Timely, accurate analytical data is essential for determining success in chemistry. Even with years of education and experience, chemists often encounter seemingly unsolvable challenges. That’s when other perspectives – especially from informed and helpful experts – can make all the difference.
Our in-depth course can strengthen your skills and knowledge of chemistry, instrumentation, and statistics to solve pressing problems. Increasing your capabilities in analysis, process and product development, and fundamental laboratory research can open the path forward for your career.
Good Documentation Practices for Laboratory Records
In FDA’s Guide to Inspections of Pharmaceutical Quality Control Laboratories (7/93), it is stated The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. A significant portion of the CGMP regulations (21 CFR 211) pertain to the quality control laboratory and product testing. Good documentation practices are expected… Continue reading Good Documentation Practices for Laboratory Records
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 MoreLaboratory Controls: Anticipate the Systems Based FDA Inspection
Many QA and QC personnel in the pharmaceutical industry are not familiar with the FDA systems-based inspection model. They are also not aware of the types of 483 observations that many FDA auditors make today. One of the most scrutinized areas during these inspections is the laboratory. Because of this, it is important for lab… Continue reading Laboratory Controls: Anticipate the Systems Based FDA Inspection
Read MoreHPLC (High Performance Liquid Chromatography): Method Development of Peptides and Proteins
This accredited 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 to use this… Continue reading HPLC (High Performance Liquid Chromatography): Method Development of Peptides and Proteins
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 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. The course… Continue reading HPLC (High Performance Liquid Chromatography): Method Development
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 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 MoreCMC Writing and Submission Strategies
The CTD is the basis of drug, biologic, and drug-device combination registration applications. A proper understanding of CTD writing strategy and health authority expectations can greatly aid a company in gaining approval. With the prerequisite complete, this accredited training, will provide in-depth instruction on Chemistry, Manufacturing, and Controls (CMC) requirements and review processes for clinical… Continue reading CMC Writing and Submission Strategies
Read MoreAnalytical Methods Validation for FDA Compliance
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 for FDA Compliance
Read MoreSterilization Professionals Certification Program
In the FDA’s Guide to Sterilization Process Controls, the FDA stated five (5) key inspectional objectives which are used by the agency during routine inspections of sterilization and sterility assurance processes. One of the key areas of concern pertains to the production and process control subsystem (including sterilization process controls) which requires that manufacturers of… Continue reading Sterilization Professionals Certification Program
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