The research, development, manufacturing, and regulatory approval of new biotechnology and biopharmaceutical products often presents novel challenges for which a background in conventional pharmaceuticals offers little guidance.
To bridge this gap between academic instruction and the real-world complexities of research, development, validation, regulations, processing, and manufacturing, we provide practical, specialized training by industry experts. With ever-changing scientific understanding and government regulations, it’s critical that you have the most current information possible – training with COBBLESTONE ensures you will.
21 CFR 211 Subparts I: Laboratory Controls
This course has been developed to meet the training needs of professionals in the Pharmaceutical, Medical Device and Cosmetic Industries. It will be especially valuable to those engaged in compliance with FDA regulations, Compliance, QA/QC, Formulation, Production, Manufacturing and Regulatory areas. Engineers, chemists, QA/QC and manufacturing personnel will benefit greatly by attending this course by… Continue reading 21 CFR 211 Subparts I: Laboratory Controls
Read More21 CFR 211 Subparts J & K: Records and Salvaged Drug Product
This course has been developed to meet the training needs of professionals in the Pharmaceutical, Medical Device and Cosmetic Industries. It will be especially valuable to those engaged in compliance with FDA regulations, Compliance, QA/QC, Formulation, Production, Manufacturing and Regulatory areas. Engineers, chemists, QA/QC and manufacturing personnel will benefit greatly by attending this course by… Continue reading 21 CFR 211 Subparts J & K: Records and Salvaged Drug Product
Read MoreFDA Quality Systems Guideline
This course has been developed to meet the training needs of professionals in the Pharmaceutical, Medical Device and Cosmetic Industries. It will be especially valuable to those engaged in compliance with FDA regulations, Compliance, QA/QC, Formulation, Production, Manufacturing and Regulatory areas. Engineers, chemists, QA/QC and manufacturing personnel will benefit greatly by attending this course by… Continue reading FDA Quality Systems Guideline
Read MorecGMP Compliance and non-Compliance
This course has been developed to meet the training needs of professionals in the Pharmaceutical, Medical Device and Cosmetic Industries. It will be especially valuable to those engaged in compliance with FDA regulations, Compliance, QA/QC, Formulation, Production, Manufacturing and Regulatory areas. Engineers, chemists, QA/QC and manufacturing personnel will benefit greatly by attending this course by… Continue reading cGMP Compliance and non-Compliance
Read MorecGMP Compliance: and Process Validation
This course has been developed to meet the training needs of professionals in the Pharmaceutical, Medical Device and Cosmetic Industries. It will be especially valuable to those engaged in compliance with FDA regulations, Compliance, QA/QC, Formulation, Production, Manufacturing and Regulatory areas. Engineers, chemists, QA/QC and manufacturing personnel will benefit greatly by attending this course by… Continue reading cGMP Compliance: and Process Validation
Read MoreManagement of Pharmaceutical Water in a GMP Environment
This 90-minute course is intended for all scientists and technologists interested in developing a basic understanding or refresher of the basics of microbiology and the ramifications of non-compliance. The material will be presented in such a way as to be a value to a varying level of expertise. This course will especially benefit those in:… Continue reading Management of Pharmaceutical Water in a GMP Environment
Read MoreAn Introduction to Current Good Tissue Practice (GTP)
This course is intended for anyone who works for registered human cell, tissue, and cellular and tissue-based product (HCT/Ps) establishments which must comply with CGTP regulations. It is especially valuable to: – Executive Directors and CEOs – Recovery Personnel – Compliance Professionals – MDs and Medical Directors – Quality Assurance Managers and Personnel – Legal… Continue reading An Introduction to Current Good Tissue Practice (GTP)
Read MorePharmacopoeia Compliance: An Overview [FREE WEBINAR]
How to Meet Legal, Regulatory, and Compendial Requirements Compliance with requirements published by pharmacopoeias around the world is a legal and regulatory requirement in those countries and regions in which the pharmacopeia is applicable. This fundamental, and often misunderstood – principle is an important consideration throughout the drug product life cycle across the bio/pharmaceutical industry.… Continue reading Pharmacopoeia Compliance: An Overview [FREE WEBINAR]
Read MoreIntroduction to Tablet Manufacturing by the Direct Compression Process
Solid oral dosage forms such as tablets and capsules represent the most common type of pharmaceutical products produced. In the patient’s hand, a tablet can seem like a simple product not knowing there are numerous complexities that go into its manufacture. But for the manufacturer, without a clear understanding of the science behind the ingredients… Continue reading Introduction to Tablet Manufacturing by the Direct Compression Process
Read MoreMicrobiology for the Non-Microbiologist
Appropriate as a GMP Microbiological Refresher With the increasing number of Regulatory Actions throughout North America to include Form FDA 483s and Warning Letters for both Active Pharmaceutical Ingredients (APIs) and finished product, it has become increasingly important for companies and individuals manufacturing both non-sterile and sterile final products, to have a basic understanding of… Continue reading Microbiology for the Non-Microbiologist
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