This 90-minute webinar will provide guidelines for bioassay validation and regulatory documentation, the steps for technology transfer and commercial validation show how to implement the new USP chapters 1032, 1033 and 1034. Why Should You Attend: Potency bioassays are an integral part of release testing and stability studies for biotechnological products. There is a lack of clarity of how much work is required at each development phase to maintain scientific rigor and meet regulatory expectations. This webinar provides a logical plan to progress the potency bioassay from a tool to assist in pre-clinical process evaluation throughout final commercial implementation. The…

This OSHA Inspection and Accident Investigation training will provide practical tips for safety professionals and managers on what the OSHA inspectors will look for, how to respond to a letter of complaint, how employees and unions figure into the inspection equation, and what you must do to expedite the inspection and help resolve issues before they become major problems. Why Should You Attend: Perhaps of all of the interactions that occur with regulatory agencies, the unannounced OSHA inspection is the most stressful, and least understood by business owners. The key to managing a surprise OSHA Inspection or a letter of…

This contamination control webinar will discuss how personnel practices, transferring items into cleanrooms, facility design, construction, and sporicidal chemistries are critical and how it can be addressed in developing a successful contamination control program. Areas Covered in the Seminar: * Developing effective ways to address spore excursions. * Troubleshooting real world experiences. * Developing preventative action plans. * Learn ways to improve facility design and maintenance. * The most effective sporicidal chemistries will be discussed in detail. * Cleaning and Disinfection Methods will be addressed. * Warning Letters and 483’s from FDA will be discussed and addressed. Who Will Benefit:…

The US FDA has issued a draft guidance document outlining a suggested approach to complying with current good manufacturing practice (CGMP) requirements for drugs intended soley in Phase 1 studies.With this guidance and an accompanying regulation, US FDA formally recognizes specific standards for the manufacture of small amounts of drug products for phase 1 studies and formulating an approach to cGMP compliance that is appropriate for the particular stage of drug development. This presentation will give an insiders insight into the the new guidance and regulation and discuss the rationale for such. Areas Covered in the seminar: - Background and…

This 90-minute cleanroom contamination control training will review the common mistakes that people make in cleanrooms that lead to contamination, show how to develop a successful contamination control program and discuss ways to improve your facility's design and maintenance. Why Should You Attend: This 90-minute presentation will review the basics of personnel practices and discuss cleaning and disinfection. The most common source of contamination in the cleanroom are people and as such it is important to cover common mistakes in behavior and gowning. The speaker will address facility design and conditions as well since these are also a contributor to…

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…

This 3-hr virtual seminar - OSHA Asbestos and Mold Awareness - will cover OSHA's regulations on Asbestos and specific guidelines and general regulations on Mold. Why Should You Attend: Asbestos is one of the most highly regulated substances, and for good reasons as it’s a potent carcinogen with no known safe exposure. Of all of the toxic and hazardous substances it could have regulated, OSHA chose to regulate Asbestos first. Mold, on the other hand, is an even more ubiquitous contaminant in buildings, yet OSHA has not even attempted any regulations specific to it. Instead, they have a set of…

ICPDRE 2012 will be held during February 18-19, 2012 in Coimbatore, India. ICPDRE 2012, is to bring together innovative academics and industrial experts in the field of Product Development and Renewable Energy Resources to a common forum. The primary goal of the conference is to promote research and developmental activities in Product Development and Renewable Energy Resources. Another goal is to promote scientific information interchange between researchers, developers, engineers, students, and practitioners working in India and abroad. The conference will be held every year to make it an ideal platform for people to share views and experiences in Product Development…

CELL LINE DEVELOPMENT & ENGINEERING ASIA brings together experts and top scientists from biopharmas, biotechs, CMOs and research institutes as well as leading technology providers from Asia and globally. The region’s 1st and ONLY focused Cell Line Development and Engineering Asia provides a forum where industry experts share lessons learned through case studies, strategic discussion groups and interactive roundtables to collectively collaborate and provide solutions to your most pressing challenges. Bring back new ideas to do better business. Key themes and issues include: 1.Examining the Business and Regulatory Landscape 2.Cell Line Development Approaches for Biosimilars 3.Addressing Timeline Bottlenecks in Development…

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 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…

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 Bioassays webinar will systematically outline the steps needed to successfully transfer validated biological assays between GMP/GLP labs and also acquire non-validated assays for GMP/GLP development. Why Should You Attend: 50% of the drugs presently in discovery are biopharmaceuticals - these numbers lead to an "outsource or perish" philosophy for GMP/GLP development, validation and sample analysis. Unlike synthetic drugs requiring only straightforward analytical testing biopharmaceuticals require more elaborate assays to attain regulatory compliance. The industry has a significant underestimation of the discipline; skills and planning required to successfully transferring these assays. Naiveté in this area causes loss of precious time…

This webinar will cover the basics of design controls for medical devices, and provide recommendations for implementation of a compliant design control system. Also discussed will be design control requirements for devices already in distribution. Documentation requirements for each design stage will be included as well. Why You Should Attend: Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed. This process must ensure that all requirements are met. A firm's design control process must meet all regulatory requirements, but at the same time not be as unwieldy…

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…

The best forum to gain applied and basic knowledge, build your collaborative network, and learn skills to move your projects forward in one of today's hottest research areas AsiaTIDES continues to be the premier forum to get a comprehensive update, meet key players and increase your knowledge of the oligonucleotide- and peptide-based therapeutics fields. The faculty list for the 2012 program is the strongest yet, with more representation from big pharma than ever before. Hear new data and strategic perspectives from Merck, Genzyme, and GlaxoSmithKline, including three presentations from Glaxo on a peptide project and their assessments of both the…

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 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 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…