This webinar bundle consists of 3 webinars, which are designed to provide all FDA regulated industries with the information they require to prepare and manage an FDA inspection. The instructors of these webinars will take you through Mock Audits, SOP Inspections, 483 Response Process, and Behaviour during the inspection, several types of 510(K). This bundle will also teach you to prepare a submission to get..
This bundle of webinars will address approaches to regulatory affairs project management, marketing authorization applications and ongoing management of regulatory obligations. The webinars will also cover batch record review and product release documentation and Breakthrough Therapy Designation, SAE reporting requirements for OTC Drugs, Cosmetics and Dietary Supplements and labeling and recordkeeping regul..
This comprehensive webinar bundle will cover U.S. FDA’s tougher stance and product, process and QMS Validation and Verification, risk-based V&V Master Planning, elements from ISO 14971 and ICH Q9, V&V requirements of ISO 13485, ISO 17025 compliance, Instrumental gas chromatography, conducting supplier audits, Medical Device Hazard analysis, step by step through a typical hazard analysis. The webinar..
4 Valuable Webinars to describe a Compliant Program, Aspectic Techniques And Human Factor Validation of FDA
This webinar package gives you access to 4 webinar courses to brush up your knowledge on Qualification of Suppliers and Contract Manufacturing Organizations, Human Factors Validation Testing Following ISO 62366 and new FDA Guidance, Understanding Aseptic Technique and Cleanroom Behavior, Method Validation of HPLC/ UPLC Methods.The webinar format is 1-1.5 hours of audio-visual presentation, including a brief..
This webinar bundle consists of 4 webinar courses focus on the key aspects of Disaster Recovery and Business Continuity Planning efforts, including best practices and principles for handling this type of work in an FDA-regulated environment, it will also provide guidance on how to keep costs low and avoid “scope creep”, which can lengthen the time and require more money to achieve, learn about FDA oversight..
4 Webinar Courses on FDA Compliance, Clinical Quality Control, Diagnostics, Clinical Data Systems and Computer System Validation
This bundle of webinars will help you to understand the steps needed to transfer, validate and maintain an automated assay in the laboratory, heat sterilization is a PROBABILITY function dependent on heat exposure, the number of microorganisms, and the heat resistance of the microorganisms, the TMF includes all of the documentation that a sponsor must record to demonstrate that they have met their obligatio..
The objective of this bundled Webinar is to teach participants how to develop their domestic and international strategies for effective reimbursement in parallel to achieving Regulatory Approval, to learn the proper way to set up for a Regulatory Inspection, understand in detail the new requirements for labeling from FDA and EMA, Generation of Controlled Documents and Related Training and will also review t..
FDA’s 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries have been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identif..
In this bundled webinar instructors will describe the importance of classifying computer systems subject to FDA regulations in accordance with GAMP, the regulations associated with the detection, correction and prevention of human errors in GMP manufacturing and laboratory processes, also about FDA Regulations Associated with the Detection, Correction and Prevention of Human Errors in GMP Manufacturing and ..
This webinar bundle is ideal for all FDA regulated industries. These webinars will help attendees understand the fundamental steps of deviation investigation with a focus on using facts and objective evidence to arrive at root cause and CAPA. They also focus on how to avoid the pitfalls the mat occur during FDA investigations and help eliminate 482 observations. These courses will help you construct and mai..