Quality Systems

Quality management can be a challenge for regulated companies.

Quality Systems

Our Quality Systems training curriculum offers a variety of courses designed to help manufacturers in the Life Sciences industry ensure that the manufacture of products adheres to current good manufacturing practices, assuring the safety and efficacy of such products. Some of our course offerings include the following topics: CAPA, audits (internal, supplier, FDA), CGMPs, Writing Effective SOPs, and Report Writing. These can either be offered onsite or at your facility. Through our training, experienced, enthusiastic, quality professionals are eager to assist you in understanding your requirements better and building a robust quality management business approach that would turn any challenges into opportunities for product improvement and continued success.

FDA Audit Preparation
FDA Audit Preparation is designed to help create an environment of preparedness to instill a... more
This course provides a broad overview of the United States Food and Drug Administration (FDA)... more
Elements of Current Good Manufacturing Practices (cGMP) in Biomanufacturing Processes
Understand the fundamentals of current Good Manufacturing Practices (CGMP) for Biomanufacturing.... more
Project Execution Planning (PEP) for Qualification
A Project Execution Plan (PEP) is much more than a chart showing timescales - it is a document... more
Elements of Current Good Manufacturing Practices (cGMP) in Biomanufacturing Processes
Rosa Fernandez

Rosa Fernandez, Industry Trainer
rfernandez@ncbionetwork.org
919-513-2785

Rosa manages BioNetwork’s Validation Academy and teaches validation and quality systems courses. She has over 20 years of product life cycle management experience in the pharma and medical device industries including R&D, manufacturing, QC, QA, and regulatory affairs.

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cGMP Basics
eLearning
Lesson 1: Introduction to Current Good Manufacturing Practices, introduces the fundamentals of cGMP... more
cGMP Bloodborne Pathogens
eLearning
Lesson 2: Bloodborne Pathogeons explores the fundamentals, transmission methods, and prevention... more
cGMP OSHA
eLearning
Lesson 3: In this guided exercise, learners will explore environmental protection policies, look at... more
Clinical Research Study Management
eLearning
Clinical research trials can be very complex and time consuming. This eLearning module will... more
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