Subject: QA/QC

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 

Dennis Smith

Dennis Smith is currently the President of the Eastern Aerosol Association. Dennis has over 40 years of experience in the industry, working for component suppliers and fillers. He has worked on aerosol projects in the capacity of Lab Technician, Technical Sales, Director of Package Development, Owner of Dennis Smith Consulting, and VP of Sales at… Continue reading Dennis Smith

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

Agi Denes, PhD

Dr. Agi Denes is a highly experienced cosmetic chemist and scientist with over 20 years in the field where she brought to life novel personal care product lines that are at the intersection of science, beauty, and wellness. She has an exceptional interdisciplinary technical expertise across formulations, innovation, technical marketing, claims design and validation, testing… Continue reading Agi Denes, PhD

Precision Tools for 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 Error Reduction

James (Jamey) K. Jarman

James K. (Jamey) Jarman is a Manger of Technical Services for Baxter BioPharma Solutions in Bloomington, Indiana. He has over 25 years of pharmaceutical manufacturing experience, specifically in sterile parenteral manufacturing. Mr. Jarman’s background includes aseptic filling operations for vial, syringe, and cartridge products; suspension filling, lyophilized product manufacturing, formulation activities; equipment, and component preparation,… Continue reading James (Jamey) K. Jarman

Beverly Barnwell

Beverly Barnwell is an independent consultant with over thirty-five years of experience, thirty-one of these years with the Johnson & Johnson family of companies. Bev began her career at McNeil Consumer Healthcare in the product stability group, supporting both Developmental and Marketed Products for the McNeil portfolio. As she transitioned to the pharmaceutical sector (Janssen Pharmaceuticals),… Continue reading Beverly Barnwell

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

Starches: Fundamentals and Process Applications in Industrial Operations

This comprehensive training course is on the fundamentals of starch science and its applications in various industries. The course will cover the basics of starch chemistry, structure, and properties, and how these properties can be tailored to suit different industrial applications. Participants can expect to learn about the different types of starches and their functional… Continue reading Starches: Fundamentals and Process Applications in Industrial Operations

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