Compliance Training Webinars for Regulated Industries

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 Biotech training will provide valuable assistance to all regulated companies that need to investigate product issues.

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 ISO 9001:2008 training will provide an understanding of the changes and requirements that Internal Auditors in ISO 9001 certified organizations will need to address to be compliant to the new ISO 9001:2008 revision.

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.

In this Lean six sigma training we will explore what early adopters are doing – and what is on the horizon and a brief history of the evolution both LSS (Lean Six Sigma) in SCM (Supply Chain Management).

This Food labeling training will address all key label elements including the many faces of the Nutrition Facts Panels.

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 Enterprise Risk Management training (ERM) will provide a framework for evaluating the effectiveness of risk management based on an inventory of questions an effective ERM program should be able to answer.

This AS9100 compliance training will provide an understanding of the changes and requirements AS 9100 certified organizations will need to address to be compliant to the new AS9100 Revision C Standard.

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 FDA compliance training will guide you through Software Verification and Validation process in FDA-Regulated Industries. U.S. FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based software V&V. Starting with a Project Validation Plan, evaluating its elements against ISO 14971:2007 hazard analysis / risk management, allows development of meaningful product / process validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, against a background of limited company resources (personnel, budget, time). Two matrices / models simplify regulatory requirements for “as-product”, “in-product”, process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. QMS and 21 CFR Part 11 require yet another approach.