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Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software
As part of the Case for Quality program US FDA CDRH (Center for Devices and Radiological Health) have identified that an excessive focus on compliance rather than quality may divert resources and management attention towards meeting regulatory compliance requi ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
- Mar 02, 2021
Controlling Human Error in the Manufacturing Floor
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. ...
- Basic & Intermediate
- 90 Mins
- Ginette Collazo
- Mar 09, 2021
Best Practices for Preparing for an FDA Computer System Validation Audit
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer syst ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
- Apr 06, 2021
The 6 Most Common Problems in FDA Software Validation and Verification
This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
- Basic & Intermediate
- 120 Mins
- David Nettleton
- Apr 07, 2021
Proper CAPA Management
In order to solve problems, every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can a ...
- Intermediate
- 60 Mins
- Danielle Delucy
Establishing A Robust Supplier Management Program
Regulatory expectations are clear about manufactures’ responsibility regarding supplier quality oversight.All regulatory agencies agree that pharmaceutical and medical device manufactures are responsible for ensuring their suppliers adhere to quality standards ...
- Basic & Intermediate
- 90 Mins
- Kelly Thomas
Human Error Reduction Techniques for Floor Supervisors
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
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration
All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21 CFR ...
- Basic & Intermediate
- 60 Mins
- José Mora
Validation Essentials for Medical Device Manufacturers - IQ, OQ, PQ
This course will cover validation essentials for medical device manufacturers. Attendees will learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol ...
- Basic & Intermediate
- 90 Mins
- Susanne Manz
21 CFR Part 11 (Electronic Records and Signatures) Compliance for Computer Systems Regulated by FDA
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, ...
- Intermediate
- 90 Mins
- Carolyn Troiano