Industry: Pharmaceutical Science & Technology

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

Walter G. Chambliss, Ph.D.

Walter G. Chambliss, Ph.D., is Professor Emeritus of Pharmaceutics and Drug Delivery and Research Professor Emeritus at the Research Institute of Pharmaceutical Sciences at the University of Mississippi. He teaches graduate courses in pharmaceutical formulation development, manufacturing, and regulatory sciences. He also lectures in the Hands-on Course in Tablet Technology (tabcourse.com), a post-graduate education course.… Continue reading Walter G. Chambliss, Ph.D.

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

Writing Effective Regulatory, Medical and Technical Documents

The success of a company’s drug product or medical device regulatory submission is heavily dependent on the quality of its documentation submitted to regulatory authorities. Therefore, crafting precise, concise, well-referenced, and unambiguous technical documents is vital for business success. To produce such high-quality documents, effective writing skills must be continually honed. In this accredited course, you will… Continue reading Writing Effective Regulatory, Medical and Technical Documents

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

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

Developing and Optimizing of Roll Compacted Granulations for Tablets

Granulating is the most popular way to prepare materials for tableting. Many excipients and actives used in modern direct compression processes are granulated. The granulation process, using only pressure for particle size enlargement, is dry granulation (Roll compaction (RC)). The RC process, even though simple in principle, can be quite complex. Besides proper machine setup,… Continue reading Developing and Optimizing of Roll Compacted Granulations for Tablets