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…

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 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…

This webinar on IND and IDE Application management will help you understand the current FDA requirements for IND and IDE application post initial approval to proceed with the clinical trial. Why Should You Attend:- If your company has active IND or IDE applications with the FDA or are planning to file one soon, this seminar will help you understand the current FDA requirements for IND and IDE application post initial approval to proceed with the clinical trial. You can get valuable tips and training in less than an hour on practical methods for collecting required documents for submission to the…

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 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 webinar on lyophilization technology will provide you the understanding required to develop an optimized, cGMP compliant formulation that is specifically designed for lyophilization. Why Should You Attend:- The Food and Drug Administration (FDA) is becoming more and more educated in the practice and science of lyophilization. As such, they are asking more questions about lyophilization during NDA or ANDA document reviews, site visits to companies producing lyophilized products, etc. It is now expected by the FDA, that companies developing new formulations and lyophilization cycles must be able to explain, scientifically, why they have chosen each excipient they have added…

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…

The Biological Production Forum attracts senior level biopharmaceutical industry professionals working within manufacturing, process development and product operations. The global biological production industry is under pressure amidst challenging price restrictions, US health care reforms and reduced revenues. The agenda features a pharma QBD case study stream as well as keynote sessions, interactive workshops and networking activities. Some of the key topics to be discussed are: • Minimising Human Error To Optimise Manufacturing • Successfully Meeting Virus Safety Requirements • Designing A New Product Facility • Successfully Designing A Single Use Facility • Successfully Meeting Supply And Demand For Vaccine Production…

Implementing Effective Early Phase Trial Strategies in Asia to Reduce Approval Timelines, Risks and Costs from First-In-Human through Proof of Concept In March 2011, listings of clinical trials registered in the US FDA's clinical trial registration database showed that almost 15,680 trials are currently registered in Asia. Also we have seen a significant increase in the number of early-phase clinical trials conducted in Asia, including First-in-Human, Phase I and Phase II(a). What strategies are you putting in place to prevent early and late stage failures? 2nd Annual Early Phase Clinical Trials Asia 2012 is a high-level platform for pharmaceutical and…

At IBC's 4th Annual BioProcess International™ China event, the goal is to bring China and the rest of the world together to explore the missing gaps in China's development, and to help bring China up-to-speed on critical areas such as cell line engineering, media development, analytical characterization strategies to establish similarity between a biosimilar and its originator drug, as well as design of multi-product facilities and implementation of single-use systems. Bringing together global leaders to provide you with proven scientific and technical strategies and innovations on: •Cell Line Engineering, Cell Culture and Media Development •Analytical Characterization, Comparability and Quality Assessment…

This 90-minute training on the FDA system based inspection technique will focus on the responsibilities of the laboratory within the systems based inspection approach and will help the personnel in the quality control laboratory understand their role in the new FDA focus on Systems. Description FACT: Many organizations do not understand the FDA move to Systems Based Inspections. One of the focus areas for many inspections is the laboratory and it is important that laboratory personnel understand the FDA system based inspection technique and the type of things the FDA will look at when they decide to investigate the Laboratory…

This webinar will provide an expert overview of the newly evolving compliance requirements for import or export of fresh produce, frozen or other food from or to foreign countries. It will show how you can meet the new CBP, Food Safety Modernization Act and FDA rules before enactment of those rules is announced. Description If your company imports or exports fresh produce, frozen or other food from or to foreign countries, you need to be aware of newly evolving compliance requirements and you must be able to put in place a proactive strategy in order to assure and protect your…

This food safety audit webinar will provide a comparison of Third Party audit schemes (including certified and non-certified). The differences in criteria and attainment will be reviewed. Why Should You Attend: Customers such as Wal Mart and other retailers utilize Third Party Audits to assess the Quality Systems of their suppliers. But food safety certification is both costly and time consuming. In recent times, food manufacturers are seeing a substantial increase in the number of requests for audits which adds to the complexity of understanding which certification is good for your company. Attend this 90-minute webinar to get a comprehensive…

This Spreadsheet validation training explores strategies for recognizing when validation is required, how to achieve compliance and what documentation needs to be generated and maintained. Description Spreadsheets are powerful business tools, and are increasingly used in manufacturing, tracking and quality systems - as well as in generating and interpreting business data. FDA requires spreadsheets to be validated per 21 CFR 210-211, Part 820 and to be compliant to 21 CFR Part 11 in some cases. Areas Covered in the seminar: - Review of current FDA posture towards spreadsheets. - Review the relationship between "validation" and "part 11 compliance". - How…

This GAMP® 5 training/Webinar will discuss on the GAMP® software validation model and the defined process of GAMP® 5 as it applied to FDA software validation. Why Should You Attend: Many companies struggle with understanding what FDA, MHRA, EU and other Ministries of Health want to see regarding software validation.This presentation will review the FDA validation process, the GAMP® software validation model, and the process defined in GAMP® 5 as it applies to FDA software validation. The attendee should leave the presentation confident in their ability to understand and apply the GAMP® 5 process. - FDA inspectors are now being…

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 FDA software validation Webinar/training will discuss how to self audit and ensure validation and software quality processes that will pass FDA inspection. Why Should You Attend: FDA Commissioner Margaret Hamburg recently announced several new enforcement initiatives. They are certain to impact your regulatory risk profile. How will you prepare for software quality, software validation and 21 CFR part 11 planning? Pharma, Biotech and Medical Device manufacturers are self-regulated with FDA oversight. By the time FDA come to your door, it may be too late to bring order to chaos. Companies have the responsibility to self audit to ensure compliance…

BIT Congress is pleased to announce that the 2nd Annual Congress of Marine Biotechnology (WCMB-2012) will be held from September 20-23, 2012 in Dalian, China, with the theme "Ocean, Inspiration, and Innovations". On behalf of the organizing committee, I cordially invite you to attend this conference, and to come ready to discuss exciting new ideas and achievements in this field. On earth the oceans comprise the biggest part of the biosphere and also contain the most ancient and diverse forms of life. It is only with the tools of modern science that these biological resources can be studied in detail,…

Welcome to Dalian and BIT's 1st Annual World Congress of Mariculture and Fisheries with the theme "Treasure Seafood, Innovation and Sustainability" in September 20-23, 2012 The Conference aims at reviewing past and present performances in the sector for it to continue contributing to the national economy in an efficient, dynamic and modern manner. The conference will focus on issues relating to governance, sustainability, economics, management, legal framework and involvement of China in the fishery sector. International and local speakers will address issues facing the Chinese seafood industry, with special reference to fisheries management, resource status, policy, access requirements to major…