Drugs & Chemicals
How Successfully Apply for a Breakthrough Therapy Designation
The Breakthrough Therapy Designation (BTD) is perhaps one of the most impactful incentives from the FDA as it helps get the product to market much faster than any other expedited approval pathway. Once a drug is successful in getting the BTD, the non-clinical and clinical requirements for market approval are significantly reduced. The applicants can request special meetings with FDA to discuss the developme..
How to Make Design Part of Your Product Development DNA
Getting your development team to move forward in a cohesive fashion can be hard. Engineers and designers can have different goals and methods during a development project. In this session, we will explore ways to embark on design research work that will fuel the product development work down the road, and learn a few things about creativity and our brains. The methods discussed will enable participants to d..
How to prepare a standard operating procedure (SOP)
Standard Operating Procedures (SOPs) are required for companies that are regulated. However, there is no guidance available by regulatory bodies on how to write, maintain, and update SOPs. Often, SOPs are prepared in a way that makes compliance difficult, leading to errors or delays that will be discovered during an audit. Technically, all FDA inspections include an SOP review and it is very important to ha..
Human Error Reduction in GMP & Manufacturing Floor
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrenc..
Human Error Reduction Techniques For Floor Supervisors
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allow it. To work with these challenges, it is essential to understand human behavior and the psychology of error as well as understand exactly where the ..
Human Factors and Ergonomics in New Product Development: Methods and Technique
Human factors engineering is extremely integral to user/market adoption. Getting a product to market is difficult whether you are a struggling startup or an established original equipment manufacturer (OEM). Understanding some of the tools available on the front end of product development can help you avoid downstream problems before they become time and money wasters. Human factors engineering is one such ..
Implementing a Quality Management System
The Quality Management System (QMS) is a set of policies and protocols for the acceptable operation of an organization that contains laboratories that must comply with US FDA GLP. Examples of roles and responsibilities, useful metrics, and tools to monitor performance, and useful documentation will be given.Learning ObjectivesGLP RegulationsQuality Management System (QMS)DefinitionPrinciplesPurposeFunctionE..
In Depth Testing of Computer Systems Regulated by FDA
We will discuss the importance of applying industry best practices when performing the validation process for a computerized system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process). Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly. Testing is a very large co..
Laboratory Investigation of Out-of-Specification (OOS) Results
Inadequate investigation of out-of-specification (OOS) results in the laboratory is a common observation cited in FDA 483s and Warning Letters. It is clear that regulatory investigators throughout the world are looking at laboratory operations very closely. Specifically, there is a concern as to whether the laboratory and the company apply good science to the investigation of laboratory test results that ar..
Legal, Regulatory and Policy Issues Related to Validation of Computer Systems Regulated by FDA
We will discuss the importance of applying industry best practices when performing the validation process for a computerized system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process). Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly. There are legal, regulator..
Managing an FDA Foreign Inspection
Agreeing to an FDA foreign inspection requires careful preparation on a firm’s part. If you do not manage your inspection wisely, you will set yourself up for disaster. We will cover fundamental issues, such as pre-inspection tasks, preparing your documents and having an interpreter before, during and after the inspection. We will also address how you should respond to inspectional problems noted by the FDA..
Managing The Audit Function In A Global Company
Whether your company is small or large each should have at least one independent yet experienced individual or department that can be relied on to resolve issues from these and other perspectives: quality assurance, regulatory affairs, and corporate risk management. While companies rely on audits to remain in compliance everyone is eventually faced with a complex issue that requires examination from an..
Medical Device Software 62304 Compliance
The webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards. You will learn about what must be done and what must not be done. In addition, you’ll learn about the various computer system validation deliverables and how to document them. This session will provide insight into the IEC 62304 standard as it is applied to medical device sof..
Modeling and Optimizing Process/Product Behavior using Design of Experiments
Experimentation is frequently performed using trial and error approaches which are extremely inefficient and rarely lead to optimal solutions. Furthermore, when it’s desired to understand the effect of multiple variables on an outcome (response), “one-factor-at-a-time” trials are often performed. Not only is this approach inefficient, but it also inhibits the ability to understand and model how multip..
New FDA and EMA Labeling Requirements for Regulated Industries
This webinar will help you understand in detail the new requirements for labeling from FDA and EMA, including a set of rules for electronic submission of labeling content, and strategies and actions for meeting the new challenges posed.Pharmaceutical companies must manage the process of designing and creating product labels that meet regulatory requirements. This includes product-labeling documents such as ..