The research, development, manufacturing, and regulatory approval of new biotechnology and biopharmaceutical products often presents novel challenges for which a background in conventional pharmaceuticals offers little guidance.
To bridge this gap between academic instruction and the real-world complexities of research, development, validation, regulations, processing, and manufacturing, we provide practical, specialized training by industry experts. With ever-changing scientific understanding and government regulations, it’s critical that you have the most current information possible – training with COBBLESTONE ensures you will.
Sterilization Professionals Certification
In the FDA’s Guide to Sterilization Process Controls, the FDA stated five (5) key inspectional objectives which are used by the agency during routine inspections of sterilization and sterility assurance processes. One of the key areas of concern pertains to the production and process control subsystem (including sterilization process controls) which requires that manufacturers of… Continue reading Sterilization Professionals Certification
Read MoreGMP Professional Certification
The GMP Professional Certification Program will provide the necessary orientation and understanding of the USA FDA’s Current Good Manufacturing Practice for pharmaceutical products. The certification program will cover techniques and practices to ensure compliance with these regulations including manufacturing, packaging, holding, distribution and the laboratory. It will provide a practical application of the cGMP on… Continue reading GMP Professional Certification
Read MoreFDA Inspection Readiness Certification
The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading FDA Inspection Readiness Certification
Read MorePackaging 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
Read MoreWriting 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
Read MoreQuality Management and Compliance in the Pharmaceutical and Related Industries
Under the global regulator-based inspection approach, the Quality system is one that is routinely audited. Quality issues are a huge factor in inspection observations leading to recalls for drugs, biologics, and medical devices. This indicates that not all companies are meeting current GMP expectations. Clearly a better understanding is needed to overcome this trend and… Continue reading Quality Management and Compliance in the Pharmaceutical and Related Industries
Read MoreLyophilization 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
Read MoreSterile 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
Read MoreGood Laboratory Practices (GLP)
Benjamin Franklin famously said: Tell me and I forget, teach me and I may remember, involve me and I learn. This course has been entirely redesigned with this cogent observation in mind so that each person can get involved in problem-solving and thus learn about Good Laboratory Practice (GLP) Regulations. Overall, the main intent of… Continue reading Good Laboratory Practices (GLP)
Read MoreDrug Product Stability and Shelf-Life
“An Intensive Review of Technical and Regulatory Aspects No drug product enters the marketplace without adequate stability data first. While ICH has harmonized and standardized the approach to performing stability, a number of challenges are still routinely faced while conducting stability testing. Since inadequate stability can lead to product introduction delays, all drug companies need… Continue reading Drug Product Stability and Shelf-Life
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