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 Good Documentation Practices (GDP) and Data Integrity
An overview of Good Documentation Practices, including the differences between documents and... more
Career Development: Computer Literacy
This workshop will review computer functionality from a new user’s perspective. It is for anyone... more
Disinfection, Sterilization, and Containment
This course introduces principles of contamination and containment for the biopharmaceutical... more
Advanced Biomanufacturing Training Program
This hybrid course offers 2 separate certifications. Students who complete all sections of this... more
Social Media & Your Career
This virtual course focuses on social media etiquette and professionalism. Participants will learn... more
Cleanroom Gowning
Aseptic gowning is a system of donning apparel to prevent the contamination of aseptic processing... more
GMP and SOP Online
This 24-hour online course covers six modules related to Good Manufacturing Practices (GMP) and... more
Project Execution Planning (PEP) for Qualification
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
Current Good Manufacturing Practices (CGMP)
eLearning
Current Good Manufacturing Practices, or CGMPs, help ensure the quality, safety, and efficacy of a... more
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