Subject: Manufacturing

Packaging Pharmaceuticals, Medical Devices, and Combination Products

No pharmaceutical, medical device, cosmetic, or personal care product enters the marketplace without a package. This package not only ensures the stability of the product but can also ensure proper dosing or enhance product appearance. With the multitude of packaging options available, it can be a daunting task to select the best package option without… Continue reading Packaging Pharmaceuticals, Medical Devices, and Combination Products

Writing Effective Regulatory, Medical and Technical Documents

The approval of a drug product or medical device regulatory submission hinges in large part on the quality of the documents submitted to regulatory authorities. Thus, writing accurate, concise, well-referenced and clear technical documents is critical for a company’s business success. Effective writing is a skill that must be constantly refined to produce these quality… Continue reading Writing Effective Regulatory, Medical and Technical Documents

Fired Process Heaters

Fired process heaters (also known as fired heaters, process heaters, furnaces, process furnaces, and direct-fired heaters) are critical pieces of equipment in petroleum refineries, petrochemical plants, chemical plants, and other industrial process facilities where providing heat to a process fluid at elevated temperature levels is required. They are a major consumer of energy in such… Continue reading Fired Process Heaters

Lyophilization of Pharmaceutical Drug Products

Lyophilization offers unique properties for delivering critical parenteral drugs. Therefore, developing the formulation and the manufacturing process is challenging. Only through a clear identification of the process and key excipients can a robust formulation be developed and manufactured. This intensive, 8-hour accredited ON DEMAND training including demonstrations conducted by The McCrone Group, Inc. will be… Continue reading Lyophilization of Pharmaceutical Drug Products

Sterile Products: Formulation, Manufacture and Quality Assurance

Parenteral product development and aseptic manufacturing can be intimidating to people new to the topics. The approach to formulation and process development is substantially different than for oral and topical medications. Product development and manufacturing must consider how all of the manufacturing processes align to ensure chemical, physical, and microbiological stability with particular attention to… Continue reading Sterile Products: Formulation, Manufacture and Quality Assurance

Starch Technology

Starch is a recognized natural hydrophilic polymer that is popularly utilized in various kinds of formulations as a swelling agent and gelforming excipient. It has multiple structural arrangements and functionalities. This 12-hour accredited ON DEMAND course will cover the science and operational aspects of products using starches, which are amongst the most important ingredients used… Continue reading Starch Technology

Food Extrusion Technology

“Food extrusion has become a very important processing operation. Today, the food extruder is used to produce pasta and other cold formed products, ready-to-eat cereals, snacks, pet food, aquatic feeds, confectionery products, modified starches for soup, infant food, and instant foods, beverage bases, and texturized vegetable proteins. This 12 hour accredited ON DEMAND training is… Continue reading Food Extrusion Technology

Agi Denes, Ph.D

Dr. Agi Denes is a highly experienced cosmetic chemist and scientist with over 18 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, Ph.D

Joy Joseph

Joy Joseph is President of Joys Quality Management Systems, a consulting firm serving Dietary Supplement firms through training and implementation of the new cGMPs. She has more than 40 years experience in Quality Control Systems, Regulatory Affairs, Product Development, Manufacturing, and Scientific Affairs in the Pharmaceutical, Dietary Supplement and Cosmetic industries. Ms. Joseph received her… Continue reading Joy Joseph

Zeinab Schwen

Zeinab Schwen is an experienced technical expert, writer, lecturer, and entrepreneur with over 39 years in the pharmaceutical and medical device industries. While working for major pharmaceutical companies, Ms. Schwen gained hands-on experience in drug metabolism, drug development, and clinical trial management. She monitored large multicenter trials and participated in writing and preparing large drug… Continue reading Zeinab Schwen