SEMINARS
Upcoming In-person and Virtual Seminars by Ex-FDA and other regulatory experts.
Get Trained on - FDA Audits and Inspections, FDA’s GMP Expectations, Clinical Trials, Vendor Selection, FDA’s New Import Program, FDA Recalls, CAPA and more
21 CFR Part 11 Compliance for SaaS/Cloud Applications
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eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
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FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials
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An Interactive Workshop on Auditing and FDA Quality Management System (QMS) For Medical Devices Including In Vitro Diagnostic Medical Devices | Day 3
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The Regulations of OTC Drugs
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Microbial Contamination Control in Aseptic and Non-Sterile Manufacturing
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FDA's Quality System Regulation | Day 1
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Using Process Failure Mode & Effects Analysis (FMEA) to Identify and Manage Risks to Internal and External Customers
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I-9 and Immigration Enforcement Bootcamp: Employer Best Practices & Compliance
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Applied Statistics for Scientists and Engineers
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Implementing an Effective CAPA System: cGMP, Root Cause Analysis (RCA), Investigation and Risk Assessment
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Pharmaceutical Quality Management System (GMP Requirements, ICH Guidance, QbD, and USFDA/EMA Regulations)
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Pharmaceutical Quality Management System (GMP Requirements, ICH Guidance, QbD, and USFDA/EMA Regulations)
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Critical Vendor Risk Management
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How TGA, FDA & Other Regulatory Authorities Inspect Computerized Systems for Data Integrity
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HUMAN RESOURCES BOOT CAMP: Focus on developments in employment law including sexual harassment
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Building an AML/CTF Assurance Program
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Computer System Validation and 21 CFR Part 11 Compliance
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US Good Clinical Practice (GCP) Regulations and ICH GCP Guidelines
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The Challenges of an Effective Change Control Program and How to Address OOS Results
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