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 on HIPAA Breach Notification will show how to create an effective breach notification policy for your organization and how to follow through when a breach occurs. You will learn about the kinds of threats that exist for PHI, information security methods you can use to keep breaches from happening, and be in compliance with the HIPAA Security Rule as well. Why Should You Attend:- The HIPAA Breach Notification Rule has been in effect since September 23, 2009 and most organizations are not prepared to respond to a breach of PHI and report and document it properly. We…

This webinar will help you understand the process, requirements, quality and safety considerations for demonstrating biosimilarity to a Reference Product. You will learn about what type and how much clinical data are needed to support a showing of biosimilarity. Why Should You Attend:- On February 9, 2012, the U.S. Food and Drug Administration (“FDA” or “Agency”) released three highly anticipated guidance documents designed to answer industry questions regarding the development and approval of biosimilars (a/k/a follow-on biologics). The guidance documents provide specific advice and recommendations on steps applicants can take to obtain approval of a proposed biologic product under FDA’s…

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 webinar on documentation and record keeping related to food safety will cover FDA requirements regarding establishment and maintenance of records related to food safety help you make sure you fulfill the FDA's expectations. Why Should You Attend:- Food manufacturers, processors, packers, distributors, handlers, transporters and importers need to become aware of and begin implementation of new food safety record keeping requirements. While the FDA may not have yet clearly stated and established food traceability requirements, they have clearly established record keeping and documentation requirements that allow them to require traceability of all food handling processes and transportation. By citing…

This 4-hr virtual session on social media policies will help you navigate the complexity of how to develop a social media policy that is in compliance with your Legal, Compliance, and HR Department. Why Should You Attend: This workshop will teach you the protocol for engagement on each social network, namely, Facebook, Twitter, Google+, and Pinterest. At the end of this workshop you will be able to develop guidelines for employee usage, and learn how to leverage social networks to increase your visibility among top candidates. You will also learn how to establish your company as an employer of choice.…

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…

This 90-minute webinar will review the 21 basic elements that need to be addressed in the traditional 510(k) submission, as required by the FDA. Why Should You Attend:- The U.S. FDA mandates that the traditional 510(k) submission address 21 basic requirements. The "Special" and "Abbreviated" 510(k)s must also address them, but in different ways. In addition, the FDA Task Force has identified several problem areas with the existing medical device 510(k) process, leading to the growing push by the Agency to strengthen the 510(k) process. What can companies do proactively to address these concerns and better ensure a smoother review…

This 90-minute presentation will cover the FDA Quality System Requirements for software used in medical devices. The presenter will review FDA guidelines on software verification and validation and discuss methods to verify and validate even complex software. Why Should You Attend:- Software problems are now the third-leading cause for recalls of medical devices. Most recalls are because of incorrect verification and validation for safety. Most of the knowledge on how to do a comprehensive V&V is not widely understood. Software design is a complex set of interactions within the device, with the connecting devices, and with users of the device.…

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 full-day virtual seminar on legal issues impacting HRM will provide a comprehensive overview of employment law, key legislation affecting your management decisions and your responsibility to understand and comply with it. You will learn risk mitigation techniques and strategies for ensuring consistency in management practices. Why Should You Attend: Federal, state, and local legislation is often cited by many emerging firms as one of the major barriers to growth. Compliance to these laws covering hiring practices, compensation, employee safety, and labor relations is viewed as a major cost of doing business. Because of the huge expenses related to fighting…

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 :- Sterilization is a critical aspect of device approval and release. Though this is indeed fact, manufacturers sterilize product as a matter of course, without expert sterilization assurance personnel to guide them through potential problems in sterilization. As the world and meaning of CAPA continue to evolve in the medical device industry, further misunderstanding arises when faced with determine root cause and corrective (or preventive) action for any variation in this critical process in device manufacture. The course will begin with an overview of EO sterilization, explaining which aspects of the process often cause confusion. This will be…

This 90-minute webinar will help you understand what the true costs are for completing a clinical study and the unanticipated costs that may arise. You will learn about costs that a sponsor must include in a budget and costs that a site bears in the conduct of clinical research. Why Should You Attend:- Determining an appropriate clinical trial budget to ensure a study can be completed is challenging for both sites and sponsors. Whether you are new to clinical research, or have years of experience, there are 3 areas of expertise you may not have mastered - understanding and outlining…