FDA Risk Management Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will discuss the FDA requirements for pharmacovigilance and complaint evaluation under GMP

This webinar will demonstrate how to use requirements tractability to systematically connect Engineering, Manufacturing and Risk Management processes, and how to systematically collect the objective evidence necessary to prove 21 CFR 820 compliance to the FDA.

This training program will discuss risk management and outline the requirements for applying risk management to the quality system. It will also discuss how to conduct and implement risk management practices at your firm and review communication techniques to highlight the benefits of risk management.

Usability Engineering has become a major topic. The current standard tightens the linkage to risk management. In addition, there are changes in the US and EU approach, all of which find a basis in this standard. Attending this presentation provides the information you need to prepare for these major changes.

This 90 mins webinar will provide a thorough understanding of the range of FDA enforcement options and the criteria the agency applies in deciding which to use.

This Webinar will present the best practices for integrating medical device risk analysis into a quality system. This integrated processes spans new product development, design change, production, and post market surveillance for the lifecycle of the device. Objective evidence produced by the integrated processes can be used to demonstrate risk analysis compliance to 21 CFR 820 and ISO 14971 during an audit.

This presentation gives you the essential information you need to write a successful plan. Many companies try to implement Risk Management using an inadequate Risk Management Plan. They often leave out required items or add additional, but unnecessary information. The Risk Management Plan is key to an efficacious project to ensure your device is safe and meets the regulatory requirements.

This webinar will review the classic objections to Agile practices and explain how to overcome them. We will discuss real-world examples of medical device companies currently employing Agile approaches and understand how you or your company can gain similar benefits.

This training program will address the daunting task of conveying complex technical data clearly, concisely, and purposefully to technical and non-expert audiences alike. Writing examples from diverse technical fields makes this webinar highly relevant. The program will build a foundation for learning by identifying the qualities of effective writing and the roadblocks to overcoming them.

This training program will explore why human factors has become a vital part of the FDA’s medical device pre-market approval/clearance process. The FDA Center for Devices and Radiological Health (CDRH) recently issued two guidance documents on human factors that are key elements in determining pre-market submission strategies for manufacturers. In this webinar, attendees will learn how to provide clear and complete human factors submissions meeting the intent of these guidance.

This webinar will cover the current FDA requirement for raw materials used in producing APIs and drug products. Attendees will learn how to ensure that raw materials are of acceptable identity, quality and purity before use. This webinar will also provide best practices for avoiding FDA warning letters and 483 observations.

This webinar will help attendees evaluate their existing Quality Management System (QMS) in light of the changes in the FDA's CGMP / QMS enforcement paradigm. Attendees will learn how to document a risk-based QMS at their organization for both compliance and cost savings.

This FDA compliance training will discuss major changes in FDA enforcement and how the regulated industry should respond to any FDA inspection activity.

This Spreadsheet validation training explores strategies for recognizing when validation is required, how to achieve compliance and what documentation needs to be generated and maintained.

This 3-hr training on South Korean regulatory compliance requirements for life science products will discuss about the regulatory structure, clinical trial requirements and the conduct of running clinical research in South Korea.

This 90-minute webinar will provide you a thorough understanding of the updated framework surrounding Good Pharamcovigilance Practices (GVP) in the EU. This will include updates to the EU regulation, Directive and the first seven PV Modules, which have been published for consultation.

This Japan Regulatory and Clinical Trial Requirements training will cover Japan Regulatory Agency Structure and Responsibilities, its review process for decision-making and approval, requirements for clinical trials in Japan and the procedures for conducting clinical studies in the country and reporting them.

This FDA compliance training will be valuable who are involved in the development of REMS and who are planning a submission and need to understand what might be required by FDA and how to comply and for those who have Risk Management Plans.

This Cleaning validation training will provide valuable assistance to all regulated companies that need to develop and validate their equipment cleaning processes. This session will address risk-based approaches to cleaning validation studies using ICH Q9 and recent FDA comments and observations as a foundation. Recent FDA warning letters illustrate just how critical good cleaning practices are. Understanding and employing good cleaning practices are instrumental to improving cleaning consistency, quality and traceability. The FDA favors automated CIP systems since they reduce operator variability while enhancing consistency and reproducibility. Our research has indicated that in the last 5 years, cleaning citations were noted in 50% of warning FDA letters. Many cited contamination issues have an element of poor cleaning practices associated with them. Examples include “investigations…did not include an evaluation of the cleaning processes and procedures…to determine if equipment cleaning is effective in preventing cross contamination of the inactivated batches”, FDA Warning Letter, Jan 2008; "vaccine manufacturing plant in Pennsylvania, has been served with an FDA warning letter asking for measures to ensure batches of its flu shot ingredients do not become contaminated again.” Jul-2006..

An overview of ICH risk management techniques and how to apply them to equipment cleaning programs will be discussed. In addition, case studies from manufacturing facilities will be used to illustrate risk-based cleaning validation principles and practices.

This presentation explores strategies for recognizing when validation is required, how to achieve compliance and what documentation needs to be generated and maintained.