This 90-minute webinar on device corrections and removals will clarify your obligations for corrections and removals under Part 806 of the FDA regulations. Why Should You Attend: When your firm finds a problem with a device you shipped and fixes it, do you report it to the FDA? If you send a letter to a customer that says, “We found a problem, but, not to worry, we will fix it for you!”, you may have invoked the Corrections and Removals process. Under Part 806 of the FDA regulations, you must report this event to FDA. Under certain circumstances, you may…

This training will provide a practical methodology for creating and applying Risk-Based Equipment Validation. It will show an example of how this process may be integrated into a facility Master Validation Plan. Why Should You Attend: In installing equipment, how much validation is enough? How much is too much? Risk-Based Validation establishes rules for what is appropriate and is the FDA-preferred method for determining what qualification protocols are required. It is based on the intended use of the equipment and the impact it may have on regulated processes, safety and quality. This presentation teaches a practical methodology for creating and…

This webinar on clinical trial audit/ inspection preparedness will discuss in detail about applicable regulatory and sponsor requirements, guidelines and SOPs, and how you can ensure that the conduct of clinical research at the investigative site(s) complies with them. Why Should You Attend:- Significant audit/inspection findings expose you and your organization to regulatory or contractual sanctions, including but not limited to – discontinuation, disqualification, seizure, injunction and/or civil money penalties. Your position, as a clinical research professional, has an important role in your organization’s preparation for and success at audits/inspections, and it is your responsibility to know how to ensure…

This webinar will cover techniques and process that can help you assure reliability and consistent quality from your suppliers or contract manufacturers. You will learn how to monitor your supplier and ensure they meet FDA's quality requirements. Why Should You Attend:- No matter where a product is manufactured, quality is the responsibility of the organization whose name appears on the label. If you hire a contract manufacturer to make products that will carry your label and your name, the responsibility for the quality of that product is yours. There are many things that you can do to assure quality and…

This 21 CFR Part 11 training will analyze the regulations and provides concrete guidance on compliance for Electronic Medical Records. Description:- Electronic Medical Records are the future. Some facilities and doctors are already using this cutting edge technology, and the medical community in general is moving in this direction. FDA regulations governing electronic records and electronic signatures will be enforced upon these systems as they are used and become more prevalent. This presentation analyzes the regulations and provides concrete guidance on compliance. Areas Covered in the seminar:- - Review of current status of 21 CFR Part 11. - What is…

This 90-minute webinar will help you understand the problems that can occur with statements by pharmaceutical manufacturers directed to off-label uses of pharmaceuticals. Why Should You Attend: Off-label uses cannot be legally promoted. Promoting off-label uses may be viewed by FDA as actionable under the False Claims Act. Criminal and civil liabilities can be substantial for manufacturers. One recent settlement agreement with FDA went into the hundreds of millions of dollars. Social media increases the chance for interaction between pharmaceutical manufacturers and patients (and others) like never before. Manufacturers are increasing in a position to responding to unsolicited requests for…

This webinar will provide you with an overview of risk factors in clinical trials and discuss possible ways to mitigate, control, assess impact, and prevent them in your trial. Why Should You Attend:- If you are currently involved in clinical trials either as a CRA, project manager, investigator or sponsor, this webinar will provide you with an overview of risk factors in clinical trials and possible ways to mitigate, control, assess impact, and prevent them in your trial. We would discuss the key elements of risk management such as planning, identification, quantification, action, measurement, outcome assessment, and post-implementation review of…

Course Description :- All pharmaceutical, biologics, and medical device facilities are likely to have high purity water systems. In spite of this purity, microorganisms can flourish within these systems and lead to undesirable contamination of facility processes and their products. Of all the individuals at the facility who should understand the microorganisms in water systems and how best to monitor and control and them, it should be the site’s microbiologists. Sadly, this is often not the case due to the lack of familiarity with biofilm and its impact on water system sampling, testing, sanitization, and routine maintenance. This course is…