Spray Drying: Operation, Optimization and Design Aspects
This accredited online training focuses on the Spray-Drying process and technology, which is present in numerous industries. Even though the training will focus on the fundamentals of spray drying by emphasizing scientific principles that are common to any industry, specific examples will be given for applications in Food, Beverages, Chemicals, Pharmaceuticals, Pulp and Paper, etc.… Continue reading Spray Drying: Operation, Optimization and Design Aspects
Read MoreAvoiding Pharmaceutical and BioPharmaceutical Data Integrity Problems
“In recent years,” states the Agency, “FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections.” While a few of these situations may actually involve intentional fraud, others may occur where simply inadequate controls have been put into place to prevent data manipulation. Whether intentional or not, FDA views these situations as unacceptable.… Continue reading Avoiding Pharmaceutical and BioPharmaceutical Data Integrity Problems
Read MorePolymers in the Personal Care Industry
The unique chemical properties of polymers can be customized to meet various product needs, making them a valuable addition to personal care products. However, with numerous polymers available, it’s crucial to determine which ones are suitable for achieving specific product characteristics. This 90-minute accredited online training course delves into the diverse classification of polymer chemistry.… Continue reading Polymers in the Personal Care Industry
Read MoreGLP and Quality Assurance
Benjamin Franklin famously said: “Tell me and I forget; teach me and I may remember; involve me and I learn.” This course has been designed with this cogent observation in mind so that each person can get involved in problem-solving and thus learn about how to perform the role of Quality Assurance for laboratories undertaking… Continue reading GLP and Quality Assurance
Read MoreBasic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program
cGMP drug products rely on the bacterial endotoxin test as a critical release test for products based on the route of administration of the drug product. Having a good concept of this critical release assay, its application and importance to the manufacture of cGMP product is valuable to avoid costly errors, batch disposal, expensive failure… Continue reading Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program
Read MoreThe QbD Toolbox
If you are charged with exploring or implementing a QbD effort within your organization, where do you begin? Available guidance documents do not provide all of the information necessary to effectively implement such a program. Without proper understanding of how to establish QbD, your efforts may fail. This accredited training course presents methods that assist… Continue reading The QbD Toolbox
Read MorePackaging Process Validations: Pharmaceutical & Medical Devices
The integrity of a package depends on the qualification of the packaging equipment, the packaging process, and consistent performance throughout the commercial packaging run. No matter how well the container/closure has been developed, it cannot protect the product as designed if it is not properly sealed and packed. The packaging process validation ensures that packages… Continue reading Packaging Process Validations: Pharmaceutical & Medical Devices
Read MoreIQ/OQ/PQ
The Installation/Operational/Performance Qualification (IQ/OQ/PQ) of equipment, systems and facilities for sterile, oral solid dosage forms, liquids, finished and bulk drugs in the Pharmaceutical and Bio Pharmaceutical manufacturing operations are essential parts of the overall validation process. Equipment and systems must be installed, operated, and maintained within design specifications and facilities must be accepted as fit… Continue reading IQ/OQ/PQ
Read MoreCMC Writing and Submission Strategies
The CTD is the basis of drug, biologic, and drug-device combination registration applications. A proper understanding of CTD writing strategy and health authority expectations can greatly aid a company in gaining approval. With the prerequisite complete, this accredited training, will provide in-depth instruction on Chemistry, Manufacturing, and Controls (CMC) requirements and review processes for clinical… Continue reading CMC Writing and Submission Strategies
Read MoreAnnual Product Reviews/Product Quality Reviews
Periodic Product Quality Reviews or Annual Product Reviews of drug products are required by the U.S., EU, and Canada. The purpose of the annual product quality review course is to educate the participant in the regulatory requirements for the FDA Annual Product Review while demonstrating the power of the Periodic or Annual Product Review as… Continue reading Annual Product Reviews/Product Quality Reviews
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