Compliance Training Webinars for Regulated Industries

This GLP (Good Laboratory Practices) webinar reviews the process of closing a study by preparing a final report and managing all records and specimens in a proper manner. The GLP final study report represents the last chance for a study team to present their results in a clear and compelling manner. The report may also be a place where difficulties can be explained so that the study provides meaningful and trustworthy information. This webinar reviews the process of closing a study by preparing a final report and managing all records and specimens in a proper manner. It provides two areas of concentration: (1) the best practices in final report writing and (2) the step-by-step process of closing studies.

This IDE (Investigational Device Exemption) webinar will cover its purpose and preparation recommended subject headings and content Submission and follow up Usage in the clinical trial(s).

This webinar describes the importance of and the key elements in a test method validation, including an understanding of its adequacy, range of detection, accuracy, the precision of measurements, and ultimately its robustness and reliability.

This workshop will provide you with the knowledge necessary to apply the COSO model in order to manage your business risk. Today when we talk about internal control, we’re talking about a new standard. Promulgated by the Committee of Sponsoring Organizations (COSO), also known as the Treadway Commission, which has caused a paradigm shift where the emphasis is on identification and management of business risks.This workshop will provide you with the knowledge necessary to apply the COSO model in order to manage your business risk.

This presentation will give an overview of the FDAAA and summarize the new provisions pertaining to specialized pediatric medical device development, food safety, advisory committee provisions, clinical trial registries and drug safety enhancement.

This Medical Device training will describe the information needed to write such protocols, and the basic contents of those protocols. This webinar will provide valuable assistance to all regulated companies that need to validate their manufacturing processes.

This Food Safety Training will assist employees of the food industry in knowing how to legally prepare labels for both FDA and USDA interstate commerce food products. Food labels can be complex for those who prepare and apply them as well as those who simply want to understand the products they are purchasing. Those who create and apply labels must understand the regulations to avoid the potential negative consequences of labeling errors. An inaccurate label can lead to customer or consumer complaints, product recalls, FDA or USDA enforcement actions, fines, and even harm to consumers’ health. Companies need to know how to legally label their products and the accuracy that is required. Those who purchase products should also know what information on the label is mandatory and where to find that information. They should be aware of the level of accuracy required, or not required, regarding the data presented on labels. Does an expiration date mean the product should be thrown out after that date? When comparing items for purchase, is the one with 150 calories better for you than the one with 160? Those responsible for purchasing products to serve in restaurants, hospitals, day cares or schools should know what they are buying based on the data on the label. Understanding the labeling rules will help with purchasing decisions.

In this presentation, we will look at these documents from the investigator’s point of view, reviewing the FDA training manual and actual FDA warning letters and responses. This will reveal what the investigator is trained to look for and what types of problems are actually being discovered in the field offices.

This FDA inspection training compiles the best practices now being used by many companies to host FDA inspections that will satisfy FDA inspectors and result in a good experience for the company. FDA inspections require a large amount of preparation and knowledge. Are you informed enough to avoid Warning Letters

This presentation will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements. This presentation will be aimed at helping Regulatory, Quality Assurance and Quality Control personnel to understand the varying levels of quality activities that accompany early stages of Product development.

This CAPA training provides a process to overcome challenges for Documentation and Conducting CAPA Investigations and integrates FDA requirements and guidelines. "Failure to employ effective CAPA systems can lead to FDA Warning Letters and worse. Accurate documentation is a must – but capturing information from a diverse workforce can be very difficult. Do you have what it takes to meet these challenges?".

Fact: The FDA has noted that 76% of all Warning Letters have CAPA-related issues. This is a significantly large percentage – the results of companies doing a bad job of identifying corrective and preventive actions as well as not validating plan effectiveness.

This Webinar covers REMS provision and Impact on Pharmaceutical Marketers.

This Risk Management training will cover Risk management & Risk assessment within all business processes. Risk management is a concern that must be taken seriously in all aspects of your business. Are you prepared for the problems you may face?

This presentation will discuss the quality-related activities that are expected for Phase 3 products used in clinical studies and the needs of the key demonstration lots that will be submitted with the NDA. This presentation will be aimed at helping Regulatory, Quality Assurance and Quality Control personnel to understand the varying levels of quality activities that accompany early stages of Product development.

This FDA audit training will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Data keeping for clinical research trials involving human subjects has to be as accurate and valid as possible. Does yours meet the mark?

This program will examine the benefits of outsourcing in China along with the risks and review possible solutions needed to enhance supply chain security while consistently delivering safe products to the consumer/patient.

This session will highlight typical manufacturer pitfalls in designing user studies and usability tests as well as common mistakes and omissions regarding use error in PMA and 510K submissions. This webinar will apply to manufacturers with devices that require user-device interactions to set-up, operate, and maintain the device.

This training course will concentrate on how to prepare for the audit, from language and culture to technical requirements and auditor expectations. Due to the 2005 revisions in the Japanese Pharmaceutical Affairs Law (PAL), the PMDA - Pharmaceuticals and Medical Devices Agency - is beginning to step up its scheduling of on-site audits of foreign medical device manufacturers.

This presentation covers the fundamental principles underlying the various compliance regulations and discusses their implications for system designers and integrators. Electronic data capture and management systems for clinical research must support many kinds of research, including clinical trials, prospective observational studies, and retrospective "chart mining". Regulatory requirements for new drug and device trials are the most stringent and complex, but even the smallest investigator-initiated study in an academic health center or community hospital or clinic must comply with human subject protection regulations and professional ethical guidelines, and meet information security requirements such as the HIPAA Privacy and Security Rules. This presentation covers the fundamental principles underlying the various compliance regulations and discusses their implications for system designers and integrators.

We will discuss methods and practices that will improve the clarity and control of your document control system. Effective GMP documentation practices will be reviewed to ensure your paperwork is clear, complete, and easy to understand.