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.
Good Laboratory Practice for Nonclinical Laboratory Studies
Complying with the principles of Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) is of utmost importance to ensure the reliability and credibility of study data. Nonclinical laboratory studies, also known as preclinical studies, play a vital role as a prerequisite for demonstrating the safety and essential performance aspects of products intended for human use.… 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 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. This 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 you on effectively reviewing… Continue reading Effective and Compliant Technical Writing
Read MoreAuditing Stability Programs
A significant number of 483’s and Warning Letters related to the stability function is proof that not all companies have an adequate program in place. Since regulatory requirements and guidance’s provide only a general picture of expectations for stability programs, much interpretation is left up to individual companies. A better understanding of regulatory expectations and… Continue reading Auditing Stability Programs
Read MoreCleaning Validation: Best Practices
Cleaning validation is one of the many GMP requirements critical to the production of a drug product or medical device. Unfortunately, product recalls due to inadequate cleaning still occur, indicating that implementation of an effective and compliant program is lacking in some companies. Because costly regulatory actions can have a significant negative impact on a… Continue reading Cleaning Validation: Best Practices
Read MoreEnsuring Your Supply Chain through Supplier Qualification
The Covid-19 pandemic highlighted the significance of effectively managing pharmaceutical and medical device supply chains. Previously hidden or overlooked vulnerabilities in the supply chain led to production disruptions and, in some cases, product shortages. To ensure regulatory compliance and sound business practices, supplier qualification is the foundation of effective supply chain management for pharmaceuticals and… Continue reading Ensuring Your Supply Chain through Supplier Qualification
Read MoreGXP Foundations
GXP represents a collection of regulations and guidelines that encompass best practices for various crucial aspects of medical product development. Due to the intricate regulatory environment and the distinctiveness and diversity of medical product innovations, it can be challenging for sponsors to establish a framework for product development and marketing that satisfies regulatory requirements while… Continue reading GXP Foundations
Read MoreExcipients: Compliance with Compendial and GMP Requirements
Excipients are crucial in the manufacturing and formulation of bio/pharmaceuticals, enabling medicines to be delivered to patients in need. Compliance with appropriate quality and regulatory requirements is essential for companies that manufacture, distribute, and use excipients. The United States Pharmacopeia-National Formulary (USP-NF) requires that official substances be prepared according to recognized principles of good manufacturing… Continue reading Excipients: Compliance with Compendial and GMP Requirements
Read MoreAn Introduction to the Preparation, Packaging and Labelling of Clinical Trial Supplies
Clinical studies are essential to ensuring the safety and effectiveness of new drug products before they are launched. The cornerstone of these studies is the clinical supplies, which must be properly labeled and prepared to ensure patient safety as well as prevent expensive clinical trial delays. To provide a high-level overview and introduction to the… Continue reading An Introduction to the Preparation, Packaging and Labelling of Clinical Trial Supplies
Read MoreEthnic Skin and Skin Pigmentation
Companies which consider pigmentation as the only important parameter in developing ethnic skin products miss an excellent opportunity to develop a truly elegant and effective product that delivers to the consumer so much more. This accredited online course will summarize some of the physiological differences between skins of different ethnicities, of which melanin content and… Continue reading Ethnic Skin and Skin Pigmentation
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