426 North Jennings Street Hawthorne, CA 90250 +1-661-336-9555 info@instructorsclub.com

Industry: FDA Compliance

ChatGPT and Project Management: Leveraging AI for Project Management Excellence
Instructor: Charles H. Paul
Date: Sept. 9, 2025
Time: 12:00 PM PDT | 03:00 PM EDT
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Recorded Session

2-Hour Virtual Seminar on the 6 Most Common Problems in FDA Software Validation and Verification
Instructor: David Nettleton
Date: Aug. 20, 2025
Time: 10:00 AM PDT | 01:00 PM EDT
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FDA Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data Integrity
Instructor: Carolyn Troiano
Date: April 21, 2025
Time: 12:00 PM PDT | 03:00 PM EDT
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How to Prepare For and Host a FDA Inspection and Respond to 483's
Instructor: Edwin Waldbusser
Date: April 10, 2025
Time: 10:00 AM PDT | 01:00 PM EDT
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From Challenges to Compliance: Understanding Dietary Supplement Oversight by the FDA
Instructor: Meredith Crabtree
Date: March 21, 2025
Time: 12:00 PM PDT | 03:00 PM EDT
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FDA Regulation of Artificial Intelligence/ Machine Learning
Instructor: Edwin Waldbusser
Date: March 21, 2025
Time: 10:00 AM PDT | 01:00 PM EDT
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Excel Spreadsheets; Develop and Validate for 21 CFR Part 11 Compliance
Instructor: David Nettleton
Date: March 18, 2025
Time: 12:00 PM PDT | 03:00 PM EDT
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FDA Compliance And Laboratory Computer System Validation
Instructor: Carolyn Troiano
Date: March 17, 2025
Time: 12:00 PM PDT | 03:00 PM EDT
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FDA Recommendations for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
Instructor: Rachelle D Souza
Date: March 12, 2025
Time: 10:00 AM PDT | 01:00 PM EDT
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Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers
Instructor: Kelly Thomas
Date: March 12, 2025
Time: 12:00 PM PDT | 03:00 PM EDT
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Human Factors Usability Studies Following ISO 62366 and FDA Guidance
Instructor: Edwin Waldbusser
Date: March 11, 2025
Time: 10:00 AM PDT | 01:00 PM EDT
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SOPs - How to Write Them to Satisfy those Inspectors
Instructor: Meredith Crabtree
Date: March 10, 2025
Time: 12:00 PM PDT | 03:00 PM EDT
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The 6 Most Common Problems in FDA Software Validation and Verification
Instructor: David Nettleton
Date: Feb. 20, 2025
Time: 12:00 PM PDT | 03:00 PM EDT
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21 CFR Part 11 - Compliance for Electronic Records and Signatures
Instructor: Edwin Waldbusser
Date: Feb. 11, 2025
Time: 10:00 AM PDT | 01:00 PM EDT
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Implementing an Effective Human Error Reduction Program
Instructor: Ginette M. Collazo
Date: Feb. 6, 2025
Time: 10:00 AM PDT | 01:00 PM EDT
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Performance of Root Cause Analysis, CAPA, and Effectiveness Checks
Instructor: Meredith Crabtree
Date: Jan. 27, 2025
Time: 12:00 PM PDT | 03:00 PM EDT
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Zero Acceptance Sampling to Reduce Inspection Costs
Instructor: William A. Levinson
Date: Jan. 14, 2025
Time: 12:00 PM PDT | 03:00 PM EDT
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Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
Instructor: Kelly Thomas
Date: Dec. 2, 2024
Time: 12:00 PM PDT | 03:00 PM EDT
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Setting up Quality System for FDA Regulated Products: Tips and Tricks for your Regulatory Compliance
Instructor: Meena Chettiar
Date: Sept. 26, 2024
Time: 12:00 PM PDT | 03:00 PM EDT
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Best Practices in Complaint Management for Regulatory Compliance and Customer Retention
Instructor: Jeff Kasoff
Date: Sept. 23, 2024
Time: 12:00 PM PDT | 03:00 PM EDT
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Ensuring Safe and Effective Pharmaceutical Products: A Comprehensive Guide to ICH Q9 (R1) Quality Risk Management in the Pharmaceutical Industry
Instructor: Meredith Crabtree
Date: Sept. 23, 2024
Time: 12:00 PM PDT | 03:00 PM EDT
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Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
Instructor: Carolyn Troiano
Date: Sept. 19, 2024
Time: 12:00 PM PDT | 03:00 PM EDT
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Navigating FDA Inspections: From SOP to 483
Instructor: Jeff Kasoff
Date: July 17, 2024
Time: 12:00 PM PDT | 03:00 PM EDT
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Clinical Trial Systems: The Trial Master File (TMF) and Electronic Trial Master File (eTMF)
Instructor: Carolyn Troiano
Date: May 31, 2024
Time: 12:00 PM PDT | 03:00 PM EDT
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Supplier Management: Overcoming Challenges and Exploring Opportunities
Instructor: Jeff Kasoff
Date: May 2, 2024
Time: 10:00 AM PDT | 01:00 PM EDT
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Implementing a Robust Change Control Program - Key Elements for Process and Documentation Compliance
Instructor: Kelly Thomas
Date: April 22, 2024
Time: 10:00 AM PDT | 01:00 PM EDT
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Writing Effective 483 and Warning Letter Responses
Instructor: Kelly Thomas
Date: Dec. 19, 2023
Time: 12:00 PM PDT | 03:00 PM EDT
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21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
Instructor: Carolyn Troiano
Date: Oct. 30, 2023
Time: 12:00 PM PDT | 03:00 PM EDT
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Aseptic Process Validation: Top-Tips for Compliance and Success
Instructor: Kelly Thomas
Date: Oct. 30, 2023
Time: 10:00 AM PDT | 01:00 PM EDT
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Analytical Method Validation and Transfer Course
Instructor: Kelly Thomas
Date: Oct. 26, 2023
Time: 10:00 AM PDT | 01:00 PM EDT
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FDA Compliance and Clinical Trial Computer System Validation
Instructor: Carolyn Troiano
Date: Oct. 4, 2023
Time: 10:00 AM PST | 01:00 PM EST
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FDA current recommendations related to timely initiation of and responses to recalls
Instructor: Meredith Crabtree
Date: Sept. 25, 2023
Time: 10:00 AM PDT | 01:00 PM EDT
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How to implement an effective Human Error Investigation Program
Instructor: Ginette M. Collazo
Date: Sept. 12, 2023
Time: 10:00 AM PDT | 01:00 PM EDT
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Supervising a Human Error Free Environment: You can do a Lot More than you Think
Instructor: Ginette M. Collazo
Date: Aug. 24, 2023
Time: 10:00 AM PDT | 01:00 PM EDT
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FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control
Instructor: Kelly Thomas
Date: March 8, 2023
Time: 12:00 PM PST | 03:00 PM EST
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Bad Standard Operating Procedures (SOPs) - Bad Training: Garbage In, Garbage Out
Instructor: Michael Esposito
Date: Jan. 31, 2023
Time: 10:00 AM PST | 01:00 PM EST
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Data Governance for Computer Systems Regulated by FDA
Instructor: Carolyn Troiano
Date: Dec. 8, 2022
Time: 10:00 AM PST | 01:00 PM EST
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FDA 21 CFR Part 11
Instructor: Willi Ramseier
Date: Sept. 20, 2022
Time: 10:00 AM PDT | 01:00 PM EDT
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Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success
Instructor: Michael Esposito
Date: Aug. 12, 2022
Time: 10:00 AM PDT | 01:00 PM EDT
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Data Governance for Computer Systems Regulated by FDA
Instructor: Carolyn Troiano
Date: April 19, 2022
Time: 10:00 AM PST | 01:00 PM EST
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FDA Case Scenarios - Best Practices for Managing Inspection Situations
Instructor: Danielle DeLucy
Date: March 30, 2022
Time: 12:00 PM PST | 03:00 PM EST
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Data Governance for Computer Systems Regulated by FDA
Instructor: Carolyn Troiano
Date: Feb. 8, 2022
Time: 10:00 AM PST | 01:00 PM EST
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The FDA Inspection: Preparation, Performance and Follow-Up
Instructor: Jeff Kasoff
Date: Jan. 21, 2022
Time: 12:00 PM PST | 03:00 PM EST
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FDAs Recent Clarification on Guidance for Managing Data Integrity for Regulated Computer Systems
Instructor: Carolyn Troiano
Date: Feb. 20, 2020
Time: 10:00 AM PST | 01:00 PM EST
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Packaging and Labeling in Pharmaceutical Product Development - Best Practices
Instructor: Michael Esposito
Date: Feb. 11, 2020
Time: 12:00 PM PST | 03:00 PM EST
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The 6 Most Common Problems in FDA Software Validation and Verification Computer System Validation Step-by-Step
Instructor: Carolyn Troiano
Date: Dec. 4, 2019
Time: 10:00 AM PST | 01:00 PM EST
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Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices
Instructor: Susanne Manz
Date: Aug. 22, 2019
Time: 10:00 AM PST | 01:00 PM EST
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21 CFR Part 11 Conformance for Medical Devices
Instructor: Edwin Waldbusser
Date: June 27, 2019
Time: 10:00 AM PST | 01:00 PM EST
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FDA s New Import Program for 2019
Instructor: Casper E Uldriks
Date: May 6, 2019
Time: 10:00 AM PST | 01:00 PM EST
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Using Learning Management Systems (LMS) to Develop Pharma Training: Rewards & Challenges
Instructor: Michael Esposito
Date: Feb. 8, 2019
Time: 01:00 PM EST | 10:00 AM PST
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Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations
Instructor: Dr. Loren Gelber
Date: Nov. 13, 2018
Time: 03:00 PM EST| 12:00 PM PST
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FDA's Enforcement Strategy for Mobile Medical Applications
Instructor: J.Lawrence Stevens
Date: Sept. 28, 2018
Time: 03:00 PM EST| 12:00 PM PST
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Food Safety And Quality In Home Food Delivery
Instructor: Dr. John Ryan holds
Date: Jan. 1, 1
Time: 01:00 PM EST| 10:00 AM PST
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