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.

Elements of Supplier and Internal Quality Audits
Regulatory authorities are increasingly expecting on-going, competent assessments of internally and... more
CGMP Overview for Medical Devices
This course provides an overview of the Food and Drug Administration (FDA) principles, requirements... more
Cleanroom Gowning
Aseptic gowning is a system of donning apparel to prevent the contamination of aseptic processing... more
Aseptic Processing: Concepts
Aseptic processing is utilized to prevent contamination and manufacture sterile products to ensure... 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
GMP and SOP Online
This 24-hour online course covers six modules related to Good Manufacturing Practices (GMP) and... more
This course allows participants to experience biopharmaceutical manufacturing through lectures and... more
Advanced Biomanufacturing Training Program
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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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
eLearning
See how clinical trials of a research drug or medical device are conducted and managed.
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