This webinar will explain the FDA QSR requirements for acceptance activities related to medical device manufacturing. It clarifies FDA’s intent using the preamble to the regulations. We will analyze recent Warning Letters and provide tips to ensure that your acceptance activities fully complies with the regulatory requirements. Why Should You Attend: Acceptance activities are common in device manufacturing, but seem to cause problems for some manufacturers. These problems range from simple instances of lack of procedures or acceptance criteria to misapplication of statistical methods. Your Quality Management System (QMS) should be able to address these questions quickly and easily. If…

This webinar on pharmaceutical water systems will explain practical best practices for outlet use and sampling to reflect the true water quality and how to most effectively use the resulting data to improve manufacturing’s water use practices and maintain water system control before problems arise from biofilm-related contamination. Why Should You Attend: Problematic removal of pristine water from a pharmaceutical or other high purity water system, for use in manufacturing, cleaning or for sampling, is likely responsible for as much as 90% of all water system deviations. Done properly, it can lead to greatly reduced product or process contamination, improved…

This webinar will cover the regulatory requirements, challenges and opportunities in extending clinical trials to European Union countries by a virtual pharmaceutical or biotech company. Why Should You Attend: There are unique challenges and opportunities in conducting clinical studies in (or extending existing ones to) the EU by a virtual pharmaceutical or biotech company. The challenges are in understanding the mechanism and process of application both centrally and in each individual state and the steps necessary to recruit sites and commence enrollment. In addition, there are unique challenges in monitoring these studies and maintaining regulatory compliance during their conduct phase.…

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 3-hr virtual seminar will provide an introduction to FDA’s Regulation of Medical Devices and is intended for the Beginner. It will cover device classification, the device manufacturer’s and/or distributor’s regulatory responsibilities, requirements for labeling and user fees, fda inspections and enforcement. Why Should You Attend: This webinar is intended to provide the Beginner with an introduction to the U.S. Food and Drug Administration’s regulation of medical devices. This introductory course will present the beginner with an introduction to FDA and its regulatory authority as it relates to medical devices. The presenter will discuss FDA’s medical device classification system and…

China’s Premier R&D Summit Just Got Bigger! --- NEW! Revamped Programme featuring GLOBAL Keynote Presentations --- TOP Chinese and Asian Pharma on their role in Global R&D --- INNOVATION SPOTLIGHT: Vote for China R&D’s own ‘Pharma Idol’ --- BIG PICTURE In-Depth CxO Panel Debates on Innovation, Collaboration, Co-Development --- UNIQUE & never heard before insights from the DISCUSSION DEN --- THOUGHTLEADER Roundtables on Clinical Development, Regulatory, Biopharma R&D --- MORE – Over 60 Speakers, 30+ expert speaker sessions, case studies --- EXPANDED SHOWCASE Exhibits including the event’s very own • CRO CLINIC • Onsite Lab & • China Pavilion ---…

IBC’s 4 th Vaccines China 2012 is timely and has been researched with the industry to provide the most comprehensive event focused on vaccines development through to manufacturing. Good manufacturing practices and strategies will be reviewed, alongside potential block-buster technologies and R&D projects. This conference is co-located with the 7 th annual China Pharmaceutical R&D Summit and 3 rd annual Biosimilars Asia conference to maximize cross-learning, partnering and networking opportunities with biopharma and related industries. 5 top reasons to attend 1.Gain insights into quality and compliance strategies by international and local vaccines manufacturers. 2.Identify prospective research projects and technologies for…

IBC’s 3rd Annual Biosimilars Asia 2012 is the largest and most anticipated meeting of its kind in Asia. Attended by biosimilars, innovators, generics and biopharma alike, the unique mix of attendees from all over the world will share their experiences and opinions about the future of biosimilars. Tough questions will be answered and positions will be challenged but all will walk away bristling with ideas, opportunities and be more informed. Biosimilars Asia 2012 continues to deliver a quality of speakers and discussions unmatched in Asia. REASONS WHY BIOSIMILARS ASIA IS A ‘MUST ATTEND’ •Biosimilars Asia 2012 is Asia’s LARGEST CONFERENCE…

This 90-minute webinar on Lean Project Management for U.S. FDA Regulated companies will show how you can incorporate basic lean principles for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale, while addressing FDA / CGMP requirements. Description Both the FDA and the EU MDD expect companies to manage projects formally -- to include regulatory requirements, design and/or change control, with consideration of all applicable standards, and to demonstrate "progress against plan". This webinar will provide valuable guidance to regulated companies in development and implementation of new Lean Project…

The 2nd Annual BDT2012, presented by Event Protocol, brings together leaders from the diagnostic, pharmaceutical, medical and academic fields to evaluate developments in biomarker research and development. Areas of focus include companion diagnostics, clinical drug development and personalized treatment options. Key hurdles in biomarker identification and validation will be discussed, and new technological solutions, research targets and discovery strategies aiding in the translation of biomarkers to the clinic will be critically examined. Early bird rates available when you register before 1st March 2012!

This 2-hr webinar on DEA Due Diligence will cover several recommendations to improve the Corporate Due Diligence when controlled substances and regulated chemicals are purchased by their customers and the steps that can be taken to detect and prevent the illicit use or diversion of any narcotic drug sold to customers. Description Understanding the DEA "Know Your Customer Policy" is important and the steps suggested in this training will give you a better insight as to what steps should be taken to prevent the illicit use or diversion of any controlled substance and regulated chemical products purchased by a customer.…

This webinar on product complaint investigations will provide the necessary information to those in food, drug, device, cosmetic and related industries that manufacture and distribute products to consumers on how to best receive, respond, investigate and correct product complaints in the best interests of the firm. Why Should You Attend: Every firm that manufactures FDA regulated products sold to consumers will at some time receive product complaints. What can happen when product complaints are ignored? How the firm responds to and handles the complaints is incredibly important both to the good will of the firm in the marketplace and to…

This 120-minute webinar will cover the new (Federal) Physician Payment Sunshine Act, the topics raised by the proposed rule and existing State sunshine laws. Attendees will learn about reporting, certification and registration deadlines and what specifically needs to be reported or provided to the relevant authority. Description New federal legislation governs relationships between physicians and medical device, drug and biotech manufacturers. The Physician Payment Sunshine Act requires detailed reporting in 2013 of "transfers of value" made in 2012 to physicians and teaching hospitals. The information reported will be made public by CMS. Are you prepared to track and report gifts…

This webinar will help you understand the current requirements for raw material management with tips about practical implementation. It covers FDA’s expectations from GMP facilities regarding raw material vendor selection, measures for assuring acceptable quality of material supplied, expectations from quality control and documentation processes, and training requirements, with case studies. Description Almost all FDA findings during GMP inspections include raw material related issues and most FDA warning letters to GMP facilities cite violations in raw material management. FDA's GMP inspectors pay special attention to the way raw materials are sourced, handled, controlled, used, and accounted for at a given…

Bright International Conferences & Events gather up all the participants to attend the World Congress on Biotechnology which will be held during 4-6 May 2012 Hyderabad, India. The Bright ICE provides vibrant opportunities for research scientists, industry practitioners, students to share their research experience, ideas, review of various aspects in Biotechnology, Informatics and related fields. The Bright ICE paves a way to gather visionaries through the research talks and presentations and put forward many thought-provoking strategies in Biotechnology & its related fields. The Bright ICE will open doors for challenging research areas for future through panel discussions and special talks.…

The World Council of Fisheries Societies is a non-profit, nongovernmental organisation that currently includes 12 scientific and professional fisheries societies and affiliated organisations world wide. The main aim of the Council is to promote international cooperation in fisheries science, conservation and management by encouraging and promoting sustainable management practices, excellence in fisheries research and the wise use of fishery resources. One important way in which the Council seeks to achieve these ends is through the organisation of a major World Fisheries Congress every 4 years. The Congress has hosted 5 highly successful meetings, the most recent being the 5th in…

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…

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 webinar explains concepts required for a calibration program that satisfies FDA’s Quality System Regulation (QSR), ISO 13485, and ISO 9001. It defines the concepts of accuracy and precision that define the measuring equipment’s requirements. It also explains the meaning of traceability Why Should You Attend: Managing your calibration program is a key element in delivering good products and services. You must satisfy the QMS requirements but first you need to understand them. You need to know when a piece of equipment needs to be in the calibration recall program and when you can identify it as “no calibration required”.…

This 90-minute training on statistics used in pharmaceutical quality control will cover statistical interpretation related to quality control test results and process indicators in the pharmaceutical industry. Why Should You Attend:- Quality control tests in pharmaceutical industry carries a burden on its own, as these tests are usually complicated, time consuming and expensive, and in many cases wrong interpretation of test results lead to disastrous situations. Any QC test is not considered successful until the resulting data are analyzed statistically and are complied within specifications limits. Wrong interpretation of the tests results can cost the company since it can end…