Subject: GMP

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 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

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

INCI: International Nomenclature of Cosmetic Ingredients

In 1973 The Cosmetic, Toiletry, Fragrance Association (CTFA) developed an industry voluntary process for assigning ingredient names that provides the consumer and medical field a common approach to understanding what is formulated in a personal care product. This process was accepted by the United States Food & Drug Administration (FDA) and the global regulatory community,… Continue reading INCI: International Nomenclature of Cosmetic Ingredients