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…

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 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 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 ICH Q10 training /webinar will discuss the evolution and interpretation of the pharmaceutical GMPs as a quality control regulation to the Quality Assurance emphasis of the Pharmaceutical Quality System as defined in ICH Q10. Why should you Attend: Since the release of the Quality System Regulation for medical devices, the FDA has been trying to transition the pharmaceutical industry to a Quality System approach to compliance. The issuance of the Guidance for the Industry: Quality System Approach to Pharmaceutical CGMPS and ICH Q10. Pharmaceutical Quality System has brought new focus to Quality Systems in the pharmaceutical industry. This seminar…

Understand the steps of a extractables / leachables study, get knowledge about the gap analysis of literature sources and how to design an efficient E/L study. Why Should You Attend:- The FDA industry guidance for container-closure systems for packaging human drugs and biologics requires the testing of container closure components for extractable leachable for all injectibles. Since biologics products are particularly sensitive to leachable there has been increased scrutiny of extractable and leachable associated with biotechnology drug products. The time and resources required for testing for extractable/leachable can be conserved by appropriately planning the study. This interactive webinar will provide…

This webinar will help you understand how non-IND clinical trials at non-US locations can be used successfully to support an IND/IDE or a marketing approval application. It will cover the critical product specific issues (drugs, biologics, diagnostic kits and medical devices) that need to be addressed when using non-US data for discussions with FDA. Description :- FDA acceptance criteria for non-IND/IDE clinical trials are based on internationally recognized standards of quality, ethics, and practices for human subject protection. An adequately designed non-US study can be used to greatly reduce the time of cost of getting the tested product to the…

Course Description: This 2-day on-site Course will help you gain a comprehensive understanding of the Regulatory Structure, Clinical Trial Requirements and the Conduct of Running Clinical Research in Japan and South Korea. It will prepare you for the regulatory approval processes, Agency meetings, the complexities of running studies in both countries, the importance of partner selection and the cultural knowledge needed for success. The recent changes made by PMDA and KFDA to be more sponsor-friendly will be reviewed. Real world experiences on actual interactions with the Agencies since these changes, will also be discussed. Who will Benefit: This course will…

This webinar will help you understand the significant differences between qualification and validation of an analytical method, the expectations and requirements of each, and their place in the analytical method lifecycle. Why Should You Attend:- Execution of a method validation is a resource intensive activity, both in terms of manpower, equipment usage, time, and money. The more the process is well defined and understood, the greater the potential for an efficient project. The less the process and its elements are understood, the greater the chance for delays and additional resource expenditures. There is confusion and a lack of guidance over…

This 2-hr webinar will review the FDA and FTC regulations for promoting and advertising dietary supplements, walk you through real-life case studies, help you address compliance, and tell you how to respond to an FDA enforcement action. Why Should You Attend:- FDA and FTC routinely initiate enforcement actions, including Untitled Letters, Warning Letters, Recalls, etc., against dietary supplement makers who misbrand their products by violating FDA advertising and promotion regulations, e.g., by claiming the product can treat, cure, prevent, mitigate or diagnose disease. Sometimes the Department of Justice gets involved and prosecutes firms on behalf of these agencies for violations.…

This webinar on Risk Evaluation and Mitigation Strategy (REMS) will help you understand how to adhere to REMS policy, its implementation and submission requirements. It will discuss FDA's current thinking on REMS, how it reduces the REMS obligations for sponsors, and how the agency's requirements and procedures in this area are evolving. Why Should You Attend:- Risk Evaluation and Mitigation Strategy (REMS) continues to be a critical part of the FDA’s focussed efforts to increase safety of marketed products (drug or biological). As such they are enforceable by civil monetary penalties of up to $250,000 per violation that can continue…

Course Description :- Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Finding efficiencies without weakening the quality position is essential. This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.Attendees learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation. The instructor addresses the latest computer system industry standards for data security, data transfer,and audit trails. Students see how 21 CFR Part 11, the FDA regulation pertaining to use…

This webinar presents a best practices approach for preparing, characterizing and storing cell banks used for GXP analytical and bioanalytical test methods. It covers critical topics such as timelines for generation of cell banks, equipment, growth conditions, purity, consistency, and stability. Why Should You Attend:- Cell-based assays are routinely used during biopharmaceutical development for the assessment of product potency, the determination of pharmacokinetic and pharmacodynamic profiles and the detection of neutralizing antibodies, among other applications. The accuracy and reliability of test results generated by these methods is critically dependent upon the production of controlled and consistent cell banks. Learning Objectives:-…

This 90-minute webinar on sampling plans using ANSI/ASQ Z1.9 will explain the methods in Z1.9 and shows how to use it in a more modern setting (using simple statistical calculators). Why Should You Attend: Many companies use attribute sampling plans at incoming, in-process, and final inspection. The common approach uses ANSI/ASQ Z1.4. There is an alternate, however, that may reduce cost. Sampling plans based on ANSI/ASQ Z1.9 can reduce cost by requiring smaller sample sizes. Z1.9 is an effective and efficient method for acceptance sampling. Because it retains the methods required before calculators and spreadsheets, the standard appears overly complex.…

The objective of the Sixth International Conference on Environmental Science and Technology will be to provide a major interdisciplinary forum for presenting new approaches from relevant areas of environmental science, to foster integration of the latest developments in scientific research into engineering applications, and to facilitate technology transfer from well-tested ideas into practical products, waste management, remedial processes, and ecosystem restoration. Environmental humanity and sociality such as environmental ethics, environmental law, environmental economy and environmental management are also included in the scope of the conference. Researchers, engineers, site managers, regulatory agents, decision-making officials, consultants, and vendors will all benefit from…

Learn FDA requirements for 21 CFR Part 11, understand how to implement with the help of SOPs and case studies. Why Should You Attend: Though FDA's new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations. Just in 2007/2010, there have been about 30 Warning Letters related to Part 11 compliance, some with disastrous consequences for inspected companies. It seems that 'enforcement discretion' as stated in the 2003 guidance is not applied any more. Also FDA's computer expert John Murray recommended at a…