Subject: QA/QC

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

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

Detergents and Cleaning Products

Like other industries, the cleaning products industry has had to adapt to the changes forced on it by the COVID-19 pandemic. The sector has a unique role in ensuring society remains clean, healthy, and free from infections. Thus, our industry has suffered less than most. We will review how the industry has developed to its… Continue reading Detergents and Cleaning Products

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

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

Laura Jeannel

Laura Jeannel is a Senior Quality Consultant for Farbridge Pharma Consulting, is an experienced Quality Assurance professional, leading as a former Quality Director and key consultant for over 20 years. During her career, she has led major pharmaceutical companies in establishing, executing, and continuous improvement for sustainable Quality Management Systems. Ms. Jeannel has been responsible… Continue reading Laura Jeannel

Sunscreen Basics

In the Cosmetic and Personal care market, almost everyday creams claim to offer a sun protection factor or SPF, and body products for summer holidays claim high SPF numbers. In the U.S. the sun-filters (UV absorbing molecules) are listed on a positive list, they are considered drugs that can be sold over the counter (OTC),… Continue reading Sunscreen Basics

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

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

Management of Pharmaceutical Water in a GMP Environment

Knowledge of the microbiology of water in a GMP environment is critical to the health of any water system being used to produce a pharmaceutical or biotechnology product. Even companies manufacturing tablets need to be aware of the quality of the water that may be contacting their process or product. The well-being of a facility… Continue reading Management of Pharmaceutical Water in a GMP Environment