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..
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..
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..
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..
In a recent study, the FDA has reported a 95% increase in medical device recalls over a nine year period ending in 2017 attributable to a variety of reasons. Whatever the reason, medical device recalls are expensive and most importantly carry significant risk to the health and safety of patients.The increase indicates serious failures in the processes and controls designed to ensure reliability, safet..
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post-production risk management program to be implemented. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard.One of the techniques described in ISO 14971 is Hazard Analysis. This is the most powerful of the risk management techniques becau..
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..
An ANDA is an Abbreviated New Drug Application. This application is submitted to the FDA to seek approvalto produce a U.S. generic drugfrom an existing patented approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs. After approval, the applicant is able to produce and market the generic drug product. A generic drug product is equival..
Good Documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified. This 60-min Webinar covers the essentials of GDP, its definition, purpose, and importance. Then expands on general ru..