Danielle Reynolds

Danielle Reynolds is Managing Director and Founder of D.T. Reynolds Consulting LLC. The company offers a broad range of consulting services to the Pharmaceutical, Chemical, Biotechnology, Life Science support industry and Life Science Workforce Development. With more that 20 years’ experience in the Biologics operations and higher education, Danielle has a proven track record of… Continue reading Danielle Reynolds

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GMP in a Nutshell

The quality of pharmaceutical products is subject to a lot of scrutiny and meticulousness regarding quality because anything less than the best possible quality could result in financial losses and regulatory issues for companies. Good Manufacturing Practices (GMPs) is a set of guidelines used to ensure consistency in the manufacture of quality healthcare products. These… Continue reading GMP in a Nutshell

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Sabrina Ippolito

Sabrina Ippolito, is an accomplished expert in quality systems with over 15 years of experience in the industry. She holds a Bachelor’s degree in Biochemistry and is currently working towards completing her Master’s degree of Education in Adult Education, in addition, she is a member of the professional order of Chemists of Quebec (OCQ). Throughout… Continue reading Sabrina Ippolito

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A Step-by-Step Guide to Implementing QMS

A Quality Management System (QMS) guarantees that products or services consistently fulfill or surpass customer expectations. Emphasizing quality enables organizations to boost customer satisfaction and loyalty, resulting in repeat business and positive feedback. In this fully accredited course, we’ll discuss how implementing a QMS involves several fundamental steps to ensure its effectiveness and success. Each… Continue reading A Step-by-Step Guide to Implementing QMS

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Equipment Qualification in the GxP Environment

Whether your operation is covered by GMP, GLP, or GCP, there is a regulatory requirement to ensure that all equipment used has been properly demonstrated and documented to be functioning properly. Commonly referred to as Installation Qualification, Operational Qualification, and Performance Qualification, IQ/OQ/PQ provides the framework under which this process can be appropriately performed. Overlooking… Continue reading Equipment Qualification in the GxP Environment

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Supervising a Human Error Free Environment 

Supervision plays a crucial role in Human Error Reduction and Control. In this fully accredited training, critical factors like preparation, planning, scheduling, communication, among many others, will be discussed. People make mistakes because they can; our systems allow it. To work with these challenges, it is essential to understand human behavior and the psychology of… Continue reading Supervising a Human Error Free Environment 

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GMP Change Control Process

Change control is a requirement of all regulatory agencies and authorities worldwide. It is a critical GMP function that must be addressed daily. The value of identifying and tracking change is to prevent unintended consequences, remain in proper process alignment, and avoid any alteration of the products’ Safety, Identity, Strength, Purity, and Quality (SISPQ). Many… Continue reading GMP Change Control Process

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Precision Tools for Human Error Reduction

Human error is known to be the primary cause of quality and production losses in many industries. Although human error is unlikely to ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment, many variables that affect human behavior CAN be managed,… Continue reading Precision Tools for Human Error Reduction

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Introduction to Validation Principles, Practices and Requirements

FDA-regulated industries utilize several types of validation to help ensure the quality of their products and to comply with FDA and international regulations and requirements. This training course provides an overview and introduction to Validation principles and requirements. Process validation, Computer System Validation, Cleaning Validation, Methods Validation, Qualifications, and Validations Project Management are all topics discussed in… Continue reading Introduction to Validation Principles, Practices and Requirements

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Introduction to CAPA Management

There have been several form 483s and warning letters being issued to companies by the FDA as it relates to CAPA investigation because of insufficient or incomplete quality systems procedures applicable to Corrective Action and Preventative Action programs(CAPA). Addressing an FDA form 483 with findings associated with CAPA systems must be performed adequately, and completely… Continue reading Introduction to CAPA Management

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