Life Sciences Regulatory Compliance Training - Live Webinars, Recordings & CDs

This FDA inspection training will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.

This JPAL training will emphasize on Japanese Pharmaceutical Affairs law with respect to - Classification, device approvals, clinical data, MAH (Marketing Authorization Holder),foreign manufacturer accreditation,QMS,post-market complaints & vigilance

This webinar will provide valuable assistance and guidance for medical device companies to ensure they have a well defined, deployed and enforceable design validation program. Did I make the right product and can I prove it is Design Validation! Device manufacturers need to establish and maintain procedures for validating the device design. Design validation has to be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation must ensure that the company’s device or devices conform to defined user needs and intended uses and will include testing of production units under actual or simulated use conditions.

This FDA audit training will review the fundamental aspects of auditing biopharmaceutical API facilities to ensure their compliance with current regulatory guidelines.

This Clinical trial training will focus on understanding the requirements of the new EU Clinical Trial Directive and the issues inherent in any new regulatory process.

This Risk management training will guide you through how to integrate the elements of ISO14971 (Risk management for medical devices) in your design process.

This presentation will discuss the rationale for a process and offer suggestions including definitions and methods for documentation and communication. One of the most common inspection findings is a failure by the Investigator "…to conduct the studies or ensure they were conducted according to the investigational plans". Often, the citation isn't just that the protocol wasn't followed but that documentation surrounding management of the issue is insufficient. Therefore, Sponsors are well served by having an effective process to identify, document, and communicate departures from the investigational plan. This presentation will discuss the rationale for a process and offer suggestions including definitions and methods for documentation and communication.

This Pharmaceutical compliance training will provide instruction on how to establish and maintain a Maintenance & Calibration program for pharmaceutical instrumentation & equipment.

This Quality management training will review processes for integrating a reasonable level of risk management into the quality management system.

In this FDA audit & Inspection training we will focus on ideas that will help identify areas of improvement before the formal inspection occurs. Further, you will learn techniques that will enhance your effectiveness during the audit execution.

This Pharmaceutical compliance training will outline actions to take to ensure the microbiological wellness of your facility and will introduce the concept of "Thinking like a Bug".

This Pharmaceutical training will describe strategies and tactics with concrete examples of how you can set up quality systems that will assure compliance and successful operations and will satisfy the agencies.

This medical device training will guide you through Combination products and overview of clinical benefits, regulatory issues and manufacturing challenges. Medical products, no matter how well designed, can only do so much to address many of the clinical problems today. In order to tackle the clinical problems of the future, medical devices will be used in combination with drugs and biologics (called combination products) to treat a wide range of diseases from heart attack and stroke to Alzheimer’s and diabetes and beyond!

This FDA audit & inspection training will provide your firm with key insights on how to perform superior supplier audits. It will help you uncover purchasing controls GMP violations.

This biotech training will look at different methods to validate the alternate method and Validating of Rapid Microbiological Methods.

This FDA compliance training will provide valuable assistance to all new & existing OTC drug firms that are regulated by FDA due to their domestic USA sales.

This Pharmaceutical compliance training will demonstrate how to implement an effective audit program for both manufacturing and the laboratory and the ability to maintain GMP/GLP/GCP compliance with all suppliers and/or vendors.

This Life cycle management training will provide valuable assistance and gives a process to product design history files and technical files up to date with the new standards through life cycle management.

This Biopharmaceutical training will introduce and link the concepts of GEP and QbD and also identify synergies with the new ASTM E2500 standard Biopharmaceutical Active Pharmaceutical Ingredients (APIs) must be produced according to Good Manufacturing Practices outlined in FDA and ICH guidelines in order to be marketed to the public. This webinar will review the areas that an inspector may examine when conducting an audit of a biopharmaceutical API supplier to ensure it complies with regulatory requirements.

This Medical device training will guide you through Combination products and overview of clinical benefits, regulatory issues and manufacturing challenges. Medical products, no matter how well designed, can only do so much to address many of the clinical problems today. In order to tackle the clinical problems of the future, medical devices will be used in combination with drugs and biologics (called combination products) to treat a wide range of diseases from heart attack and stroke to Alzheimer’s and diabetes and beyond!