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Courses

  • 161 Request Info

    Complaints and Recalls | Complaint Handling System in Boston 2018

    Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints! This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing a complaint-handling system keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901339SEMINAR?trainingregistry-January-2018-SEO
  • 162 Request Info

    FDA General Principles of Software Validation | Cyber Security 2018

    Software's level of complexity and use is expanding at exponential levels. Likewise, the potential risks to health follow suit. Ransomeware attacks hold your software hostage until you pay hundreds or thousands of dollars. Life supporting and life sustaining healthcare grinds to a halt. Extracting personal healthcare information is another plague that has a huge financial incentive for hackers. Your software is running on thin ice. The FDA looks at software in one of three ways: Standalone, such as for a mobile app; device-based software used to control a device's performance, or simply electronic records. FDA's risk classification will gradually clarify keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901393SEMINAR?trainingregistry-January-2018-SEO
  • 163 Request Info

    What is Computerized Testing Systems | GxP Compliance Testing 2018

    Testing is the science of identifying defects, so that they can be corrected, and of demonstrating that a system meets intended requirements. Testing computerized systems is considered a fundamental verification activity and appropriate testing is a regulatory expectation as described in many regulations e.g. EU GMP Annex 11. "Evidence of appropriate testing methods and test scenarios should be demonstrated. Particularly system (process) parameter limits, data limits and error handling should be considered" The regulated company is responsible for demonstrating compliance and fitness for use. Effective testing demonstrates compliance with regulatory requirements and ensures patient safety, product quality and data integrity as a result of controlling identified risks. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901363SEMINAR?trainingregistry-January-2018-SEO
  • 164 Request Info

    What is Project Management in Pharmaceutical Industry Seminar

    Project management is a discipline that can be applied to all industries. In the pharmaceutical industry, project management is the key to addressing the unique regulatory, compliance and quality related needs of the industry. The process of clinical research and drug development, coupled with the critical issue of time to market, can use project management techniques to effectively apply scheduling, risk management, and comprehensive quality assurance and control to the process of bringing a drug to market in a safe, effective & cost-efficient way Every industry has different "stress points"-those points that are most critical to the specific product or service being delivered. The most typical stress points are schedule, cost, and quality. Depending on the project keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901435SEMINAR?trainingregistry-January-2018-SEO
  • 165 Request Info

    What is Process Validation Report | 21CFR11 Compliance Checklist 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 keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901447SEMINAR?trainingregistry-January-2018-SEO
  • 166 Request Info

    Pharmaceutical Validation Guidelines | 21 CFR Part 11 Compliance 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 keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901444SEMINAR?trainingregistry-January-2018-SEO
  • 167 Request Info

    Enhancing Employee Engagement: Beating Burnout

    Persons who are responsible for the wellness of other persons and systems, such as care providers, managers, customer service staff and administrative professionals, often face stress and burnout resulting in absenteeism, turnover, increased errors and even mortality. This can be very harmful to organizational productivity and credibility, creating costly gaps in care and services. But who cares for the care providers and other employees? Providers and professionals working in education, healthcare, sales and hospitality must be reminded how to assert themselves, set healthy boundaries and respond to stress in healthy ways. Focus groups held by HCEI across the US confirm the need to celebrate the spirit and journey of caring persons while teaching self-preservation skills for the future. When employees care for themselves first they then provide better care and services to others.
  • 168 Request Info

    Applied Statistics, with Emphasis on Risk Management in R&D, QA/QC, and Manufacturing 2017

    The 2-day seminar explains how to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows: ISO standards and FDA/MDD regulations regarding the use of statistics. Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality. Statistical Process Control Statistical methods for Design Verification Statistical methods for Product/Process Qualification Metrology: the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications How to craft "statistically valid conclusion statements" (e.g., for reports) Summary recommendations Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901366SEMINAR?trainingregistry-December-2017-SEO
  • 169 Request Info

    Applied Statistics for Scientists and Engineers 2017

    Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting validation criteria and specifications, performing measurement systems analysis (MSA), conducting stability analysis, using design of experiment (DOE) for process development and validation, developing process control charts, and determining process capability indices. Different statistical methods are required for each of these particular applications. Data and tolerance intervals are common tools used for setting acceptance criteria and specifications. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901138SEMINAR?trainingregistry-December-2017-SEO
  • 170 Request Info

    FDA's Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use 2017

    Software's level of complexity and use is expanding at exponential levels. Likewise, the potential risks to health follow suit. Ransomeware attacks hold your software hostage until you pay hundreds or thousands of dollars. Life supporting and life sustaining healthcare grinds to a halt. Extracting personal healthcare information is another plague that has a huge financial incentive for hackers. Your software is running on thin ice. The FDA looks at software in one of three ways: Standalone, such as for a mobile app; device-based software used to control a device's performance, or simply electronic records. FDA's risk classification will gradually clarify how it intends to manage the health risks with premarket and postmarket controls. What the FDA did not see was the cancer of cybersecurity attacks, the failure of interoperability, Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901106SEMINAR?trainingregistry-December-2017-SEO
  • 171 Request Info

    Why you Should be Worried about HIPAA 2017

    This seminar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits or (even worse) litigation occurs against your organization under state laws of negligence. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information all over regarding the do's and don'ts with HIPAA - I want to add clarity for compliance officers Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901048SEMINAR?trainingregistry-December-2017-SEO
  • 172 Request Info

    Data Integrity, 21 CFR 11 & Annex 11 Implementation 2017

    The Problem: We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following: Evolution of 21 CFR Part 11 and Annex 11 and Why they are Back in the News Overview and Key Requirements of Part 11 & Annex 11 How to use a Risk Based Assessment to reduce work while still achieving Data Integrity and Compliance? How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity? I often refer to 21 CFR 11 and Annex 11 as Good Software Engineering with the Documentation on Steroids! However, unless one knows how to implement Data Integrity Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901052SEMINAR?trainingregistry-December-2017-SEO
  • 173 Request Info

    Regulatory Requirements and Principles for Cleaning Validation 2017

    This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors. The program will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901170SEMINAR?trainingregistry-December-2017-SEO
  • 174 Request Info

    HR Auditing: Identifying and Managing Key Risks 2017

    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-December-2017-SEO
  • 175 Request Info

    Quality by Design using Design of Experiments (QbD) 2017

    This seminar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles using design of experiments (DOE). In addition, this course teaches the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance documents. Using a QbD approach for pharmaceutical development studies should include a systematic understanding of the process and using this understanding to establish a control strategy as part of a comprehensive quality risk management program. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901134SEMINAR?trainingregistry-December-2017-SEO
  • 176 Request Info

    Celebrating Ourselves: Beating Burnout

    Who cares for the care provider? Both paid and non-paid persons who offer their compassion, skills and resources to those in need are often at risk for burnout, compassion fatigue or vicarious traumatization, creating costly health and emotional challenges and also gaps in expertise and caring. Care providers must be reminded how to assert themselves, set healthy boundaries and respond to stress in healthy ways. Focus groups held by HCEI across the US confirm the need to celebrate the spirit and journey of caring persons while teaching self-preservation skills for the future. When caring persons care for themselves they provide better care for others. Seminar participants will be able to: Understand dynamics of providing care Articulate how each person experiences stress uniquely Identify symptoms of compassion fatigue Utilize practical, proven solutions and exercises for stress reduction Set healthy goals and create a future response plan for stress.
  • 177 Request Info

    HIPAA Privacy, Security and Breach Notification Compliance 2017

    This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associates. The session provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate. Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901357SEMINAR?trainingregistry-November-2017-SEO
  • 178 Request Info

    Biostatistics for the Non-Statistician 2017

    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? Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901312SEMINAR?trainingregistry-November-2017-SEO
  • 179 Request Info

    FDA Scrutiny of Promotion and Advertising Practices 2017

    If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901102SEMINAR?trainingregistry-November-2017-SEO
  • 180 Request Info

    Auditing Analytical Laboratories for FDA Compliance 2017

    Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901324SEMINAR?trainingregistry-November-2017-SEO