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.
IQ, OQ and PQ for the Laboratory
The FDA’s 21 CFR Part 211.160 establishes the legal requirement for calibrating laboratory equipment. Now more commonly referred to as Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ), the qualification of equipment in a GMP Laboratory in the Pharmaceutical and Bio Pharmaceutical manufacturing operations are essential parts of the overall validation process and ongoing commercial batch release. Data… Continue reading IQ, OQ and PQ for the Laboratory
Read MoreThe Art and Science of Product Claims
Differentiating claims are often key to successful OTC and CPG products. Consumer awareness of products is based on these label and advertising claims that need to be both consumer meaningful and grounded in adequate scientific support. Agencies like the US-FDA, Federal Trade Commission (FTC) and even TV networks have established requirements and guidelines on how… Continue reading The Art and Science of Product Claims
Read MoreCompetitive Intelligence in Product Development
How to Ensure Your Product Has the Edge Over Its Competition Consider any successful product or service and it is highly likely its benefits and differentiation were informed by competitive intelligence. Without it, the product or service may fail and soon disappear from the shelf. Competitive intelligence can literally make that much of a difference.… Continue reading Competitive Intelligence in Product Development
Read MoreCleanroom, Microbiology and Sterility Assurance Practices
This intensive, 12- Hour course provides attendees a comprehensive knowledge about the A-Z of Sterility Assurance which is based on regulatory requirements, FDA guidance, compliance expectations, and industry practices. Key elements of sterility assurance and contamination control starts from creating a robust and compliant cleanroom design, validation/qualification, operations, environmental monitoring program requirements, microbiological processes/methodology, cleanroom… Continue reading Cleanroom, Microbiology and Sterility Assurance Practices
Read MoreGood Clinical Practice: When Good Studies Go Bad
Good Clinical Practice (GCP) is more than a stack of guidelines and pithy, difficult to interpret language. It is the result of decades of advancement and discovery in medicine; of human decisions both well-intentioned and not; and of consequences ranging from unfortunate to horrific. GCP is a codification of the very hard lessons we have… Continue reading Good Clinical Practice: When Good Studies Go Bad
Read MoreGood Laboratory Practice for Nonclinical Laboratory Studies
Adherence to Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) is critical for ensuring the quality and integrity of study data. Nonclinical laboratory studies (sometimes referred to as preclinical studies) are crucial, and prerequisite, for demonstrating the safety and key aspects of performance of products intended for human use. In this 90-minute accredited ON DEMAND… Continue reading Good Laboratory Practice for Nonclinical Laboratory Studies
Read MoreNavigating the Stability Universe
There is a universe of individuals, departments, and contract organizations outside the direct control of the Stabilitarian which interact with the stability process in ways that can boost or hinder the success of the program. Some of these are obvious while others go virtually unrecognized, yet members of both can impact us severely and deserve… Continue reading Navigating the Stability Universe
Read MoreProtein Formulation and Stability
Many of the new molecules being developed by pharmaceutical and diagnostic discovery groups are biologically based, including monoclonal antibodies, proteins, enzymes, etc. Unlike small molecules, these products are much more sensitive to the normal stresses that a product encounters both over the shelf life of the product and during the manufacturing process. Both the formulation… Continue reading Protein Formulation and Stability
Read MoreEffective and Compliant Technical Writing
This technical writing training program will offer you an understanding of how the reporting process supports products in research, development, and in the marketplace. The 2.5-hour, accredited ON DEMAND training will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train… Continue reading Effective and Compliant Technical Writing
Read MoreComputer System Validation and Part 11 Compliance
Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance. This 90-minute accredited ON DEMAND training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining… Continue reading Computer System Validation and Part 11 Compliance
Read More