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.
Setting up and Implementing Supplier Audits
Every pharmaceutical, medical device or related industry company must rely on the dependability of their suppliers to consistently provide quality materials and services. Key to this is the establishment up front of a supplier quality agreement. But even once created and agreed upon, periodic audits are necessary to ensure it is being routinely followed. The… Continue reading Setting up and Implementing Supplier Audits
Read MoreManaging FDA Inspections: The FDA Investigator Cometh…Are You Ready?
In its role mandated by the FD&C Act, FDA periodically performs site inspections to ensure that Pharmaceutical and Medical Device companies are in compliance with current Good Manufacturing Practices (cGMPs). The goal of these inspections is to ensure that establishments consistently manufacture drug products of acceptable quality and minimize consumers’ exposure to adulterated drug products.… Continue reading Managing FDA Inspections: The FDA Investigator Cometh…Are You Ready?
Read MoreAvoiding Pharmaceutical and BioPharmaceutical Data Integrity Problems
With a focus on the FDA Draft Guidance In recent years, states the Agency, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections.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… Continue reading Avoiding Pharmaceutical and BioPharmaceutical Data Integrity Problems
Read MorePackaging Process Validations: Pharmaceutical and 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 and Medical Devices
Read MoreIQ, OQ, PQ
Executing Installation, Operational and Performance Qualifications in Support of Process Validations The Installation/Operational/Performance Qualification 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… Continue reading IQ, OQ, PQ
Read MoreCMC Writing and Submission Strategies: A Global Regulatory Approach
The ICH Common Technical Document (CTD) is the basis of drug and biologic registration applications, and a proper understanding of CTD writing strategy and health authority expectations can greatly aid a company in gaining approval. This 12- hour accredited training ON DEMAND (with included prerequisite online course), will provide in-depth instruction on Chemistry, Manufacturing and… Continue reading CMC Writing and Submission Strategies: A Global Regulatory Approach
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
Read MoreCurrent Good Tissue Practices (cGTP): Establishing and Maintaining FDA Compliance
“All organizations that recover, screen, test, process, store, label, pack and/or distribute Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) must adhere to the current Good Tissue Practice regulation (cGTP), 21 CFR Part 1271 Subparts D. Set by US FDA, this regulation can appear to be a confusing collection of legal requirements for the… Continue reading Current Good Tissue Practices (cGTP): Establishing and Maintaining FDA Compliance
Read MoreConducting a Robust Root Cause Investigation for CAPA
One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA uses investigation reports and investigation trends to identify potential quality problems in all areas of the company. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, release of a sub-standard product, or product recall. Furthermore, costly… Continue reading Conducting a Robust Root Cause Investigation for CAPA
Read MoreGLP Study Director: How to Deal with GLP, Sponsors, QA and Multi-Site Challenges
Benjamin Franklin famously said: Tell me and I forget, teach me and I may remember, involve me and I learn This intensive 8- hour accredited course has been entirely redesigned with Franklin’s cogent observation in mind so that each person can get involved in problem-solving and thus learn about how to run regulatory studies that… Continue reading GLP Study Director: How to Deal with GLP, Sponsors, QA and Multi-Site Challenges
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