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.
Scope of the FDA – History and FDA Regulations
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 Scope of the FDA – History and FDA Regulations
Read More21 CFR 211 Subparts A & B: Quality and Personnel
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 A & B: Quality and Personnel
Read More21 CFR 211 Subparts C & D: Facility and Equipment
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 C & D: Facility and Equipment
Read More21 CFR 211 Subparts E & F: Control of Components and Production/Process Control
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 E & F: Control of Components and Production/Process Control
Read More21 CFR 211 Subparts G & H: Packaging, Labeling and Distribution
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 G & H: Packaging, Labeling and Distribution
Read MoreFDA Case Scenarios: Best Practices for Managing Inspection Situations
The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading FDA Case Scenarios: Best Practices for Managing Inspection Situations
Read MoreConducting Successful Quality Audits: Best Practices for Managing Inspection Situations
The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading Conducting Successful Quality Audits: Best Practices for Managing Inspection Situations
Read MoreCapturing Justifications in Change Control, Risk Assessment, Validations, and Investigations
The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations
Read MoreManaging Effective Regulatory Inspections and 483 Responses
The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading Managing Effective Regulatory Inspections and 483 Responses
Read MoreComputer System Validation: A Regulatory Overview
The ever-increasing use of computers within the life science industries draws the attention of the FDA and international regulatory agencies. In recent years we have moved from simple record-keeping systems to computer-controlled processing, manufacturing, devices, and inventory systems. As we look forward to the increasing use of artificial intelligence, we will require increasingly sophisticated computers,… Continue reading Computer System Validation: A Regulatory Overview
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