WEBINARS

3-Hour Virtual Seminar on Bad Standard Operating Procedures (SOPs) – Bad Training: Garbage In, Garbage Out

Developing Effective Post Market Surveillance and Complaint Handling Requirements (Interrelationship with CAPA, Change Control, Adverse Event Reporting and Recalls)

This article discusses the significance of developing effective post-market surveillance and complaint handling requirements and their interrelationship with CAPA, change control, adverse event reporting, and recalls.

Project Management For Non-Project Managers Series - Role Of Project Management In Quality Planning Throughout The Medical Device Project Lifecycle

Validating and Auditing Cloud, SaaS, IaaS, PaaS Systems - Tech & Validation Trends for FDA Compliance

This article explores the latest trends in technology and validation processes for ensuring FDA compliance in Cloud, SaaS, IaaS, and PaaS systems.

FDA's Total Product Life Cycle Approach to In Vitro Diagnostic Products (IVD's)

Excel Spreadsheets - Ensuring Data Integrity and 21 CFR Part 11 Compliance

Explore methods for ensuring data integrity and meeting 21 CFR Part 11 standards in Excel Spreadsheets.

Avoid Warning Letters in View of the U.S. FDA's Stated Goal

Understand the implications of receiving a warning letter from the U.S. FDA and how to prevent it.

Regulatory Audit Preparedness

Understanding Supply Chain Management Concepts

An in-depth analysis of key concepts related to supply chain management.

Understanding and Implementing a Quality by Design (QbD) Program

This article provides an overview of the principles and benefits of Quality by Design (QbD) program in pharmaceutical development.