Audio Library 21 CFR Part 11 Electronic Records & cGMP Initiative Risk-Based Plans for Part-11 Compliance Data Security/Audit trails in Part 11-compliant Systems Beyond Network Validation: Qualifying Computer and Network Infrastructures Adverse Event Reporting Comparability Protocols Safety Reports on Human Drugs & Biologics Safety Action Plans: Regulatory Responses and Litigation Exposure IND/IDE Adverse Event Reporting: Requirements and Strategies Migrating to MedDRA: Critical Considerations Branded/Generic Drug Policy Issues with QT Interval Prolongation/Safety Pharmacology The Impact of On-Line QC on Manufacturing Overcoming Regulatory Issues Process Analytical Technology Who's Afraid of CAPAs? How The RX Industry Can Fight Counterfeit Drugs Fixing Hatch-Waxman: The Future of Market Exclusivity Extensions Off-label Promotions: Complying with FDA and SEC Anser-based-Submission (AbS): An Industry Companion Approach to FDA's QUestion-based-Review (QbR) Clinical Research ClinicalTrials.gov and FDAMA Section 113-Study Disclosure Regulatory Jeopardy: Clinical Investigations Are No Game Developing and Marketing Quality CRE Programs How to Prepare for FDA Audits in Clinical Studies Gaining FDA Approval with Monitoring & Auditing in Clinical Research Informed Consent: Principles and Practices The HIPAA Privacy Rule: Impact on Clinical Research Avoiding Financial Conflicts of Interest in Clinical Trials To GLP or Not to GLP: Perspectives from the Contracting Lab How to Prepare FDA Clinical Research Audits Computer Validation FDA's Emphasis on Risk Assessment in Validation Programmable Logic Controllers Change Control Configuration Management Software Testing to Reveal Errors Automated Compliance Systems Using Commercial Off the Shelf (COTS) SOPs in Existing IT Systems Auditing Clinical Data Validating Commercial Off-the-shelf ApplicationsManagement Systems Validating Computerized Drug Manufacturing Systems FDA Enforcement Root Cause Analysis: How to Benefit from Failures New USSC Sentencing Guidelines and Corporate Compliance Protocols and Strategies for Hosting FDA Investigators Root Cause Analysis FDA's New Warnings Preparing Effective Investigative Reports Understanding REACH How Foreign Firms Can Avoid Warning Letters and Import Detentions Impact of GMPs for Dietary Supplements Implement Corporate Compliance Programs FDA's New Warning Letters -- Bark, Bite, or Both? Improving Outcomes in Quality Risk-Management Through Training. Human Research Protections Pre-screeening and Case Identification Under HIPAA Beyond IRBs: Human Research Protection in the Post Gelsinger/Roche Era HIPPA Research Disclosures to Registries How to Reduce IRB-related risks in Clinical trials International Clinical Trials: Ethical and Legal Issues Ethical, Legal and Effective Patient Recruitment Prescription Drug Marketing Designing a Cost-Effective and Streamlined Cold Chain Process Auditing and Evaluation of Company Process and Procedures Integrating Risk Management into Quality Systems Rx Re-Importation & Medicare Reform Outcome Analysis for Regulatory Impact Assessment Promotional Interactions with Healthcare Providers Developing Compliant Web-based Rx Drug Promotions Structured Product Labeling Pharmacovigilance/ Risk Management Pharmacovilgilance/Risk Management Order Form Is there a scheduling conflict with one of our briefings? No problem — we record our briefings so you can listen in any time, any where. Available in audio cassette. Check our fax order form for discounts on past tapes.

Page last updated October 16, 2006

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