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.
Out-of-Specification (OOS) Result Investigation
How to Perform a Compliant, Effective, and In-depth Out of Specification (OOS) Investigation Some FDA (form 483s) and other regulatory bodies inspectional findings, FDA warning letters, product recalls and plant shutdown (voluntary or involuntary) sometimes relate to incomplete, ineffective, and non-compliant OOS investigations that impact a manufactured product. Per the regulations, all Failures, Deviations, or… Continue reading Out-of-Specification (OOS) Result Investigation
Read MorePharmaceutical Semi-Solid Dosage Form: Development, Manufacture & Scale-up
For both prescription and OTC pharmaceuticals, a semi-solid dosage form is a very common delivery method for the drug product. But just because they are common does not mean that they are easy to develop and manufacture. In fact, there are a whole host of issues that can arise during development and manufacture that can… Continue reading Pharmaceutical Semi-Solid Dosage Form: Development, Manufacture & Scale-up
Read MoreStability Testing for Protein Drug Products & Substances
No drug substance or drug product is acceptable without a satisfactory stability profile. Yet, protein drug substances and drug products offer unique challenges when it comes to stability. From storage to handling, to testing, proteins often require thinking creatively to achieve an acceptable stability program. This accredited 12-hour intensive course provides comprehensive and up-to-date knowledge… Continue reading Stability Testing for Protein Drug Products & Substances
Read MoreEffective Approach to Human Error Reduction
Investigations, Root Cause Determination and CAPA Effectiveness If you work in a GMP regulated industry you not only need to address human error deviations because they are an inconvenience, but you must also do it because the regulation requires it. The Code of Federal Regulations (21 CFR 211.22) charge the quality control unit with the… Continue reading Effective Approach to Human Error Reduction
Read MoreData Integrity Practices for the Laboratory and Beyond
Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both. To assure the quality of raw materials, in process materials and finished goods, laboratory… Continue reading Data Integrity Practices for the Laboratory and Beyond
Read MoreOTC Stability Program for FDA Compliance
In 2006, FDA withdrew both their approved 1987 Stability Guideline and their draft 1998 Stability Guidance and referred industry to the
Read MoreHPLC (High Performance Liquid Chromatography): Basics – 101
HPLC is one of the most widely used and versatile analytical instruments in the laboratory today. Because of the many different modes of operation, it can be difficult for many to understand some of its complexities. But with proper training, HPLC can be the tool of choice for the analytical chemist. This HPLC course is… Continue reading HPLC (High Performance Liquid Chromatography): Basics – 101
Read MoreHPLC (High Performance Liquid Chromatography): Method Development
This HPLC course will benefit the personnel with some HPLC experience who are developing or optimizing HPLC methods. This 90- minute accredited course will include discussions of the theory of Reversed and Normal Phase, Ion Pairing, and Ion-Exchange Methods. It will also give basic starting points on method development and method evaluation of these methods.… Continue reading HPLC (High Performance Liquid Chromatography): Method Development
Read MoreHPLC (High Performance Liquid Chromatography): Method Development of Peptides and Proteins
This 90-minute accredited ON DEMAND course will include discussions of the theory of SEC, Reversed Phase, Ion-Exchange, Hydrophobic Interaction, and Protein Affinity Chromatography. It will also give basic starting points on method development and method evaluation of these methods. The course is designed to give personnel with some HPLC experience a broader scope for how… Continue reading HPLC (High Performance Liquid Chromatography): Method Development of Peptides and Proteins
Read MoreIntroduction to Validation Principles, Practices and Requirements
FDA regulated industries utilize several types of validation to help ensure the quality of their products and to comply with FDA and international regulations and requirements. This 12-hour, accredited ON DEMAND course provides an overview and introduction to Validation principles and requirements. Discussed in this program are: -Process validation -Computer System Validation -Cleaning validation -Methods… Continue reading Introduction to Validation Principles, Practices and Requirements
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