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

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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

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Surfactants: Chemistry, Theory,and Application

The high surface tension of water presents challenges to a formulator who attempts to develop products that will properly wet surfaces, disperse pigments, emulsify key components, or even generate or destabilize foam. This accredited course on surfactants (chemistry, theory, mechanism, and application) initially reviews the various types and chemical structures of commercially available surfactants. An… Continue reading Surfactants: Chemistry, Theory,and Application

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Rheology: Chemistry, Theory, and Application

We must understand how materials are affected, by their flow behavior, as a result of applied stress forces. This knowledge will allow a formulator to develop products with the best possible outcome considering production, storage, packaging, and application. This intensive, accredited training course on rheology (chemistry, theory, mechanism, and application) reviews the basic principles of… Continue reading Rheology: Chemistry, Theory, and Application

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Moussa Boukerche

Moussa Boukerche is a highly experienced crystallization scientist with a Ph. D in Chemical Engineering (France). He has over 25 years of expertise in industrial crystallization process development and solid form control. He has worked for renowned companies like Eli Lilly (USA), Abbvie (USA), Pfizer (UK), Aughinish Alumina (Ireland), and SANOFI (France). After leaving AbbVie… Continue reading Moussa Boukerche

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Crystallization: Mastering Seeded Cooling

Crystallization plays a pivotal role in the production of high-quality specialty bulk products. This process will influence particle size, purity, and product yield all while needing to be monitored and controlled to meet a product’s specifications. This accredited training course will provide participants with a comprehensive understanding of the vital role of crystallization, focusing on… Continue reading Crystallization: Mastering Seeded Cooling

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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

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Effective Supplier Audits for the Pharmaceutical and Medical Device Industries

Each party engaged in the manufacture of a medical device, drug, and/or combination product is responsible for ensuring compliance with cGMP for the manufacturing activities it performs. cGMPs include the implementation of oversight and managing the risk and control of suppliers. Auditing is a critical aspect of implementing that oversight. This intensive accredited training will outline the… Continue reading Effective Supplier Audits for the Pharmaceutical and Medical Device Industries

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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

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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.

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