Compliance Training Webinars for Regulated Industries

This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations.

This Bioterrorism act training will provide the attendee a clear understanding of what is expected, how an investigation will proceed, and how to keep records that will minimize the impact of an incident.

This Regulatory compliance training will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.

This webinar will provide an in-depth understanding of the Federal False Claims Act, Federal Anti-Kickback and Stark laws, and discuss how marketing activities can trigger either or both.

In this webinar you will learn how to determine the Root Cause origin of a problem. You will learn a specific set of steps, with associated tools, to find the primary cause of the problem, so that you can prevent occurrences.

Environmental control of pharmaceutical cleanrooms is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination. Therefore, the design, validation and ongoing monitoring of a cleanroom HVAC system are necessary to assure the quality and safety of the pharmaceutical product. This training program will offer attendees a proper understanding of the cleanroom environment and its testing requirements according to international regulatory standards from a compliance perspective.

The Latin America Regulatory compliance requirement training/webinar will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.

This Japan Regulatory Filing training for life sciences is designed to provide an overview of the regulatory environment in Japan.

This COSO training will provide an in depth look at the Control Activities Component of COSO at the Entity Level. The goals of these principles within this Component are to allow for the Key Controls at various layers and levels within ICFR to reduce risks of achievement of financial reporting objectives.

This JPAL training will describe requirements, common mistakes & best practices while dealing with a JPAL Quality Interface Agreement between the foreign manufacturer and MAH (Marketing Authorization Holder).

This Regulatory compliance training is designed to provide an overview of the regulatory environment in Japan.

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 HACCP training will explain the FSIS regulations and policies program requirements.

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 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 Food Safety and Inspection Service (FSIS) training will guide you through the different levels of enforcement that FSIS utilizes.

This 21 CFR Part 11 training will deliver concrete guidance which will provide a roadmap for compliance that will have immediate benefits, withstand FDA’s changes to Part 11, and discuss the new Obama administration approach to enforcement.

This Food safety compliance training will explain the CCP Decision Tree and help you understand the principles behind each question. We will review various food processing steps in a variety of situations to determine whether they are CCP’s. What is the thought process in determining a CCP? Can it be done consistently? What criteria are used? Are some processing steps always CCP's e.g. heating? If not, why? One thing to remember is the importance of analyzing the hazards at each step very carefully. The more clearly the hazards are described (including equipment failures, personnel errors etc) the easier it will be to find the CCP.

This pharmaceutical training provides a detail review and evaluation of Regulatory requirements on pharmaceutical packaging materials from US and EU. This pharmaceutical training provides a detail review and evaluation of the regulatory requirements for packaging operations including description, suitability, protection, safety, compatibility, performance, Quality Control, supplier, and stability.

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.