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.
Analytical Methods Validation – 21CFR211.165(e)
One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products today is ensuring that the analytical methods used for analysis can generate valid data upon which business and regulatory decisions can be made. FDA, ICH and USP have each recognized the importance of this to the drug development process… Continue reading Analytical Methods Validation – 21CFR211.165(e)
Read MoreStability Testing – 2 CFR 211.166 (a & b)
In 2006, FDA withdrew both their approved 1987 Stability Guideline and their draft 1998 Stability Guidance and referred industry to the ICH Stability Guidances. In the absence of the detailed FDA guidelines, industry was left to interpret the somewhat ambiguous GMPs. The fact that stability issues continue to be a major cause for regulatory action… Continue reading Stability Testing – 2 CFR 211.166 (a & b)
Read MoreIQ, 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 MoreWriting and Enforcing Effective SOPs Basics
The purpose of this accredited training is to equip participants with the necessary skills for writing effective Standard Operating Procedures (SOPs) that support their company’s activities. Throughout the course, participants will learn how to organize and deliver information tailored to the intended audience and purpose, write documents that are clear and easy to read, and… Continue reading Writing and Enforcing Effective SOPs Basics
Read MoreRheology and Surfactants
Developing products that can properly wet surfaces, disperse pigments, emulsify key components, or generate or destabilize foam is challenging due to the high surface tension of water. Understanding how materials are affected by applied stress forces and their flow behavior is crucial for formulators to develop products with optimal outcomes in terms of production, storage,… Continue reading Rheology and Surfactants
Read MoreEffective Complaint Handling Procedures
This accredited training will provide attendees an understanding of the rules and regulations guiding complaint handling and complaint files within the life science industries. Per 21 CFR Part 820.198, “Each manufacturer shall maintain complaint files‐establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit”. While a product manufacturer hopes to… Continue reading Effective Complaint Handling Procedures
Read MoreStandard Operating Procedure (SOP) and Standard Test Method (STM) Requirements
Designing an effective Standard Operating Procedure (SOP) and Standard Test Method (STM) is the pre-requisite to complying with the different regulations guiding the manufacturing and testing of products. A well-established procedure and test method improves the numbers of manufacturing, testing and personnel deviations which indirectly affects the quality and life cycle process of a manufactured… Continue reading Standard Operating Procedure (SOP) and Standard Test Method (STM) Requirements
Read MoreSelecting Raw Materials for Skin Product Development
Scientific discoveries about Epigenetics and Skin microbiome introduce new families of potential ingredients to the skin care industry. They can be paired with existing ingredients of proven efficacy to boost results. With so many cosmetic ingredients available today, selecting the right ones to include in a formulation can be quite challenging. Without adequate knowledge, the… Continue reading Selecting Raw Materials for Skin Product Development
Read MoreCleanroom, Microbiology and Sterility Assurance Practices
This intensive 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 cleaning/disinfection, trafficking, gowning… Continue reading Cleanroom, Microbiology and Sterility Assurance Practices
Read MoreGood Clinical Practice
The concept of Good Clinical Practice (GCP) goes beyond a mere collection of guidelines and complex, challenging language to interpret. It encompasses the culmination of years of progress and revelations in the field of medicine, encompassing both well-intentioned and misguided human decisions, along with consequences that range from unfortunate to truly horrifying. GCP serves as… Continue reading Good Clinical Practice
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