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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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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Introduction to Batch Record Review

Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process to demonstrate compliance. A strong batch record review system is essential to properly document all critical and operational process parameters that go… Continue reading Introduction to Batch Record Review

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Ethylene Oxide: Product Adoption and Parametric Release

Ethylene Oxide (ETO) Sterilization is a critical process for medical devices, which might include pharmaceuticals and the food industry. Today, the challenge is to understand product adoption during material changes to simplify and have a more robust product validation process based on product families. Another benefit is to have a better understanding on Parametric Release… Continue reading Ethylene Oxide: Product Adoption and Parametric Release

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cGMPs for Biologics

This intensive 8-hour accredited training will provide an oversight into cGMPs for Biologics, and large molecule manufacturing from development to engineering batches to Process Performance Qualification (PPQ) lots including analytical method validation. A review of vital and current Biopharmaceutical/Biologics processes will be reviewed for current Quality/Regulatory expectations. Key insights are presented for both FDA and… Continue reading cGMPs for Biologics

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Ricardo Franco

Ricardo Franco, a Senior Quality Professional with experience in the chemical, medical, and pharmaceutical industries, is an experienced quality assurance professional who has led as a former Senior Quality Manager for diverse companies for over 35 years, such as EASTMAN Kodak, EASTMAN Chemical Corp., STERIS Applied Sterilization Technologies, and Integra Life Sciences. He is currently… Continue reading Ricardo Franco

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Microbiology 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 products, 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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An Introduction to Current Good Tissue Practice (GTP)

The US FDA’s current Good Tissue Practice regulations constitute a significant compliance challenge for the Human Tissue Industry. This course is intended to provide hands-on training for anyone who works for human cell, tissue, and cellular and tissue-based products companies which must comply with CGTP. In this intensive training, we will review the Public Health… Continue reading An Introduction to Current Good Tissue Practice (GTP)

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We’ve rebranded! CfPA is now COBBLESTONE