http://www.worldconferencecalendar.com/index.php?option=com_conference Fri, 18 May 2012 00:05:41 +0100 FeedCreator 1.7.2 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,9/adid,3362/Itemid,26/ Being up-to-date with current requirements and understanding individual authority interpretation of guidelines is critical for successful product registration. The challenge in Asia is the frequency of changing regulations and increasing time-lag for regulatory approval – factors which can significantly impact on your time to market and bottom line. IBC’s Pharmaceutical Regulatory Asia Summit is the longest standing event of its kind in the region. In our 5 th year, we are emphasizing collaborations between industry and authority to expedite the approval of safe and effective drugs. In this event you will not be presented with a series of regulatory checklists that you can find online. What you will gain is:  Real-life industry experience in dealing with particular authorities  More opportunity to engage in Q&A discussions with regulatory authorities and industry experts  The chance to ask questions that you want answered to expedite your own approval process What’s New for 2012  More speakers than ever before: Learn from and network with 30+ regulators & regulatory professionals  First-time! EU Regulator discussing latest updates and future impact in Asia  New Pfizer case-study: Seeking operational excellence in delivering global submissions  First-time! Lessons learned from implementing a new streamlined submission process at the TGA  New formats allowing for more interaction, collaboration and discussion: Meet the Regulator Q&A, In-depth China & Key Growth Markets round-tables, strategy sessions in the Discussion Den - Health and Medicine Thu, 17 May 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,9/adid,3361/Itemid,26/ Overview: This course will present, in one place, the regulations and guidelines that apply to early phase products. In some cases these will not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. The course will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials. Why should you attend: Any pharmaceutical worker who must deal with products both in early and latter phases of development should attend this course in order to be aware of the regulatory requirements that will affect operations dealing with these products. The modifications to the GMPs for early phase products have modified the GMPs in such a way as to reduce requirements to allow more efficient work. At the same time some of the things that may appear to have changed, have not, and the pharmaceutical worker should be aware of this. Seminar Content: India Seminar 2012 at Mumbai: Day 1 - 18th June 2012 • Lecture 1: Very Early Stages • Lecture 2: What the ICH Q8 Annex covers • Lecture 3: GLP requirements • Lecture 4: GLP-based Animal Studies Day 2 - 19th June 2012 • Lecture 5: Early Pre-IND Studies • Lecture 6: The Preclinical/Clinical Interface • Lecture 7: The Animal Rule and Orphan Drugs • Lecture 8: Pediatric considerations Day 3 - 20th June 2012 • Lecture 9: GMPs for Phase 1 Products. Part 1 • Lecture 10: GMPs for Phase 1 Products. Part 2 • Lecture 11: Phase 2 Products Who Will Benefit • Presidents • Vice Presidents of Technical Departments • Managers • Directors • Regulatory Associates and Analysts • Quality • Regulatory • Research • Development Group Heads About Speaker: Dr Steven S. Kuwahara currently heads GXP BioTechnology . He is an experienced analytical biochemist who has applied his knowledge to the quality control area of pharmaceuticals. His work has dealt with all aspects of GMP and GLP in relation to drugs and biopharmaceuticals. He has worked with small molecules, proteins, cells, gene therapy vectors and nutritional supplements. Dr. Kuwahara has written many papers and book chapters, and serves on the editorial advisory boards of BioPharm, BioQuality, Journal of Validation Technology, and Journal of GXP Compliance. For the last of these, he also writes a column called “The GLP Forum.” He has held certifications such as CQA, CQT, and CQE from the American Society of Quality, and was certified RAC by the Regulatory Affairs Professionals Society. DATE AND VENUE: 18th, 19th and 20th June, 2012 at Mumbai Conference Timings: 9:00 am - 6:00 pm Intercontinental The LaLit, Sahar Airport Road, Andheri East Mumbai - 400059 INDIA Price – Rs18000 Contact Information: Event Coordinator Toll free: 1800 425 9409 Phone number: +91 80-3221-3341 / +91 80-3247-3696 /+91 80-3221-3329. FAX : +91 80-2642-1483 Email: customersupport@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com GlobalCompliancePanel NetZealous Services India Pvt. Ltd. 4th Floor, A, Block, Brigade Software Park, Banashankari 2nd stage, Bangalore-560070. INDIA. Link: http://bit.ly/LVLL7l - Health and Medicine Thu, 17 May 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,9/adid,3357/Itemid,26/ IMMUNO2013 is a leading immunosuppression conference that provides researchers and practitioners with the latest developments in the fields of Immunosuppression, Immunomodulation and Immunotherapy. The conference will facilitate networking, the exchange of knowledge, and opportunities to learn from world experts. - Health and Medicine Wed, 16 May 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,9/adid,3356/Itemid,26/ The 10th International Congress on Coronary Artery Disease (ICCAD 2013) is a CME-accredited forum aimed at researchers and clinical practitioners in cardiovascular disease. ICCAD gatherings have developed a well-earned reputation for providing participants with a platform to exchange ideas relating to coronary artery disease. - Health and Medicine Wed, 16 May 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,9/adid,3355/Itemid,26/ Join world-renowned experts for the most advanced research and techniques in gynecologic cancer patient care. - Health and Medicine Wed, 16 May 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,9/adid,3346/Itemid,26/ This 90-minute webinar will discuss the new FDA "Global Engagement" Initiative for new areas for heightened CGMP compliance from U. S. FDA-regulated companies and their global partners. It will cover areas for increased awareness, focus, and remediation, and the approaches that are now mandated. Why Should You Attend:- The last two years have seen major initiatives at the FDA; as well as prominent drug and device failures over cGMP issues, resulting in recalls, lawsuits, class action lawsuits, and even possible criminal prosecution. The FDA sees globalization as a growing reality, and potential contributor of major regulatory issues: the supply chain, counterfeiting, clinical trials, other global outsourcing actions; by global / multinational corporations. A new paradigm for FDA guidance and strengthened enforcement is called for. Areas Covered in the Seminar:- - The U.S. FDA's New Global Engagement Initiatives. - Recent global industry trends, bad and good. - Major foreseeable problem areas. - How the FDA initiatives impact regulated industries. - Immediate actions to take. - Long-term correction / preventive action of FDA-defined problem areas. - Health and Medicine Tue, 15 May 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,9/adid,3345/Itemid,26/ 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 process? Areas Covered in the Seminar:- - The Three Types of 510(k)s and Their Uses. - The 21 Required Elements in the 510(k), and How Documented. - Finding, Proving and Documenting Substantial Equivalence. - Addressing Product "With-" or "As-software" Issues. - The "Statement" or The "Summary". - Health and Medicine Tue, 15 May 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,9/adid,3324/Itemid,26/ This international gathering aims to translate the latest findings in the field into clinical practice. Nurses interested in broadening their horizons will find in COINN 2013 a top calibre scientific programme simultaneously tailored for the specialist as well as the general nurse. Join nurses who share your passion for neonatal care in Belfast, 5th-8th September, 2013. - Health and Medicine Sun, 13 May 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,9/adid,3323/Itemid,26/ Join us in Florence, Italy for Pain in Europe VIII. EFIC 2013 congress, taking place October 9-12, brings together over 4,000 pain specialists for a multidisciplinary forum focusing on chronic pain. - Health and Medicine Sun, 13 May 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,9/adid,3320/Itemid,26/ Overview: Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted. This presentation will discuss what advance preparation is needed on the part of the auditor, and discuss what the auditor should look for during the audit. Since documentation is often an issue, a discussion of documentation problems will be presented. Areas Covered in the Session: GMP regulations that apply to analytical laboratories. Reviewing documentation Advance preparation for the audit Auditing styles and structures Equipment and laboratory instrument qualification. What to look for while doing a walk-through. Other regulations and standards, including ISO 17025 Following through on the audit Who Will Benefit:This webinar will be of benefit to company auditors who need to investigate the qualifications of contract testing laboratories and internal testing facilities. It will also be beneficial to workers in laboratories that will be audited or inspected by external parties. Personnel from companies that perform testing on small molecule drugs, biologicals, and nutraceuticals will benefit from knowing what standards are being applied to them. The following specific types of workers will benefit from this webinar: External and Internal Auditors Supervisors and Analysts in Quality Control Laboratories and Quality Assurance groups. Supervisors and Analysts in Contract Testing Laboratories Personnel Responsible for Selecting Contract Testing Laboratories Consultants Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Phone: 800-447-9407 Fax: 302-288-6884 - Health and Medicine Fri, 11 May 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,9/adid,3319/Itemid,26/ Overview: The U.S. Food and Drug Administration issued the final rule establishing regulations to require current good manufacturing practices (CGMPs) for dietary supplements. The current good manufacturing practices (CGMPs) final rule will require that proper controls are in place for dietary supplements so that they are processed in a consistent manner, and meet quality standards. The CGMPs apply to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distributing them in the U.S. The rule establishes CGMPs for industry-wide use that are necessary to require that dietary supplements are manufactured consistently as to identity, purity, strength, and composition. The requirements include provisions related to: the design and construction of physical plants that facilitate maintenance, cleaning, proper manufacturing operations, quality control procedures, testing final product or incoming and inprocess materials, handling consumer complaints, and maintaining records. Dietary Supplement manufacturing sites have been increasingly inspected by the FDA for compliance with the GMPs, and warning letters have been issued. In the face of the increasing scrutiny by the FDA, it is incumbent on dietary supplement manufacturers to understand the regulations and to implement documentation and procedures that will ensure compliance. Why should you attend: The regulations require that you understand the requirements and establish a Quality System designed to meet them. This presentation will review the requirements and the rationale for them. Areas Covered in the Session: History of the regulations and their current status Review of the key points of the regulations Discussion of methods that can be used to comply with the regulations Documentation that is required for compliance The role of the Quality organization What to expect during an FDA inspection How to respond to an FDA inspection Raw material control and incoming inspection Cleaning and Maintenance Who Will Benefit: Senior Management Quality Control Management and personnel Manufacturing management and supervisors Warehouse Management and supervisors Shipping and Distribution Management and supervisors Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Phone: 800-447-9407 Fax: 302-288-6884 - Health and Medicine Fri, 11 May 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,9/adid,3318/Itemid,26/ Overview: This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and its compliance to the cGMPs. It will examine how these goals of the Agency have translated into action over the past two plus years: The changing focus of QSIT re: medical devices, and ICH Q8, Q9, and Q10 re: pharmaceuticals; Multi-site company operations, and the supply chain; Trends evident in 483 observations, Warning Letters, and recent major industry failures; Emphasis on proving a company is "in control" to an investigator's satisfaction; the negative role of "entropy", and proactive and reactive Warning Letter avoidance techniques. Why you should attend: The last few years have seen several major "names" in drugs and devices stumble over cGMP issues, resulting in recalls, lawsuits, and even possible criminal prosecution. As a result, there has been a major shift in the emphasis of the U.S. FDA cGMP compliance audit, also affecting clinical trial expectations, product submissions and company response requirements. This change in focus has a major impact on interpretation of individual compliance objectives, cGMP objectives, and measurements of success. Recent negative publicity on pharmaceuticals, devices, as well as events in unrelated industries has put pressure on the Agency to "get tough on compliance / enforcement". The public wants change. The U.S. FDA is responding. The cGMP compliance audit, validations, 510(k) submissions / data, "better science", lifecycles, closed-loop CAPA, outsourcing / globalization and supply chain / control issues, and senior management, are all under more intense scrutiny. Areas Covered In the Session: The Changed / Tougher FDA. Shifting and New Emphasis Core Expectations QSIT and Q10 Focus; and Q8 and Q9 "Lessons" High Risk Areas The Supply Chain The Multi-Site Challenge What Constitutes "Proof" Addressing the On-site Audit, the 483s, the Remediation / Responses Who will benefit: Senior Management in Drugs, Devices, Biologics, Dietary Supplements QA RA R&D Engineering Production Operations Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Phone: 800-447-9407 Fax: 302-288-6884 - Health and Medicine Fri, 11 May 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,9/adid,3317/Itemid,26/ Overview: This webinar is not a project management certification course. It is designed to provide the tools necessary to assist those designing a result or deliverable to achieve that end. It will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale. Three of the most common tools will be discussed. Common variants such as "dashboards" will also be presented. A very simple approach using common Excel- or Word-type PC applications programs that can be used immediately will be highlighted. Regular use of a few simple but powerful tools will virtually eliminate "fire fighting" in a new project. Regular use can contribute greatly to reduction of scheduling uncertainty, incomplete projects when time is running out, increased product liability, assist in company-wide cost reduction efforts, with less chance of recalls, and an improved bottom line. Why you should attend: The FDA expects companies to manage projects formally - to include regulatory requirements, design and/or change control, with consideration of all applicable standards. The EU MDD and their notified bodies are no different. How can this be done from a project's inception? How can a Project Leader or Project Manager ensure critical elements are not omitted until late in the project when disaster looms? How to minimize scope creep? What are the "lean" and "Agile" benefits and shortcomings in the cGMP environment? What is "failing fast" in the "build-measure-learn, re-evaluate / decide loop? How to gain management support for the Milestones, Tasks, and Timelines? Use the Plan as a powerful tool with FDA auditors. Use variations on these tools for any project, from the smallest to major company projects. These techniques are not rocket-science, but require the implementation of formal methods with documented and defensible rationale. Use these tools to bring predictability to your company's product development process. Use them to defend your remediation efforts with the FDA. Use them to prove "progress against plan". Areas Covered In the Session: Formal Project Management to Fulfill Common cGMP Requirements "Failing Fast" Lean Project Management The Three Most Common PM Tools -- Gantt, CPM, PERT + others Work breakdown Structure, Milestones, Tasks Drive Success for Failure Fast The Build, Measure, Learn, Re-evaluate Loop A Template / Example One Major, But Often Neglected, Use Who will benefit: Senior Management in Drugs, Devices, Biologics, Dietary Supplements QA RA R&D Engineering Production Operations Consultants; others tasked with project leadership responsibilities Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Phone: 800-447-9407 Fax: 302-288-6884 1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801 - Health and Medicine Fri, 11 May 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,9/adid,3316/Itemid,26/ Overview: To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field. It is critical that the company take the required steps in the required timeframes. FDA and ISO requirements overlap to a great extent, but not completely. This webinar sets forth the requirements for recalls, removals, and market corrections, and provides recommended practices. Why should you attend: There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field. It is critical that the company take the required steps in the required timeframes. If not, FDA's sanctions could be so onerous as to result in the company's inability to ship product. Areas Covered in the Session: Regulatory definitions of recalls, removals, and market corrections Instances which require recalls, removals, or market corrections What to do during recalls, removals, and market corrections Recordkeeping requirements for recalls, removals, and market corrections ISO 13485-specific requirements CMD-specific requirements (Canadian device regulations) Who Will Benefit: This webinar will provide valuable assistance to all regulated companies, since personnel training is a regulatory requirement in the Medical Device field. The employees who will benefit include: Regulatory Management Quality Assurance Professionals Consultants Sales/Marketing Management Senior and mid-level Management Quality System Auditors Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Phone: 800-447-9407 Fax: 302-288-6884 - Health and Medicine Fri, 11 May 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,9/adid,3315/Itemid,26/ Overview: The top management of a company is responsible for ensuring that all regulatory requirements are met. This concept is codified in both the QSR and ISO 13485. FDA officials have repeatedly stated that the management controls subsystem is the central subsystem because it is the "glue that holds the quality system together." Since it is individuals in top management that the FDA will typically seek to fine or prosecute in the event of major noncompliance, this session is key for those individuals who are members of top management, or those regulatory professionals who need to understand these requirements to assure top management is fulfilling its responsibilities. This session will discuss the requirements for Management Controls, including organizational structure, internal audits, establishment of a quality policy and confirmation it is being followed, establishment and contents of a quality system and quality plan, and of course all aspects of management reviews. Areas Covered In the Seminar: QSR and ISO 13485 requirements for management controls Organizational structure Establishment of an internal audit program Establishment of your company's quality policy Contents of your company's quality plan How/when to conduct management reviews Who will benefit: Regulatory Management Quality Assurance Professionals Consultants Sales/Marketing Management Senior and mid-level Management Quality System Auditors Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Phone: 800-447-9407 Fax: 302-288-6884 - Health and Medicine Fri, 11 May 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,9/adid,3314/Itemid,26/ Overview: This CAPA training program helps you to understand, in 10 easy steps, the entire CAPA process. It includes elements of Quality Tools, Team Effectiveness, Awards & Recognitions, and Verification & Validation of actions taken. Attend this webinar to grasp the A to Z of CAPA and learn how to implement & manage it for success. Why Should You Attend: We have found out, through auditing many organizations world-wide that the organizations are pretty good when it comes to corrective actions yet they are not nearly as good when it comes to the preventive actions. This webinar should provide you with enough ideas, suggestions and HOW TOs that you and your teams and organization overall get much better on the preventive actions and even better on the corrective actions. Includes all elements of CAPA process step as required by ISO and regulatory agencies. In addition, it is represented in a practical and proven manner which can be immediately applied in your organization. Areas Covered in the Seminar: Module 1 Introduction and Overview Correction vs. Corrective Action Understanding of all elements of CAPA process step as required by ISO and regulatory agencies Introduction to CAPA elements in a practical and proven manner which can be immediately applied in your organization Supporting stories and practical examples of CAPA - when each is appropriate and when one or the other is not appropriate The regulations and international requirements for CAPA and the clear understanding how to suit your procedures, work instructions and forms to address it Module 2 Examples of problem solving tools, management tools and measurement tools, which are great for identification of the true root cause(s) of the issue These tools also used for corrective actions, for most optimal definition of the improvement, for preventive actions Visual representation of the tools and examples where and when to use them Importance of proper assignment of a CAPA Examples are provided when it might be a good thing to assign a CAPA to a team Examples when would be a good thing to assign a CAPA to an individual Examples and definitions of teams and team members roles and responsibilities It can be used and applied in other areas inside and/or outside the organization when and where team work is required and expected This section by itself can be taken out and applied to other processes and practices within or outside of the organization with the goal of continuous improvement Module 3 Emphasize the importance and need of completing the verifications and/or validations of the actions taken to ensure that the issue has been resolved and the true root cause of the issue has been removed Real-life examples and suggestions which can be used immediately after completing the webinar Module 4 Examples how to appropriately award and recognize teams and individuals for producing the results Additional references and pointers where more successful examples and instructions can be found so that you and your organization can benefit and profit more from the CAPA process and CAPA teams - and maybe more importantly have those outside the quality department more engaged and interested in participating in CAPA and continuous improvements Q & A Who Will Benefit: Quality Managers Quality Engineers Small business owners CAPA investigators Inspectors Six Sigma specialists Consultants Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Phone: 800-447-9407 Fax: 302-288-6884 - Health and Medicine Fri, 11 May 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,9/adid,3313/Itemid,26/ Overview: A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process. Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820.30 Design Controls. FDA provides guidance and this course will address key resources when making critical decisions. Objectives: Know the differences between the Traditional, Special and Abbreviated submissions Understand Substantial Equivalence and how it is applied Who is required to submit the application to FDA Where to submit the 510(k) and what to expect with the review and approval process When it is and is not required if you are a device company Exemptions to the submission process and special considerations How to locate a "predicate" device and go through the content and format of the 510(k) Understand the De Novo process and the expectations for possibly marketing a low risk device Understand the potential impact of FDA's proposed changes to the 510(k) process and why manufacturers need to pay attention Detailed Agenda: Introduction and Regulatory Background There is no 510(k) form; however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission. Current trends with the 510(k) process. The Process Who is Required to Submit a 510(k) When a 510(k) is Not Required When a 510(k) is Required Locating and justifying the Predicate Substantial Equivalence and demonstration of SE to another legally U.S. marketed device How to Prepare Submissions 510(k) Submission Methods List of forms associated with Premarket Notification 510(k) submissions Deciding When to Submit a 510(k) for a Change to an Existing Device What happens if FDA requires additional information and data and your responsibilities Interactive Q&A, Wrap-Up and Adjourn Q&A with all attendees Group discussion and review of recent 510(k) clearances and proposals and recommendations between FDA and industry Discussion Points: some of the recommendations have included, but not limited to, redefining fundamental terms, limiting use of predicates, greater authority to rescind 510(k)s, etc. 510(k) Frequently Asked Questions Attendees should be prepared to address any issues and challenges as experienced on behalf of their company in this open-forum and interactive session Who will benefit: This course is appropriate to those involved in all aspects of the premarket notification, i.e., 510(k) process on behalf of medical device and In Vitro Diagnostic manufacturers. It is both a primer for personnel new to the FDA 510(k) process, or an excellent refresher course for those who need to revisit the basics and fundamentals for a better understanding on how to prepare and submit your application to ensure regulatory and compliance success. Those who will benefit includs: R&D Quality Assurance Quality Control Production Operations Engineering Compliance and Regulatory Affairs All Levels of Management, including technical and laboratory personnel who desire to understand what it takes to prepare and submit a bulletproof 510(k) to FDA while at the same time are aware of the changing regulatory landscape regarding FDA's proposed changes to the 510(k) process. Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Phone: 800-447-9407 Fax: 302-288-6884 - Health and Medicine Fri, 11 May 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,9/adid,3312/Itemid,26/ Overview: A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process. Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820.30 Design Controls. FDA provides guidance and this course will address key resources when making critical decisions. Objectives: Know the differences between the Traditional, Special and Abbreviated submissions Understand Substantial Equivalence and how it is applied Who is required to submit the application to FDA Where to submit the 510(k) and what to expect with the review and approval process When it is and is not required if you are a device company Exemptions to the submission process and special considerations How to locate a "predicate" device and go through the content and format of the 510(k) Understand the De Novo process and the expectations for possibly marketing a low risk device Understand the potential impact of FDA's proposed changes to the 510(k) process and why manufacturers need to pay attention Detailed Agenda: Introduction and Regulatory Background There is no 510(k) form; however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission. Current trends with the 510(k) process. The Process Who is Required to Submit a 510(k) When a 510(k) is Not Required When a 510(k) is Required Locating and justifying the Predicate Substantial Equivalence and demonstration of SE to another legally U.S. marketed device How to Prepare Submissions 510(k) Submission Methods List of forms associated with Premarket Notification 510(k) submissions Deciding When to Submit a 510(k) for a Change to an Existing Device What happens if FDA requires additional information and data and your responsibilities Interactive Q&A, Wrap-Up and Adjourn Q&A with all attendees Group discussion and review of recent 510(k) clearances and proposals and recommendations between FDA and industry Discussion Points: some of the recommendations have included, but not limited to, redefining fundamental terms, limiting use of predicates, greater authority to rescind 510(k)s, etc. 510(k) Frequently Asked Questions Attendees should be prepared to address any issues and challenges as experienced on behalf of their company in this open-forum and interactive session Who will benefit: This course is appropriate to those involved in all aspects of the premarket notification, i.e., 510(k) process on behalf of medical device and In Vitro Diagnostic manufacturers. It is both a primer for personnel new to the FDA 510(k) process, or an excellent refresher course for those who need to revisit the basics and fundamentals for a better understanding on how to prepare and submit your application to ensure regulatory and compliance success. Those who will benefit includs: R&D Quality Assurance Quality Control Production Operations Engineering Compliance and Regulatory Affairs All Levels of Management, including technical and laboratory personnel who desire to understand what it takes to prepare and submit a bulletproof 510(k) to FDA while at the same time are aware of the changing regulatory landscape regarding FDA's proposed changes to the 510(k) process. Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Phone: 800-447-9407 Fax: 302-288-6884 - Health and Medicine Fri, 11 May 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,9/adid,3311/Itemid,26/ Overview: Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 5) came into force on January 1, 2008. Providing more guidance than the previous version, the new document includes new reporting terminology and concepts such as "periodic summary reporting" and "trend reporting." In addition, the terms "advisory notice," "near incident," and "recall" have been eliminated or replaced. Although MEDDEVs are not legally binding, it is likely that all European Competent Authorities will follow the new guidelines and will expect organizations involved in the management and reporting of adverse incidents to follow them as well. This session will address topics such as new definitions; the guideline's extended scope, reporting criteria/timelines, filing safety notices and field safety corrective actions, and more. The new guidelines contain some controversial aspects, including the extension of their scope and the new approach of immediate reporting unless delays can be justified. However, they also provide additional clarity and more-detailed advice in many areas. The European Database EUDAMED also is described. Periodic or trend reporting under certain conditions is now allowed, as a result of the integration of certain GHTF concepts. Although a transition period was allowed until the end of 2007, the revised guidelines will undoubtedly result in the need for manufacturers, authorized representatives, and distributors to make changes to their SOPs and other documents. Areas Covered in the Session: Examine the latest changes to MEDDEV and Medical Device Vigilance and impact on medical device manufacturers Recognize the "new" terminology and concepts Report incidents as recommended by the guidance Examine why Global Harmonization Task Force (GHTF) is an integral component of the new postmarketing vigilance guidelines Manage expectations for reporting and timelines Recognize which amendments impact the European vigilance system Interpret the new guidelines that cover incidents involving devices that carry the CE mark and devices that do not carry the CE mark Submit periodic summary reports of incidents to Competent Authorities Examine controversial aspects of the guidelines, including the extension of their scope and the new approach of immediate reporting unless delays can be justified Identify the conditions under which reporting is not required and why they have been expanded and clarified with no significant changes, although one reason has been removed Who Will Benefit: This webinar will provide valuable assistance and guidance to device companies in involved in vigilance reporting. Employees who will benefit include: All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview Regulatory Affairs Clinical Affairs Quality and Compliance Marketing & Sales Distributors Engineering/Technical Services/Operations Consultants Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Phone: 800-447-9407 Fax: 302-288-6884 1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801 - Health and Medicine Fri, 11 May 2012 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,9/adid,3310/Itemid,26/ Overview: Lyophilization cycle scale-up and cycle transfer between dryers has traditionally been one of the most challenging issues in manufacturing. Cycles that have been designed on development-scale equipment, and are producing acceptable product, can suddenly start suffering from both physical and chemical instability when scaled-up to a larger freeze-dryer, or transferred between production freeze-dryers. Without understanding the scientific principles behind scale-up and cycle transfer, many companies will try tweaking the cycle parameters when problems are encountered during scale-up. While this approach may work occasionally, often, it will lead to additional problems such as excessively long cycle times, shattered vials, higher residual moisture content, etc. Taking the time to design and execute a well thought out scale up study, will ensure that cycles and products will transfer seamlessly from dryer to dryer without costly time delays and product rejection. One issue in particular that has been observed during scale-up, is loss of vacuum control within the product chamber of the freeze-dryer. Common sense would dictate a vacuum pump failure or a vaccumleak as the source of failure; however, the phenomenon known as, "choked flow", is something completely unrelated to vacuum pumps and vacuum leaks. Being able to identify the difference between vacuum system issues and choked flow makes correcting the problem much easier, saving both time and money in diagnosing and correcting the problem. Why you should attend: Many problems have arisen in the past when designing and scaling-up lyophilization cycles because this process was more of an art than a science, and cycles were designed and scaled-up based on a "trial and error" approach. Companies that do not understand the scientific principles behind their cycles run the risk of being delayed in getting their products approved and on the market, which can have a dramatic impact on their profit margin. By far, one of the most difficult tasks in getting a lyophilized product from the laboratory bench to the commercial freeze-dryer is scale-up, or cycle transfer. Problems that typically arise from scale up issues include shattered vials, meltback, collapse, higher residual moisture levels, and decreased shelf life. By taking the time to identify the critical issues for a particular product and understanding equipment differences, the development scientist or engineer has a much higher chance of successfully producing consistent, quality, product whether it is being dried in a development-scale dryer, a clinical-scale dryer, or a large commercial-scale dryer. Finally, time will be dedicated to discussing the phenomenon known as sonic water vapor flow or, "choked flow" in a freeze-dryer. This is a problem that typically manifests itself when scaling-up a lyophilization cycle or transferring that cycle to another freeze-dryer, and is characterized by a loss of control over the vacuum in the sample chamber. As chamber pressure rises in the sample chamber, product temperature rises as well, often resulting in product loss. This webinar will cover the reasons for choked flow, how to recognize choked flow is occurring, and how to prevent this from happening in future cycles. Areas Covered in the Session: Critical parameters in scale-up and cycle transfer Scale-up strategy Mapping studies Dryer configuration Determining and preventing choked flow conditions Learning objectives: Understanding the differences between development, pilot, and productions dryers Proper information gathering (IO, OQ, manufacturer specifications, operator knowledge, etc.) Design and execution of a well thought out scale up strategy Identifying choked flow conditions, and designing a cycle to prevent choked flow from occurring Who Will Benefit: This webinar will provide valuable assistance to those companies involved in the development and scale-up of therapeutic and diagnostic lyophilized products. Quality Control Scientists Development Scientists Production Management Quality Assurance Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Phone: 800-447-9407 Fax: 302-288-6884 - Health and Medicine Fri, 11 May 2012 00:00:00 +0100