Subject: GMP

GMP in a Nutshell: Introduction to Current Good Manufacturing Practices

The quality of pharmaceutical products is subject to rigorous scrutiny and meticulous control because anything less than the best possible quality could result in regulatory issues. More importantly, compromised quality could jeopardize patient safety, leading to potentially serious health risks. Current Good Manufacturing Practices (cGMPs) are regulations (21CFR210-211) used to ensure consistency in the manufacture… Continue reading GMP in a Nutshell: Introduction to Current Good Manufacturing Practices

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 

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

Optimization of Powders for Flowability

There are several metrics that formulators use to quantify the flowability of powder blends, including angle of repose, Carr and Hausner ratios, FFC, and flow energies. They all have one thing in common: none will predict whether or not a powder will flow in a hopper. Frequently, powders that are deemed easy flowing exhibit flow… Continue reading Optimization of Powders for Flowability

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

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

Good Manufacturing Practices (GMP) for Foods

This course is designed to provide participants with comprehensive knowledge and practical skills in developing an effective Food Safety Program. The course covers the essential elements of food safety, including good manufacturing practices, and Hazard Analysis and Critical Control Points (HACCP) programs, specifically tailored for food manufacturing facilities, and sanitary design. The course will explore the fundamental… Continue reading Good Manufacturing Practices (GMP) for Foods

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

cGMPs for Biologics

This intensive 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 EU… Continue reading cGMPs for Biologics

21 CFR 211 Subparts A & B: Quality and Personnel

Most industries in the US are regulated by local, state, and federal regulators, and pharmaceutical manufacturing companies are some of the most highly regulated, particularly at the federal level. Pharmaceutical Quality affects every American; hence the FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standards for ensuring pharmaceutical quality are the Current… Continue reading 21 CFR 211 Subparts A & B: Quality and Personnel