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Industry: FDA Compliance

LIVE WEBINARS

FDA Compliance

By: Edwin Waldbusser

FDA Regulation of Artificial Intelligence/ Machine Learning

19 November (Tuesday)

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FDA Compliance

By: David Nettleton

Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR

20 November (Wednesday)

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FDA Compliance

By: Meredith Crabtree

SOPs - How to Write Them to Satisfy those Inspectors

21 November (Thursday)

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FDA Compliance

By: Carolyn Troiano

FDA Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data Integrity

06 December (Friday)

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RECORDED SESSION

FDA Compliance

By: Dr. John Ryan holds

Food Safety And Quality In Home Food Delivery

60 Minutes

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FDA Compliance

By: J.Lawrence Stevens

FDA's Enforcement Strategy for Mobile Medical Applications

60 Minutes

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FDA Compliance

By: Dr. Loren Gelber

Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations

90 Minutes

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FDA Compliance

By: Michael Esposito

Using Learning Management Systems (LMS) to Develop Pharma Training: Rewards & Challenges

90 Minutes

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FDA Compliance

By: Casper E Uldriks

FDA s New Import Program for 2019

60 Minutes

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FDA Compliance

By: Edwin Waldbusser

21 CFR Part 11 Conformance for Medical Devices

90 Minutes

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FDA Compliance

By: Susanne Manz

Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices

90 Minutes

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FDA Compliance

By: Carolyn Troiano

The 6 Most Common Problems in FDA Software Validation and Verification Computer System Validation Step-by-Step

90 Minutes

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FDA Compliance

By: Michael Esposito

Packaging and Labeling in Pharmaceutical Product Development - Best Practices

90 Minutes

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FDA Compliance

By: Carolyn Troiano

FDAs Recent Clarification on Guidance for Managing Data Integrity for Regulated Computer Systems

60 Minutes

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FDA Compliance

By: Jeff Kasoff

The FDA Inspection: Preparation, Performance and Follow-Up

75 Minutes

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FDA Compliance

By: Carolyn Troiano

Data Governance for Computer Systems Regulated by FDA

90 Minutes

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FDA Compliance

By: Danielle DeLucy

FDA Case Scenarios - Best Practices for Managing Inspection Situations

60 Minutes

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FDA Compliance

By: Carolyn Troiano

Data Governance for Computer Systems Regulated by FDA

60 Minutes

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FDA Compliance

By: Michael Esposito

Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success

90 Minutes

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FDA Compliance

By: Willi Ramseier

FDA 21 CFR Part 11

60 Minutes

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FDA Compliance

By: Carolyn Troiano

Data Governance for Computer Systems Regulated by FDA

60 Minutes

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FDA Compliance

By: Michael Esposito

Bad Standard Operating Procedures (SOPs) - Bad Training: Garbage In, Garbage Out

90 Minutes

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FDA Compliance

By: Kelly Thomas

FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control

90 Minutes

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FDA Compliance

By: Ginette M. Collazo

Supervising a Human Error Free Environment: You can do a Lot More than you Think

90 Minutes

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FDA Compliance

By: Ginette M. Collazo

How to implement an effective Human Error Investigation Program

90 Minutes

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FDA Compliance

By: Meredith Crabtree

FDA current recommendations related to timely initiation of and responses to recalls

75 Minutes

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FDA Compliance

By: Carolyn Troiano

FDA Compliance and Clinical Trial Computer System Validation

90 Minutes

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FDA Compliance

By: Kelly Thomas

Analytical Method Validation and Transfer Course

90 Minutes

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FDA Compliance

By: Kelly Thomas

Aseptic Process Validation: Top-Tips for Compliance and Success

90 Minutes

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FDA Compliance

By: Carolyn Troiano

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

60 Minutes

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FDA Compliance

By: Kelly Thomas

Writing Effective 483 and Warning Letter Responses

90 Minutes

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FDA Compliance

By: William A. Levinson

Zero Acceptance Sampling to Reduce Inspection Costs

90 Minutes

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FDA Compliance

By: Kelly Thomas

Implementing a Robust Change Control Program - Key Elements for Process and Documentation Compliance

90 Minutes

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FDA Compliance

By: Jeff Kasoff

Supplier Management: Overcoming Challenges and Exploring Opportunities

60 Minutes

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FDA Compliance

By: Carolyn Troiano

Clinical Trial Systems: The Trial Master File (TMF) and Electronic Trial Master File (eTMF)

90 Minutes

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FDA Compliance

By: Kelly Thomas

Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

90 Minutes

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FDA Compliance

By: Kelly Thomas

Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers

90 Minutes

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FDA Compliance

By: Edwin Waldbusser

How to Prepare For and Host a FDA Inspection and Respond to 483's

60 Minutes

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FDA Compliance

By: Ginette M. Collazo

Implementing an Effective Human Error Reduction Program

90 Minutes

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FDA Compliance

By: Jeff Kasoff

Navigating FDA Inspections: From SOP to 483

60 Minutes

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FDA Compliance

By: Rachelle D Souza

FDA Recommendations for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions

75 Minutes

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FDA Compliance

By: Carolyn Troiano

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

90 Minutes

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FDA Compliance

By: Meredith Crabtree

Ensuring Safe and Effective Pharmaceutical Products: A Comprehensive Guide to ICH Q9 (R1) Quality Risk Management in the Pharmaceutical I…

90 Minutes

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FDA Compliance

By: Jeff Kasoff

Best Practices in Complaint Management for Regulatory Compliance and Customer Retention

60 Minutes

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FDA Compliance

By: Meena Chettiar

Setting up Quality System for FDA Regulated Products: Tips and Tricks for your Regulatory Compliance

60 Minutes

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FDA Compliance

By: Meredith Crabtree

From Challenges to Compliance: Understanding Dietary Supplement Oversight by the FDA

90 Minutes

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FDA Compliance

By: Edwin Waldbusser

Human Factors Usability Studies Following ISO 62366 and FDA Guidance

60 Minutes

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FDA Compliance

By: Meredith Crabtree

Performance of Root Cause Analysis, CAPA, and Effectiveness Checks

90 Minutes

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FDA Compliance

By: Carolyn Troiano

FDA Compliance And Laboratory Computer System Validation

90 Minutes

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