FDA Regulation of Artificial Intelligence/ Machine Learning

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

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

Writing Effective 483 and Warning Letter Responses

Navigating FDA Inspections: From SOP to 483

ChatGPT and Project Management: Leveraging AI for Project Management Excellence

21 CFR Part 11 - Compliance for Electronic Records and Signatures

2-Hour Virtual Seminar on the 6 Most Common Problems in FDA Software Validation and Verification

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

Complaint Handling and Management: From Receipt to Trending

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

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

Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

Human Factors Usability Studies Following ISO 62366 and FDA Guidance

FDA Compliance And Laboratory Computer System Validation

Data Integrity – In compliance with CSA, 21 CFR Part 11, SaaS/Cloud and EU GDPR

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

SOPs - How to Write Them to Satisfy those Inspectors

Implementing an Effective Human Error Reduction Program

Performance of Root Cause Analysis, CAPA, and Effectiveness Checks

Zero Acceptance Sampling to Reduce Inspection Costs

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

Best Practices in Complaint Management for Regulatory Compliance and Customer Retention

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

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

Supplier Management: Overcoming Challenges and Exploring Opportunities

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

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

Aseptic Process Validation: Top-Tips for Compliance and Success

Analytical Method Validation and Transfer Course

FDA Compliance and Clinical Trial Computer System Validation

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

How to implement an effective Human Error Investigation Program

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

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

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

Data Governance for Computer Systems Regulated by FDA

FDA 21 CFR Part 11

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

Data Governance for Computer Systems Regulated by FDA

FDA Case Scenarios - Best Practices for Managing Inspection Situations

Data Governance for Computer Systems Regulated by FDA

The FDA Inspection: Preparation, Performance and Follow-Up

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

Packaging and Labeling in Pharmaceutical Product Development - Best Practices

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

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

21 CFR Part 11 Conformance for Medical Devices

FDA s New Import Program for 2019

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

Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations

FDA's Enforcement Strategy for Mobile Medical Applications

Food Safety And Quality In Home Food Delivery