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 designed to provide…

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 designed to provide…

This webinar will teach you a methodology to perform experiments in an optimal fashion and review the common types of experimental designs and techniques. You will learn to develop predictive models to describe the effects that variables have on one or more responses and utilize predictive models to develop optimal solutions. Why Should You Attend: Experimentation is frequently performed using trial and error approaches which are extremely inefficient and rarely lead to optimal solutions. Furthermore, when it’s desired to understand the effect of multiple variables on an outcome (response), “one-factor-at-a-time” trials are often performed. Not only is this approach inefficient,…

This webinar will show how you can use failure data to predict expected future failures, proactively drive quality and reliability improvement and react quickly to emerging issues. Why Should You Attend: Manufacturers design and develop products based on an expected product lifetime. Many manufacturers conduct extensive reliability testing to minimize the risk that products will fail prematurely. Despite these efforts, unexpected failures occur due to design flaws, manufacturing process changes, or a misunderstanding of the product use environment. Premature failures alienate customers and significantly impair brand and company reputations. Failure data may be easily modeled to forecast future failures and…

This OSHA inspection webinar will cover aspects of an OSHA inspection from how establishments are targeted, how to limit the scope of an inspection or investigation, how not to self-incriminate, and when and how to appeal. Why Should You Attend: An OSHA inspection can be a costly and disruptive experience for any employer, especially if that employer has not dealt with the Agency, does not have an in-house safety professional or attorney. An OSHA inspection that goes badly essentially says the employer has a defective safety program, is not sufficiently focused on the safety and health of its employees, or…

This 90-minute OSHA Recordkeeping training class will incorporate the lessons learned from OSHA’s recent Interpretation Letters into the existing OSHA recordkeeping analysis as well as OSHA’s current Frequently Asked Questions. In this interactive program, OSHA recordkeeping scenarios will be used so that the rules articulated in the recent Interpretation Letters can be applied to real-life factual situations that arise in your work environments. Why Should You Attend: OSHA injury and illness recordkeeping compliance is a point of emphasis for OSHA, and the recordkeeping regulations are frequently cited by the Agency. In addition to providing instruction on how to apply the…

This Method Validation training in drug development process will provide guidance in setting appropriate specifications, determining if the assay is validatable, and monitoring progress during the validation. Why Should You Attend: This webinar will address frequently observed issues and problems with method validations. Validated methods are required for Phase III of the drug development process. Moving methods from the development phase to the validated phase ready for sample analysis does not always occur without unforeseen issues arising. Differences in laboratories and analysts, as well as instrumentation can contribute to delays in validating methods. Setting appropriate specifications and criteria based on…

This Sterility or Bioburden test Webinar/training will discuss on various items that should be investigated to determine the root cause and the follow up to the investigation. Why Should You Attend: All sterile products require some level of sterility and bioburden testing during validation and then during routine production. What actions your company takes when this testing exhibits results that do not meet specifications can be critical from a regulatory and safety standpoint. You need to know what and how to investigate during these potential failures or out-of-specification conditions to identify the root cause. You also need to know if…

This 90-minute webinar on medical device quality assurance practices will review robust quality assurance principles and teach you techniques and lean methods to help you implement FDA Quality System Requirements. Why Should You Attend: Quality assurance work force is considered as the bearer of bad news. It should be the bearers of good news. They can anticipate adverse events and near misses before they happen and prevent them from happening. This seminar emphasizes elegant solutions to quality improvements resulting in high return on investment. This is one of the good news management is looking forward to. Then your organization can…

This 90-minute webinar will help you understand the 510K process including some history about 510ks versus PMAs and give you the necessary information to know when to file a 510k, as opposed to a PMA, or to not file any 510K of a new or existing medical device. Why Should You Attend: FDA is responsible for overseeing entry into the market of all medical devices. All devices, unless exempt, must go through a pre-market review for safety and efficacy. Anyone who wants to be a player in the medical device market must have a sound understanding of what is expected…

This 3-hr virtual seminar will discuss the requirements and compliance in medical device adverse event reporting and medical device surveillance/vigilance system in the US, Europe and Canada. It is designed to help the audience with their global compliance in adverse event reporting and surveillance/vigilance system during pre- and post-marketing. Why Should You Attend: To be able to achieve sustainability and to remain sustainable and competitive in global medical device markets, it is necessary to streamline regulatory compliance processes, in particular, the Adverse Event (AE) Reporting during clinical studies and post-marketing. Thus, to establish and maintain a medical device AE reporting…

This 90-minute webinar on Advanced Methods of Root Causes Analysis, for medical device companies, will cover principles and methods of Root Cause Analysis (RCA) and review proven techniques for ISO 14971 Risk Reduction based on RCA. Why Should You Attend: Root Cause Analysis (RCA) is the most important tool in device recall investigations and for preventing the adverse events. Unfortunately there is substantial misunderstanding of the limitations of the tool and how to use it correctly. The result is often wrong judgments, wrong design changes, and wasted efforts. Doing it right will reduce costs. Using advanced methods will make a…

This 90-minute webinar will help you establish an effective Good Clinical Practice (GCP) by providing a current, accurate and complete (CAC) review and understanding of the relevant and applicable regulations for clinical trials or studies, the requirements and compliance in a systematic, integrative (SI) manner. Why Should You Attend: To be able to achieve sustainability and to remain sustainable and competitive in global medical product markets, it is necessary to streamline regulatory compliance processes, in particular, the Good Clinical Practice (GCP) for clinical trials and studies and beyond. To establish and maintain GCP, it is critical to accurately define, document…

This webinar on clinical site audit/ inspection will outline the responsibilities of the Investigator and the clinical research coordinator during and after site audits/inspections and show what you must do to ensure preparedness at all times. Why Should You Attend: The Clinical Research Coordinator (CRC) plays a key role in the site’s success at audits/inspections, and must therefore know how to ensure the site is ready for an audit or inspection at all times. In order to ensure audit/inspection preparedness, the CRC must be aware of the applicable regulatory and sponsor requirements, guidelines and SOPs, and ensure the conduct of…

This 90-minute webinar will help you identify the challenges in Phase I and FIM studies and present solutions on how to overcome these challenges. Why Should You Attend: As need for more aggressive drug development that still ensures the safety of the subjects and the drug itself becomes more and more important, the challenges of those individuals responsible for the Phase I activities increase exponentially. To not meet these challenges has consequences. The lines of distinction between the classical phases in the drug development are becoming more and more blurred, and the challenges facing the Sponsor, the Principal Investigator, and…

This 90-minute webinar will provide an overview of regulatory management for clinical trials. It will discuss key regulatory aspects of a clinical project such as clinical protocol management, IRB management, safety reporting, rules for recruitment programs, seeking advice from FDA, trial master files, and training requirements. Why Should You Attend: Clinical Project Managers need to have clear perspective of what may be needed for assuring compliance with FDA requirements of a given clinical trial at all times. Non-compliance with these requirements could lead to rejection of the trial data, and even other more severe penalties. This course will provide an…

This 90-minute webinar will cover the basic principles of pharmacogenomics and pharmacogenetics and will discuss in detail the steps behind implementing a clinical pharmacotenomic testing service. Why Should You Attend: The FDA's Center for Drug Education and Research has relabeled many drugs recommending pharmacogenomic testing. In other cases, the FDA has issued "black box" warnings cautioning doctors that there are genetic variances that effect safety profile for drugs such as codeine and clopidogrel. These FDA mandates have driven the adoption of pharmacogenomic testing into clinical practice to date. Pharmacogenomic laboratory tests are available for these drugs.Adverse events caused by these…

This training on hiring and managing CROs or AROs will show how you can ensure that you choose the right CRO/ARO based on the phase of the trial, the therapeutic area and the countries that the trials will be conducted. Why Should You Attend: A critical component in successful Clinical Research Trials is ensuring that you choose the right CRO/AOR based on the phase of the trial, the therapeutic area and the countries that the trials will be conducted. It is then important that the scope of the work be clearly defined to ensure that budget and timelines are respected…

It is our pleasure to announce that the 3rd International Conference on Environmental Aspects of Bangladesh (ICEAB12), is going to be held on 13~14 Oct. 2012, in the University of Kitakyushu, Japan, by Bangladesh Environment Network Japan (BENJapan). The ICEAB12 provides vibrant opportunities for researchers, industry practitioners, students & fellow citizens to share their researches, ideas, & review various environmental aspects of Bangladesh, Japan and other regions of the globe. We are hopeful that researchers around the world who are working on various environmental & related issues will gather and share their works, views and move forward to work together…

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…