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 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 Disinfection and Cleanroom Cleaning training will teach you how to choose the best disinfectants, know the different performance parameters of disinfectants, methods to qualify disinfectants, writing and executing cleaning procedures. Areas Covered in the Seminar: * Disinfectants commonly used in the industry, their modes of action, efficacy, and toxicity. * Understanding the nature of contaminants in the cleanroom and which disinfectants will be effective against them. * Benefits and drawbacks for using each type of disinfectant used in the Pharmaceutical Industry. * Bodies that regulate disinfectant manufacturers and testing required by manufacturer’s for label claim. * Learn disinfectant testing…

Why Should You Attend: This presentation begins with an overview of the biological self versus non-self mechanism resulting in the anti-drug response of biopharmaceuticals. The next section describes how to differentiate the risk associated with internal attributes of the drug from the risk derived from external factors. That guideline in conjunction with the latest industry recommendations and regulatory guidelines provides a logical approach to the risk strategy. The second-half of the presentation demonstrates how to use pre-clinical results to further characterize (but not predict) the immunogenicity response and utilize this information to be ready for adverse effects during clinical trials.…

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 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 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 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 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 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…

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 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 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 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…

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…