Teleconference Audio CDs

Click on a name to see a list of titles available for that speaker.
Speaker Subjects Addressed
Akelewicz, Frances Risk Management, Device Corrections and Removals
Andrews, Judith Device Quality Systems
Alschuler, Liora Product Labeling Production
Basile, Ed 510(k)s
Bills, Edwin Risk Management
Bentivoglio, John Pharmaceutical Promotion
Bonforte, Link Risk Management
Chamberlain, Richard Clinical Data Management
Cobbold, Egan Device Regulations - Canada
Corcoran, Julie Pharmaceutical Promotion
DeRisio, Rick CAPA
Dion, Denise Internal Audits
Dolan, Alf Devices, ISO 14971
Eden, Alison Informed Consent
Elengold, Mark Internal FDA Documents
Frueh, Felix Pharmacogenomics
Garris, Cindy Small Business Certification
Gelberg, Alan Adverse Event Inspections
Goldmann, Bonnie Biomarkers in drug development
Gollinger, Jerry Risk Management
Gottlieb, Scott FDA Legal
Grezlak, Donna Informed Consent
Hamrell, Michael Clinical Trials, Fraud, Detecting Clinical Misconduct
Handzo, Jim Device Corrections and Removals
Hanson, Karmen Pharmaceutical Promotion
Hemeon-Heyer, Sheila Device Quality Systems
Horacek, Chris Device Advertising and Promotion
Hornick, John Protecting Your Trade Secrets
Hirigoyenberry-Lanson, Fabienne EU & Medical Devices
Hocker, Sue Informed Consent
Howard, Lindsey Risk Management
Jacobs, Sue Internal Audits
Jarcho, Daniel FDA Legal
Kaiser, Lisa Device Corrections and Removals
Kalter, Sandy C. Device Advertising and Promotion
Kimmelman, Ed ISO 13485
King & Spalding - a panel of experts FDAAA 2007, Devices
Klasmeier, Coleen FDA Legal, Device Advertising and Promotion
Lovett, Linda CAPA
Mastrangelo, Stan Devices, ISO 14971
McCarthy, David Drug Export
Miles, Ken FDA Inspections
Morton, Michael Informed Consent
Niedelman, Steven FDA Compliance Issues
O'Flaherty, Neil Device Advertising and Promotion
Olivier, Dan CAPA
O'Reilly, James FDA Practice and Procedure
Palmer, Michael Electronic NDAs, Structured Product Labels, CDISC
Pellerite, Wally CDRH
Petrin, Jurij International Regulatory
Phillips, Phil Device Evaluation
Rawlins, Andrew Medical Devices
Reeves, Nikki Pharmaceutical Promotion, Device Advertising and Promotion
Reilly, Susan Internal Audits
Rosen, David FDA's Orange Book
Rudolph, Harvey Medical Device Risk Management
Schiff, Kenneth ICH/ISO
Scott, Jody 510(k)s
Serge, Marian Informed Consent
Shapiro, Jeff Device Advertising and Promotion
Sharlin, Joshua SOPs, SAS, Part 11, Safety Reporting, Electronic NDAs, NDA Review, Reviewers, and Submissions, Statistics, Computerized Systems in Clinical Trials, FDA Legal
Shelton, Deborah M. Device Advertising and Promotion
Sheridan, Robert 510(k)s
Singer, Nancy 510(k)s, Devices, ISO 14971, Internal Audits, Risk Management, FDA Legal, Pharmaceutical Promotion, Device Advertising and Promotion, Device Corrections and Removals, CAPA, Informed Consent
Spiller, Bob Violative Inspection & FDA Actions
Sprinkle, Les Informed Consent
Stark, Nancy Clinical Databases, Part 11; ICH/ISO
Taggart, Mike Device Advertising and Promotion
Terman, Steve 510(k)s
Troy, Daniel E. FDA Legal
Uldricks, Cap Device Corrections and Removals
Usdin, Steve FDA Legal
Warren, Ronald S. Human Tissue-Based Combination Products
Weagraff, Pam Risk Management
Welch, Jan CAPA