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Search Trainings
26 results
Recorded Webinar
Quality Management 101: An Enterprise Maintenance Professional's Guide
What are the basics of an enterprise maintenance-focused Quality Management System? This webinar will examine that question by means of the international standard, ISO 9001, the international standard for Quality Management Systems for all business or industri ...
- Basic & Intermediate
- 90 Mins
- John E. Lincoln
On-Demand Webinar
Data Integrity 21 CFR Part 11
The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing d ...
- Basic & Intermediate
- 90 Mins
- Kelly Thomas
Recorded Webinar
Medical Device Software Validation Meeting FDA Regulations
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are us ...
- Basic & Advanced
- 60 Mins
- Edwin Waldbusse
Recorded Webinar
FDA - ICH Guideline Q9 R1 on Quality Risk Management
The training session aims to provide participants with an understanding of the International Council for Harmonization (ICH) Q9 guideline, with a focus on the revised version, ICH Q9(R1). Participants will learn about the principles, concepts, and application ...
- Basic & Advanced
- 90 Mins
- Meredith Crabtr
Recorded Webinar
GMP overview for QC Laboratories
In the manufacture and quality control of medicinal products, compliance with the GMP rules is the decisive aspect for manufacturing high-quality products. For this reason, every staff member in the pharmaceutical industry has to be familiar with the basic GMP ...
- Basic & Intermediate
- 90 Mins
- Kelly Thomas
On-Demand Webinar
The US FDA's 21 CFR Part 11: Add-on Inspections
“All software, firmware, ladder logic, must be validated” – US FDA. Verification and validation requirements have always been part of the US FDA’s GMPs. Where does 21 CFR Part 11 fit in? Pt 11 “selective enforcement”? “Add on”? Companies still struggle with th ...
- Basic & Intermediate
- 90 Mins
- John E. Lincoln
On-Demand Webinar
Impact Assessment for Change Control
Attend this webinar to learn the importance of doing a complete impact assessment prior to implementation of changes under change control. Tools and techniques will be presented to aid in organizing and streamlining impact assessments.
- Intermediate
- 60 Mins
- Alan M Golden
Recorded Webinar
Validation Sampling Plans
This webinar will discuss setting up statistically justified sampling plans for process validation. Discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation w ...
- Intermediate
- 60 Mins
- Alan M Golden
Recorded Webinar
The Importance of Packaging and Labeling in Pharmaceutical Product Development
Occupying a critical position in the success or failure of any pharmaceutical product launch or revision, Packaging and Labeling form a bridge between the conception of a product and its realization and distribution. Their activities are also crucial for compl ...
- Basic & Intermediate
- 90 Mins
- Michael Esposit
Recorded Webinar
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
Establishing appropriate Quality Assurance metrics is important for several reasons. Metrics not only measure the health of your quality system, they have the ability to change behavior, drive quality culture and improve both individual and company performanc ...
- Basic & Intermediate
- 90 Mins
- Kelly Thomas