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  • 161 Request Info

    Statistics for Non-Statisticians Course | Biostatistics Boston 2018

    Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics. Many statistical softwares are now available to professionals. However, these softwares were developed for statisticians and can often be daunting to non-statisticians. How do you know if you are pressing the right key, let alone performing the best test? This seminar provides a non-mathematical introduction to biostatistics and is designed for non-statisticians. And it will benefit professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901561SEMINAR?trainingregistry-March-2018-SEO
  • 162 Request Info

    Drug Products for Clinical Trials | FDA Approved Drugs List 2018

    In January 2006, FDA issued a final rule which specified that most pharmaceutical products (including biologics) produced for use in Phase I clinical trial studies were exempted from complying with GMP requirements, as defined in 21 CFR Part 211 under 21 CFR 210.2(c). Section 501(a)(2)(B) of the FD&C Act requires drugs, including IND products, to comply with cGMPs or if they are not manufactured in compliance with cGMPs, they are deemed adulterated. Based on this statutory requirement for manufacturers to follow GMPs, FDA issued cGMP regulations for drug and biological products in the Code of Federal Regulations (in 21 CFR parts 210 and 211). Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901549SEMINAR?trainingregistry-March-2018-SEO
  • 163 Request Info

    What is 21 CFR Compliance | 21 CFR Part 11 Regulations 2018

    Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901540SEMINAR?trainingregistry-March-2018-SEO
  • 164 Request Info

    Human Factors Psychology Graduate Programs | Human Factors 2018

    The ISO 62366 is an "Consensus" Standard, making it a gold standard for regulatory submissions. We will look at other reference points regarding HF, like AAMI/ANSI HE75:2009 and how HF Engineering include consideration of: Device Users Use Environments and User Interfaces Preliminary Analyses Exploratory HF/Usability Evaluations Hazard Mitigation and Control We will look at the implication of HFE through Design Controls in the QSR: Design input -includes "needs of the user and patient" Design validation - "... devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901501SEMINAR?trainingregistry-February-2018-SEO
  • 165 Request Info

    Quality Management System Courses | Quality Professionals 2018

    Many companies struggle to establish and maintain a Quality Management System (QMS) that is both efficient and effective. An ineffective QMS leads to disastrous consequences such as medical device reports, recalls, 483s, and warning letters. An ineffective QMS can result in serious consequences for your customers leading to dissatisfaction, serious injury, or even death. It is imperative that medical device companies can effectively establish a QMS. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901489SEMINAR?trainingregistry-February-2018-SEO
  • 166 Request Info

    What is Data Integrity Issues-Types of Data Integrity Issues 2018

    Defined by the Medicines and Healthcare Products Regulatory Agency (MHRA) as "the extent which all data are complete, consistent and accurate throughout the data lifecycle", data integrity is increasingly the focus of regulatory agencies round the world. Companies must now ensure that they are appropriately addressing data integrity and data governance. This includes organizational, procedural and technical controls that must be considered as part of an overarching data governance system. In addition, the effort and resources committed to data integrity must be commensurate with the role it plays in assuring product quality. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901378SEMINAR?trainingregistry-February-2018-SEO
  • 167 Request Info

    Risk Management Education Course | Medical Devices Industry 2018

    Gaps, incorrect or incomplete implementation of software can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical device software in a regulatory compliant environment. Software risk management has to be embedded into the bigger scope of overall risk management. Therefore this course will additionally address the system level risk management and the resulting interfaces to software. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901459SEMINAR?trainingregistry-February-2018-SEO
  • 168 Request Info

    FDA Import Process | FDA Food Facility Registration 2018

    FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused. As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements or face entry refusals and monetary penalties of up to $10,000 per offense. Other factors can derail the expectation of a seamless import entry process. The course covers detailed information about the roles and responsibilities of the various parties involved with an import operation and how to correct the weakest link(s) in the commercial chain. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901399SEMINAR?trainingregistry-February-2018-SEO
  • 169 Request Info

    EU Clinical Trial Regulation Implementation | Regulatory 2018

    This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Directive and the impending changes coming to the EU through the EU Clinical Trial Regulation (for Drugs, Biologics & Combination Products). The course also covers recent updates on EU-GCP associated with the new regulatory framework, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. Additionally, the seminar will cover the impending changes coming with the EU Parliament passage of the EU Clinical Trial Regulation, which will affect all trials conducted across the EU [new and ongoing]. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901354SEMINAR?trainingregistry-February-2018-SEO
  • 170 Request Info

    HR Auditing: Identifying and Managing Key Risks

    HR audits are designed to help your organization focus its attention on its human resource management practices, policies, procedures, processes, and outcomes by providing you with a structured and systematic series of questions about key compliance, risk management, internal auditing, and human resource management issues. As a process, HR audits are designed to help your organization identify potential and actual problem areas, help assess the effectiveness of current HR management activities, help assess weaknesses in HR internal control processes, and help assess human capital strategic and compliance related risks. HR audits should additionally provide suggestions for corrective action. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901198SEMINAR?trainingregistry-February-2018-SEO
  • 171 Request Info

    HIPAA Compliance Officer Training | HIPAA Professional 2018

    This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak on specific experiences from over 17 years of experience in working as an outsourced compliance auditor, expert witness on multiple HIPAA cases, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information. More importantly I will show you how to limit those risks by simply taking proactive steps and utilizing best practices. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901507SEMINAR?trainingregistry-February-2018-SEO
  • 172 Request Info

    Why Measure Drug Plasma Levels | Drug Dissolution Testing 2018

    Drug dissolution testing is an essential and critical step for appropriate and efficient product development such as tablet and capsule. A number of approaches are used to conduct dissolution testing using different apparatuses and methods. Making a choice for an appropriate apparatus and method has always been confusing and challenging. This seminar will provide relevant pharmacokinetics and physiological background so that making this choice becomes easier and instinctive. No prior knowledge of pharmacokinetic and/or physiology is required; however, these will be explained in very simple terms to help attendees in selecting or developing a dissolution method. This seminar will describe in detail the theoretical aspect of the drug dissolution testing including method development. Pros and cons of different approaches will be explained in detail. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901498SEMINAR?trainingregistry-February-2018-SEO
  • 173 Request Info

    MDSAP Recognized Auditing Organizations-MDSAP Audit Checklist

    Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated. Understanding the regulations and requirements in your targeted markets will expedite speed-to-market of innovative products and assist patients needing access to life-saving products and technologies. Government Regulatory Authorities, needing to become more efficient with their time, are looking for ways to better use their internal resources without compromising safety in products, which become marketable. One such example is the Medical Device Single Audit Program [MDSAP], where Authorized Organizations would be allowed to carry out a single GMP audit on medical device manufacturing facilities and have it stand to support registrations across the current participating member countries: U.S. Canada, Brazil, Australia and Japan. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901160SEMINAR?trainingregistry-February-2018-SEO
  • 174 Request Info

    Medical Device Registration and Listing | Japan, Australia

    Classification systems differ from that of the United States or European Union in select countries Medical devices are classified depending on their risk level Medical devices must also comply with additional country standards and these standards define industry-wide safety and performance requirements Regulatory registration process is defined for China, Hong Kong, India, Japan, South Korea, Taiwan, Singapore and Australia The regulatory process from product design to market entry for a new medical device or IVD is oftentimes complicated and unclear. In Asia Pacific, it can become difficult to make a clear distinction between your regulatory strategy and business strategy. And Much More... Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900990SEMINAR?trainingregistry-February-2018-SEO
  • 175 Request Info

    HIPAA 2018 - Understanding Compliance Program Requirements

    Being in compliance with HIPAA in 2018 involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a breach investigation you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program. If your healthcare practice, business, or organization needs to understand how to put HIPAA compliance program in place or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive 2 day training course. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901513SEMINAR?trainingregistry-February-2018-SEO
  • 176 Request Info

    Importance of Dissolution Testing | Plasma Levels of Drug 2018

    Drug dissolution testing is an essential and critical step for appropriate and efficient product development such as tablet and capsule. A number of approaches are used to conduct dissolution testing using different apparatuses and methods. Making a choice for an appropriate apparatus and method has always been confusing and challenging. This seminar will provide relevant pharmacokinetics and physiological background so that making this choice becomes easier and instinctive. No prior knowledge of pharmacokinetic and/or physiology is required; however, these will be explained in very simple terms to help attendees in selecting or developing a dissolution method. This seminar will describe in detail the theoretical aspect of the drug dissolution testing including method development. Pros and cons of different approaches will be explained in detail. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901495SEMINAR?trainingregistry-February-2018-SEO
  • 177 Request Info

    Statistical Process Control Methods | Process Capability 2018

    This course teaches participants the fundamental concepts and methods needed to establish effective control charts and estimate process capability. In addition to learning traditional control charts (e.g. xbar, r/s), participants will be exposed to other useful charts for handling multiple sources of variation (within/between) and short production runs. Practical aspects of implementing SPC on the shop floor are also discussed. Estimating process capability for both normal and non-normal data is discussed. The meaning and limitations of popular capability are presented in detail. This highly interactive course will allow participants the opportunity to practice applying SPC techniques with various data sets. The objective is to provide participants with the key tools and knowledge to be able to apply the methods effectively for their own processes. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901441SEMINAR?trainingregistry-February-2018-SEO
  • 178 Request Info

    Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2018

    Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management. keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901453SEMINAR?trainingregistry-January-2018-SEO
  • 179 Request Info

    Product Reliability Training Courses | Product Reliability Testing

    Although a primary objective of reliability analysis is to improve product reliability, there are many possible reasons for collecting and analyzing reliability data. Several examples are the following: Assessing product reliability in the field Predicting product warranty costs Estimate replacement part/spares requirements Assessing the effect of a proposed design change Demonstrating product reliability to customers or government agencies Comparing components from multiple suppliers Comparing components from different production periods, operating environments, or materials Improving reliability through the use of laboratory experiments keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901438SEMINAR?trainingregistry-January-2018-SEO
  • 180 Request Info

    Internal Audit Checklist for Medical Devices | Quality Audit

    Quality audits are an important element in implementing and maintaining an effective Quality Management System (QMS). Audits are one of the most powerful tools that management has to assure on effective QMS. In this workshop, participants examine the various types of audits to understand their role. Internal quality audits (1st party) help a company evaluate itself. Customer/supplier audits (2nd party) play a role in an effective supplier management program; your company could be the subject of the audit. Independent audits (3rd party) can help provide assurance about the health of a QMS. keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901429SEMINAR?trainingregistry-January-2018-SEO