., Generic Biologics) (14Sep04) A 322 page report about the content and issues discussed by 32 speakers at a 1 ½ day meeting about generic biologics sponsored by FDA. No SOPs
14 FDA's New Safety Reporting Requirements: Complexities and Costs (29May03) An exploration and discussion of the 93-pages of proposed rules on "Safety Reporting Requirements for Human Drugs and Biological Products", published on 14March2003 in the Federal Register. No SOPs
15 The Common Technical Document (CTD): Easing Global Drug Approval (26Jun02) A discussion about understanding and using the CTD. No SOPs
16 Disagreeing With FDA: A Shot in the Arm or a Shot in the Foot (20Apr06) A review of the Utah Medical court case lost by FDA. An overview of options and strategies to use when there is a disagreement with a decision by FDA. No SOPs
Statistical Analysis
17 New Trends in Clinical Trial Design That Encourage FDA Approval (19Sep06) An overview of the basics for implementing adaptive design and Bayesian statistical analysis. Intended for non-statisticians. No SOPs
18 Avoiding Statistical Errors in Clinical Trials: Preparing for FDA Review (25May06) How to use statistics to improve the design, execution and analysis of clinical trials. Intended for non-statisticians. No SOPs
19 SAS Secrets Revealed, Part 1 of 2 (31Oct06) A discussion about understanding how SAS works, including the program data vector, SAS supervisor and compile time and execution time statements. No SOPs
20 SAS Secrets Revealed, Part 2 of 2 (2Nov06) 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
21 SOPs For SAS Programming: Tools For Part 11 Compliance (5Oct06) 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
(2) SAS Validation Overview
(3) SAS Requirements Specifications
(4) SAS High Level Study Design
(5) SAS Program Design
(6) SAS Database Specification
(7) SAS Directory Structure
(8) SAS Coding Conventions
(9) SAS Log Review
(10) SAS Change Control
(11) Debugging SAS Logic Errors
(12) SAS Testing
(13) Maintain SAS Installation
(14) Create SAS Transport Files
(15) SAS Program Risk Assessment
22 Testing SAS Programs: A Key Element of Part 11 Compliance (12Apr07) 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 Assessments
(2) SAS Log Review (8 pgs)
(3) SAS Testing (7 pgs)
(4) Debugging SAS Logic Errors
(5) SAS Change Control

23 Using Available Tools: How To Reduce Part 11 Compliance Costs for SAS Installation, Maintenance and Programming (16Nov04) How to use the free IQ/OQ tools provided by SAS Institute for product installation. A review of strategies for reducing the costs of SAS installation and maintenance. Includes 3 SOPs.

(1) Initial Installation of SAS IQ/OQ Tools
(2) Using the SAS IQ Tool
(3) Using the SAS OQ Tool (4 pgs)

Electronic Submissions
24 FDA Electronic Submissions: Part 1, Essential Requirements and Standards (1Feb05) Discussion about eSubs as information maps. How reviewers use eSubs. Also hypertext linking, data definition tables and the eCTD. No SOPs
25 Electronic Submissions: Will FDA Require eSubs & Outsource eSub Infrastructure (16Jan07) A summary of the December 18, 2006 public meeting Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management held at FDA in Rockville, Maryland. No SOPs
Medical Devices
26 Adverse Event Reporting SOPs for Medical Devices (30May07) A summary of FDA's regulations about medical device AE reporting. How to improve reporting compliance. Includes 9 SOPs. (1) PMA Safety Reporting
(2) MDR Requirements for Device User Facilities
(3) MDR Requirements for Device Importers
(4) MDR Requirements for Device Manufacturers
(5) Medical Device Complaint Records
(6) Validation of Electronic AE Data Capture Systems
(7) Data Monitoring Committees
(8) Statistical Analysis of AE Data
(9) MedDRA Coding of AE Data