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.

GMP and SOP Online
This 24-hour online course covers six modules related to Good Manufacturing Practices (GMP) and... more
This course provides a broad overview of the United States Food and Drug Administration (FDA)... more
Good Lab Practices: FDA and EPA Regulations
Understand the documentation guidelines required to generate acceptable EPA and FDA product... more
Elements of Current Good Manufacturing Practices (cGMP) in Biomanufacturing Processes
Understand the fundamentals of current Good Manufacturing Practices (CGMP) for Biomanufacturing.... 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
Bio-Agricultural Program Readiness Opportunity
The Bio-Agricultural Program Readiness Opportunity (BioAg PRO) provides practical, hands-on... more
FDA Audit Preparation
FDA Audit Preparation is designed to help create an environment of preparedness to instill a... more
FDA Audit Preparation
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.

Learn Now
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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