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176 results
Recorded Webinar
The FDA Inspection from SOP to 483
This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including wh ...
- Intermediate
- 90 Mins
- Jose Mora
Recorded Webinar
Validation of GC/ GC-MS Methodologies
Instrumental gas chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation ...
- Intermediate
- 90 Mins
- John Fetzer
Recorded Webinar
Audit 101 - How to conduct an effective audit & what they don't tell you may happen during an audit
Auditing is a critical function in any organization, ensuring compliance, accuracy, and efficiency in various operations. While traditional auditor certification training provides a solid foundation in auditing principles, procedures, and standards, it often f ...
- Intermediate & Advan
- 90 Mins
- Meredith Crabtr
Recorded Webinar
HPLC Analytical Method Development and Validation
Instrumental liquid chromatography is an analysis widely used to determine purity, impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of ...
- Basic & Intermediate
- 60 Mins
- John Fetzer
Recorded Webinar
21 CFR Part 11 - Compliance for Electronic Records and Signatures
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in ...
- Basic & Advanced
- 60 Mins
- Edwin Waldbusse
Recorded Webinar
Corrective and Preventive Action (CAPA) - Principles of Lean Documents and Lean Configuration
The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and "push ...
- Intermediate
- 90 Mins
- Jose Mora
Recorded Webinar
Supervising a Human Error Free Environment: You can do a Lot More than you think
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allo ...
- Intermediate
- 90 Mins
- Ginette Collazo
Recorded Webinar
Navigating FDA Inspections Successfully: Most Common Observations and Prevention Strategies
In the tightly regulated landscape of FDA-controlled industries, successful navigation through inspections is a cornerstone of organizational success. The Most Common FDA Observations and Prevention Strategies' training addresses the critical need for professi ...
- Intermediate & Advan
- 90 Mins
- Meredith Crabtr
Recorded Webinar
Change Control and Regulatory Impact Assessment
In regulated industries, managing changes to processes, equipment, or materials is critical to ensuring compliance and maintaining product quality. Effective change control systems not only help organizations avoid compliance issues but also streamline operati ...
- Intermediate & Advan
- 90 Mins
- Meredith Crabtr
Recorded Webinar
Data Governance for Computer Systems Regulated by FDA
In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDL ...
- Basic & Intermediate
- 60 Mins
- Carolyn Troiano