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The 6 Most Common Problems in FDA Software Validation and Verification
This training on FDA software validation and verification will provide you with the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
- Basic & Intermediate
- 120 Mins
- David Nettleton
- Aug 12, 2022
Practical Technical Writing Techniques
Technical Writing generally conforms to Good Documentation Practices (GDocP). This term describes standards to create and maintain documents. Also addressed in the webinar are principles to create Technical Documents. Most companies have in-house requirements ...
- Basic & Intermediate
- 60 Mins
- Robert Peoples
- Aug 15, 2022
How to Write Sop’s for Human Error Reduction
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. Proced ...
- Basic & Advanced
- 90 Mins
- Ginette Collazo
- Aug 18, 2022
How to deal with bad results under GLP
Assessment of the cause for non-compliance is a structured series of branching questions. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts a ...
- Basic & Intermediate
- 60 Mins
- John Fetzer
- Aug 22, 2022
Medical Device Cyber security and FDA Compliance
This webinar will focus on the cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device coul ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
- Aug 23, 2022
Project Management for Non-Project Managers - Scheduling your Project
This webinar is about scheduling and how to structure a project schedule that works and ensures the accomplishment of the project’s objectives. Participants will be walked through the scheduling process from start to finish in language that will clearly descr ...
- Basic & Intermediate
- 90 Mins
- Charles H. Paul
- Aug 25, 2022
Pharmaceutical Compressed Air:Quality GMP Standards and Requirements
Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction, and monitoring of a compressed air system are essential for maintaining a quali ...
- Intermediate
- 60 Mins
- Roger Cowan
- Aug 30, 2022
Policies, Process, and Procedures
The objective of the webinar is to present suggestions and hints to create Policies, Processes, and Procedures that can be applied to various fields and/or departments of organizations. Many fields can benefit from learning how to create Policies, Processes, ...
- Basic & Intermediate
- 60 Mins
- Robert Peoples
- Aug 31, 2022
DHF, DMR, DHR, and EU Technical Documentation
This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF -- including its derivitive documents, the DMR and DHR.It will consider the European Union's MDD TF/DD requirements currently being phased out and the new EU MDR Technical ...
- Intermediate
- 90 Mins
- John E. Lincoln
- Sep 06, 2022
Best Practices for Preparing for an FDA Computer System 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 sys ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Sep 07, 2022