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Industry: FDA Compliance

LiveWebinars

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Recorded Session

FDA Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data Integrity
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By: Carolyn Troiano | Recorded Session

Duration: 90 Minutes

How to Prepare For and Host a FDA Inspection and Respond to 483's
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By: Edwin Waldbusser | Recorded Session

Duration: 60 Minutes

From Challenges to Compliance: Understanding Dietary Supplement Oversight by the FDA
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By: Meredith Crabtree | Recorded Session

Duration: 90 Minutes

FDA Regulation of Artificial Intelligence/ Machine Learning
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By: Edwin Waldbusser | Recorded Session

Duration: 60 Minutes

Excel Spreadsheets; Develop and Validate for 21 CFR Part 11 Compliance
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By: David Nettleton | Recorded Session

Duration: 75 Minutes

FDA Compliance And Laboratory Computer System Validation
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By: Carolyn Troiano | Recorded Session

Duration: 90 Minutes

ChatGPT and Project Management: Leveraging AI for Project Management Excellence
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By: Charles H. Paul | Recorded Session

Duration: 90 Minutes

FDA Recommendations for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
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By: Rachelle D Souza | Recorded Session

Duration: 75 Minutes

Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers
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By: Kelly Thomas | Recorded Session

Duration: 90 Minutes

Human Factors Usability Studies Following ISO 62366 and FDA Guidance
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By: Edwin Waldbusser | Recorded Session

Duration: 60 Minutes

SOPs - How to Write Them to Satisfy those Inspectors
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By: Meredith Crabtree | Recorded Session

Duration: 60 Minutes

The 6 Most Common Problems in FDA Software Validation and Verification
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By: David Nettleton | Recorded Session

Duration: 120 Minutes

21 CFR Part 11 - Compliance for Electronic Records and Signatures
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By: Edwin Waldbusser | Recorded Session

Duration: 60 Minutes

Implementing an Effective Human Error Reduction Program
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By: Ginette M. Collazo | Recorded Session

Duration: 90 Minutes

Performance of Root Cause Analysis, CAPA, and Effectiveness Checks
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By: Meredith Crabtree | Recorded Session

Duration: 90 Minutes

2-Hour Virtual Seminar on the 6 Most Common Problems in FDA Software Validation and Verification
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By: David Nettleton | Recorded Session

Duration: 120 Minutes

Zero Acceptance Sampling to Reduce Inspection Costs
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By: William A. Levinson | Recorded Session

Duration: 90 Minutes

Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
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By: Kelly Thomas | Recorded Session

Duration: 90 Minutes

Setting up Quality System for FDA Regulated Products: Tips and Tricks for your Regulatory Compliance
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By: Meena Chettiar | Recorded Session

Duration: 60 Minutes

Best Practices in Complaint Management for Regulatory Compliance and Customer Retention
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By: Jeff Kasoff | Recorded Session

Duration: 60 Minutes

Ensuring Safe and Effective Pharmaceutical Products: A Comprehensive Guide to ICH Q9 (R1) Quality Risk Management in the Pharmaceutical Industry
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By: Meredith Crabtree | Recorded Session

Duration: 90 Minutes

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
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By: Carolyn Troiano | Recorded Session

Duration: 90 Minutes

Navigating FDA Inspections: From SOP to 483
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By: Jeff Kasoff | Recorded Session

Duration: 60 Minutes

Clinical Trial Systems: The Trial Master File (TMF) and Electronic Trial Master File (eTMF)
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By: Carolyn Troiano | Recorded Session

Duration: 90 Minutes

Supplier Management: Overcoming Challenges and Exploring Opportunities
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By: Jeff Kasoff | Recorded Session

Duration: 60 Minutes

Implementing a Robust Change Control Program - Key Elements for Process and Documentation Compliance
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By: Kelly Thomas | Recorded Session

Duration: 90 Minutes

Writing Effective 483 and Warning Letter Responses
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By: Kelly Thomas | Recorded Session

Duration: 90 Minutes

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
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By: Carolyn Troiano | Recorded Session

Duration: 60 Minutes

Aseptic Process Validation: Top-Tips for Compliance and Success
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By: Kelly Thomas | Recorded Session

Duration: 90 Minutes

Analytical Method Validation and Transfer Course
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By: Kelly Thomas | Recorded Session

Duration: 90 Minutes

FDA Compliance and Clinical Trial Computer System Validation
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By: Carolyn Troiano | Recorded Session

Duration: 90 Minutes

FDA current recommendations related to timely initiation of and responses to recalls
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By: Meredith Crabtree | Recorded Session

Duration: 75 Minutes

How to implement an effective Human Error Investigation Program
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By: Ginette M. Collazo | Recorded Session

Duration: 90 Minutes

Supervising a Human Error Free Environment: You can do a Lot More than you Think
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By: Ginette M. Collazo | Recorded Session

Duration: 90 Minutes

FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control
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By: Kelly Thomas | Recorded Session

Duration: 90 Minutes

Bad Standard Operating Procedures (SOPs) - Bad Training: Garbage In, Garbage Out
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By: Michael Esposito | Recorded Session

Duration: 90 Minutes

Data Governance for Computer Systems Regulated by FDA
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By: Carolyn Troiano | Recorded Session

Duration: 60 Minutes

FDA 21 CFR Part 11
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By: Willi Ramseier | Recorded Session

Duration: 60 Minutes

Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success
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By: Michael Esposito | Recorded Session

Duration: 90 Minutes

Data Governance for Computer Systems Regulated by FDA
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By: Carolyn Troiano | Recorded Session

Duration: 60 Minutes

FDA Case Scenarios - Best Practices for Managing Inspection Situations
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By: Danielle DeLucy | Recorded Session

Duration: 60 Minutes

Data Governance for Computer Systems Regulated by FDA
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By: Carolyn Troiano | Recorded Session

Duration: 90 Minutes

The FDA Inspection: Preparation, Performance and Follow-Up
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By: Jeff Kasoff | Recorded Session

Duration: 75 Minutes

FDAs Recent Clarification on Guidance for Managing Data Integrity for Regulated Computer Systems
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By: Carolyn Troiano | Recorded Session

Duration: 60 Minutes

Packaging and Labeling in Pharmaceutical Product Development - Best Practices
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By: Michael Esposito | Recorded Session

Duration: 90 Minutes

The 6 Most Common Problems in FDA Software Validation and Verification Computer System Validation Step-by-Step
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By: Carolyn Troiano | Recorded Session

Duration: 90 Minutes

Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices
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By: Susanne Manz | Recorded Session

Duration: 90 Minutes

21 CFR Part 11 Conformance for Medical Devices
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By: Edwin Waldbusser | Recorded Session

Duration: 90 Minutes

FDA s New Import Program for 2019
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By: Casper E Uldriks | Recorded Session

Duration: 60 Minutes

Using Learning Management Systems (LMS) to Develop Pharma Training: Rewards & Challenges
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By: Michael Esposito | Recorded Session

Duration: 90 Minutes

Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations
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By: Dr. Loren Gelber | Recorded Session

Duration: 90 Minutes

FDA's Enforcement Strategy for Mobile Medical Applications
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By: J.Lawrence Stevens | Recorded Session

Duration: 60 Minutes

Food Safety And Quality In Home Food Delivery
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By: Dr. John Ryan holds | Recorded Session

Duration: 60 Minutes