WEBINARS - HRPF landing

Risk Management and Impact Assessments in Change Control

Statistical Process Control (SPC) and Control Charts for Laboratory Compliance

Statistical Process Control (SPC) and Control Charts - In Accordance with Latest FDA Expectations

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

The Supervisor's Guide to a Human Error-Free Environment

Practical Implementation of Pharmaceutical Quality Risk Management (QRM)

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.