Compliance Training Webinars for Regulated Industries

Among other key topics, this training program will focus on what can be monitored in mixing operations, wet granulation operations, dry granulation operations, compaction operations, and coating operations.

Attendees will come away from the training program with the tools they need to understand the various types of enclosures and how to select the correct type of enclosure for their process in order to meet regulations, protect the product, and ensure worker safety. The course is apt for personnel in FDA regulated industries who want to learn about what enclosure is best suited for their process and why.

This training on ISO 14971:2007 will help you understand the risk management process for medical devices, including risk analysis, risk evaluation, risk control and post-production information.

This Clinical trial auditing training will provide valuable assistance how to conduct clinical trials both using internal resources and also those that outsource the function to CRO’s in pharmaceutical and biotech industries. How to assure your clinical trials are in compliance and meet the agencies requirements.

This Sterilization validation training will review the general requirements for validation as described in ISO 11137:2006.

This Product risk management training/webinar for Medical devices will help in to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in the newly revised ISO 14971:2007. The US FDA is increasingly stating that many regulated activities should be “risk-based”. Major resource-consuming activities such as product and process / equipment / facility, and software validation, CAPA investigations, vendor audits can all be tailored to a risk based approach. This eliminates the current SOP-defined “one size fits all” approach, to a flexible, resource adjusted approach, less arbitrarily defined in an SOP, but yielding results targeted to real needs. Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in the newly revised ISO 14971:2007, a standard recognized by the FDA and rapidly being adopted by industry. Then how to use this document to accomplish the above goals.

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 510(k) Training covers the content requirements of a traditional 510(k) application and covers in detail the recommended 20 sections. This 510(k) Training deals only with those medical devices that require a 510(k) application. All Manufacturers introducing Class II medical devices to the US market must submit a FDA 510(k). It is also required for manufacturers that are changing the intended use of the medical device, or changing the technology of a cleared device such a way that it may significantly affect its safety or effectiveness.

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

While simple to describe many companies fall into the trap of territoriality, and confusion of roles and responsibilities. This webinar will walk through the elements of a process validation program for biological products with an emphasis on the involvement of all functions especially process development.

This webinar discusses the use of risk analysis techniques applied to medical device software including discussions of pitfalls in the process of risk analysis. This webinar will provide guidance to medical device companies that need to perform risk analysis on their software products and internal systems.

This risk-based software V&V training will guide you through 11 "must have" elements of software validation and how to use your Risk Management Tools (per ISO 14971:2007).

Learn how to use and how far to go with an effective and efficient approach for your CAPA investigation. This webinar will provide valuable assistance and guidance to all regulated companies that are preparing to use or are currently using risk-based tools for CAPA investigations and closing out investigations in a timely manner.

The Webinar discusses recordkeeping requirements of serious and non-serious adverse events reported to a dietary supplement manufacturer, packer, or distributor. The Dietary Supplement and Nonprescription Drug Consumer Protection Act law mandates reporting to the Food and Drug Administration (FDA) of serious adverse events for dietary supplements.

The presentation will review the complete requirements for Risk Analysis and give an example of how a company can easily create a Risk Analysis in full compliance with the standard. The information will assist in meeting various national and global regulatory requirements for medical devices.

An overview of the new ISO 14971:2007 standard with emphasis on changes from the 2001 version. Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in ISO 14971:2007, a standard recognized by the FDA and rapidly being adopted by industry.

This FDA’s cGMPs training/webinar will provide and insider’s view FDA’s path to restructuring its regulatory oversight of manufacturing quality that is based on quality systems and risk management approaches.

This New Dietary supplements webinar will highlight from a quality perspective the introductory requirements of these new CGMP regulations and examine methods and strategies for meeting these new requirements.

This Risk management training offers a quantitative risk management approach you can use to measure system implementation and enhancement efforts against the criticality and business/regulatory significance of the system.