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.

Good Documentation Practices for Medical Devices
This course presents the regulatory requirements and best practices for medical device documents,... more
Disinfection, Sterilization, and Containment
This course introduces principles of contamination and containment for the biopharmaceutical... 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
Report Writing; Considerations and Best Practices
Take command of your report and learn how to write clear, accurate, and easy-to-read professional... more
Biomanufacturing Bootcamp
This course allows participants to experience biopharmaceutical manufacturing through lectures and... more
Elements of Good Documentation Practices (GDP) and Data Integrity
An overview of Good Documentation Practices, including the differences between documents and... more
CGMP Overview for Pharmaceuticals
This overview of CGMP for Pharma outlines the fundamentals of current Good Manufacturing Practices... more
Biomanufacturing Bootcamp
Greg Smith

Greg Smith, Industry Trainer
gsmith@ncbionetwork.org
252-757-3590

Greg has served as a bioprocessing and pharmaceutical industry trainer for over 18 years. He leverages his professional experience in new drug research and development, cGMP facilities, quality control, quality assurance, cleanroom operations, environmental monitoring and microbiology operations. He has designed several labs and cleanroom spaces, and has been instrumental in working with companies to assure contamination control through aseptic practices.

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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Autoclave Operation
eLearning
In this interactive lesson, we'll cover an overview of the autoclave, review safety considerations... more
Batch Documents
eLearning
In this interactive exercise, you will learn the importance of batch documents by reviewing the... more
Bioflow 110 Bioreactor
eLearning
The BioFlow 110 Bioreactor is used to incubate cells on a laboratory scale. In this module, you... more
Bioprocessing Part 3: Purification
Video
This video is the third in a series of three videos depicting the major stages of industrial-scale... more
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