Featured Product In Inspections and Audits
Calculating Sample Size to Satisfy FDA Expectations
$199.00
Regulatory authorities require risk-based sample sizes that have a sound statistical foundation. Ensure your organization can meet their expectations with Calculating Sample Size to Satisfy FDA Expectations. Read More
Inspections and Audits
PDUFA and BsUFA Reauthorization Developments: What Regulatory, Compliance and Quality Professionals Need to Know – Webinar Recording/Transcript
$287.00
The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval – Webinar Recording/Transcript
$287.00
Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections – Webinar Recording/Transcript
$287.00
Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis – Webinar Recording/Transcript
$337.00
Pharmaceutical Process Validation: Best Practices for Success – Webinar Recording/Transcript
$287.00
Gene & Cell Therapy Regulation: Comparability and Other New Developments – Webinar Recording/Transcript
$287.00
Recall Readiness: Dust Off Your SOPs, There’s a New Guidance in Town – Webinar Recording/Transcript
$287.00
FDA’s Alternative Inspection Tools: Expert Answers to Drug and Biologics Manufacturers’ Questions
$129.00
CDER’s Priorities for 2022: What You Must Know About New Guidance and Program Plans – Webinar Recording/Transcript
$287.00