Clinical Trial and Clinical Research
This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process. It will be compliant but not cumbersome or overly time-consuming. The differences between pre-release and post-release change control will be explained. Methods to control the transfer and approval of changes between the company and its suppliers or contract man..
The webinar reviews the general concepts and basic elements of pharmacokinetics, pharmacodynamics, and their correlation. The use of PK/PD for dose selection during drug development will be described also with the presentation of a case study. The use of PK/PD will be described for the evaluation of both drug efficacy and safety. This will illustrate how the model-based drug development and, in particular, ..
This session will include the requirements for all required cross-functional responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "no..
FDA implemented the new Food Safety Modernization Act (FSMA), including the hazard analysis and risk-based preventive in 2016 to help industry manage potential hazards in producing safe food products. Along the way, implementation has taken a few twists and turns, including side-tracking with a pandemic. So, what have we learned along the way and where is the FDA now focused with Food Safety improvements? F..
Personnel in Pharmaceutical manufacturing will be asked to review many different documents. These documents are important, in that, they will be scrutinized by regulatory bodies. The aspects of writing these documents are different. The style of writing is more reader-centric, as opposed to writer-centric. Understanding the aspects of reader-centric writing is important in this industry.Areas CoveredThe Pha..
This webinar will introduce: ways to get on top of all possible questions coming up, how to organize and work organized; and points of possible adaptations, e.g.: disclosing and better training of the important parts of the business process;discrepancies, misunderstandings, and misconceptions; does and don’ts. You must well know the whole process, you are part of, including all technical necessities; ..
Successful autoclave Performance Qualification starts with a fundamental understanding of steam sterilization microbiology. In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to developing a successful autoclave sterilization process.Learning Objectives..
Low-level compound analysis has many differences from that of the more common analyses aimed at major components. The requirements for accuracy and precision are different. Selectivity to differentiate very similar compounds, such as isomers of the various types – substituent positional, optical, alkyl are some – becomes critical since these may differ in toxic effects.The need for definitive qualitative an..
Good Documentation Practices (GDP) is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories, and clinical trials). Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system. This training session will cover the US Pharmacopeia Genera..
The webinar reviews the general concepts and basic elements of pharmacokinetics. The webinar will describe the processes that a drug undergoes after administration such as the absorption (when not administered intravenously), the distribution, including plasma protein binding, the metabolism (the bio-transformation of the drug into its metabolites), and the excretion (via the bile in faces and via the kidne..
FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to make sure it produces a product ..
Even a detailed and well-written standard operating procedure for a method cannot ensure that 2 laboratories running on aliquots of the same will get statistically equivalent results. Using different instrumentation, standards, reagents, solvents, and other chemicals, data systems, sample storage, and handling procedures, and other variables are common and can lead to different results. Making each operatio..
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration
Prior to computer systems and databases, managers and quality personnel created complex visual numbering schemes, cross-referencing methods, and complex filing systems for purposes of retrieval and control. These grew over the years into the extremely complex and convoluted systems we find today throughout the life sciences, including the medical device industry. As is often the case, automation and compute..
Aside from regulatory requirements, liability for the safety of an organization’s food products will be covered. The importance of documentation control is critical in this area. Often logistics organizations do not realize the required FSMA elements, which will be covered in detail. Areas CoveredFSMA (Food Safety Modernization Act), a game changerIt’s about Prevention, ensuring safe food products for..
There are many different types of microbial contamination that can occur in pharmaceutical manufacturing. Some of the sources include water, raw materials, excipients, in-process materials and samples, the manufacturing process, the product itself, the environment, and the like. As such, there is no one size fits all investigation. Microbiological testing covers a wide range of products, processes, and envi..