All FDA Regulated Industry
Review of Chemistry, Manufacturing and Controls (CMC) of an Investigational New Drug Application (IND)
This webinar is designed to help pharma companies through the various key aspects of the Chemistry Manufacturing and Controls (CMC) information expected by FDA in an IND (Investigational New Drug) Application. The presentation will cover the key aspects of CMC package. And will explore the individual requirements across both the Drug Substance as well as the Drug Product sections of the CMC package.Learning..
Environmental Monitoring (EM) programs for pharmaceutical manufacturing are evolving to a risk-based approach. The use of sampling data for the identification and mitigation of risk becomes a critical element in this process. No longer is it enough to utilize data for reactive excursion reporting.This presentation will discuss how to establish a risk-based Environmental Monitoring Program. During this sessi..
Mr. Yuval Shapiro shall review the basic statistics that are behind the Sample Size selection. Explanations on how to select samples for the Design (verification and validation) phase, and for the Production phase. Also, explanations on how to use the ISO2859-1 for simple cases at production shall be provided. Selection of the correct sample size is a challenging task, especially, when regulatory authorit..
Disasters and disruptions of business rarely occur, but if they do they can be costly and dangerous. In R&D, Manufacturing & Retail areas of a food company, there can be dangerous contaminants and other disasters and important data and business processes that could be lost. Every company has a responsibility to their stakeholders (clients, shareholders, employees) and to regulators, to take steps to..
Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect. For example, while a defect-free process is desirable, a test method must be reliable both in detecting defects and in not rejecting acceptable samples. Those who work with process optimization and validation focus..
This webinar will shed light on all the sponsor’s responsibilities for an Active Investigational New Drug application (IND). Alongside this presentation would detail each of the sponsor’s activity in greater detail including timelines to implement the same. What’s more; the discussion will also detail the safety reporting regulations and associated timelines. Learning ObjectivesUnderstanding each and ..
Manufacturers of foods, drugs, consumer goods, and other products must determine the shelf life of their products so that customers know when the product can be expected to perform as intended. Many approaches are available to quantify the "shelf life" and the method(s) chosen often depend on the testing time available.This webinar discusses the steps to set-up a stability study and analyzes the results to ..
The STED-File with the special format as technical documentation covers a lot of countries and help to have technical documentation in global acting companies. A STED-File collect all the data’s and can help you to keep the overview to deal with this format regarding the several requirements in countries, which required STED-Format e.g. Australia, Canada, etc. Another topic is how to deal with the STED-Form..
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, an..
Sterile Filtration of Pharmaceutical Products - What you need to know to meet Validation and Regulatory Requirements
It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will give you a comprehensive understanding of this important subject with an emphasis on the different types of sterilizing filtration available and their application to your par..
Technical Writing is required by everyone at some point in their careers. All of us must document something that we have written or defended any work that we have performed. Often this documentation takes the form of Technical Documents. The principles shown in the webinar are directed to the pharmaceutical industry but apply to many disciples. Documents are created, reviewed, and issued for many organizati..
This webinar will help personnel in the Analytical Method Development Laboratory, Quality Control Laboratory and Quality Assurance understand the evolving expectations for analytical method validation. The paradigm that test method validation is one experiment performed just before method transfer must be replaced with a proactive, lifecycle approach that includes the three stages of Analytical Method Proce..
This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they require to prepare for and manage FDA inspections. This course provides the rationale, strategies and flows on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.Learning Obje..
The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations! This session will discu..
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..