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Courses

  • 1 Request Info

    Medical Device Software: An Incremental Approach to Risk and Quality Management 2017

    Engineers are dedicated to making things work, so a focus on how they might fail and harm someone can seem alien. Managing risk, however, is essential for all medical products- medical devices, including those involving software, have produced some painful examples of poor risk management with serious consequences. Experience has shown that there is a better way, that it is possible to manage risk in a changing business and technical world. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901342SEMINAR?trainingregistry-November-2017-SEO
  • 2 Request Info

    Onsite GCP Review and Update including the all-important 'Investigators Responsibility' 2017

    Engineers are dedicated to making things work, so a focus on how they might fail and harm someone can seem alien. Managing risk, however, is essential for all medical products- medical devices, including those involving software, have produced some painful examples of poor risk management with serious consequences. Experience has shown that there is a better way, that it is possible to manage risk in a changing business and technical world. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901348SEMINAR?trainingregistry-November-2017-SEO
  • 3 Request Info

    Combination Products 2017

    This seminar provides Professionals working in this area with A thorough understanding of the complexities involved All the relevant regulations and guidelines Real life examples of how to register and maintain various types of combination products Interfaces: Change Management and LCM Compliant safety reporting for combination products Documentation requirements and interfacing Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901066SEMINAR?trainingregistry-September-2017-SEO
  • 4 Request Info

    Leadership and Team Development for Managerial Success 2017

    Inspire and influence your team members to achieve your goals as a team! Managers who will be promoted are the ones who not only manage efficiently but also lead their teams effectively. Learn how to work in a horizontal mode of operation.. apply a consistent theory in leading your team.. and teach critical leadership skills to members of your team, so each and every one of them can lead the team in your absence. Why should you attend: Would you like to learn more about the differences between leading and managing? What about understanding how to more clearly visualize your goals and communicate them to your team? How about being able to better target your team's efforts? Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901082SEMINAR?trainingregistry-September-2017-SEO
  • 5 Request Info

    Writing and implementing effective SOP 2017

    An SOP is a meticulous step-by-step description of how to do a task that leave no chance for errors and divergence. Writing a good SOP is not an easy job. It requires a firm understanding of the task to be described, an ability to describe in specific unique to that laboratory. Writing, implementing, maintaining and assessing, revising an SOP are all different and necessary jobs. Many people must continuously be involved in these steps. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901140SEMINAR?trainingregistry-September-2017-SEO
  • 6 Request Info

    Validation of Computer Systems for Quality and Software Embedded Medical Devices 2017

    Understand Verification and Validation, differences and how they work together Develop a "Working Definition" of V&V, Qualification, and related terms Discuss recent regulatory expectations Software Verification & Validation requirements of the FDA and ISO. The latest FDA Software Guidance & Regulations, including Part 11 -impact on V&V strategies Device and Manufacturing software requirements for V & V How to determine & demonstrate an appropriate V & V strategy Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900974SEMINAR?trainingregistry-September-2017-SEO
  • 7 Request Info

    Project Management for Non-Project Managers 2017

    This two-day seminar will begin by laying the foundation for the subject by first defining what a project is and then discussing the unique roles that the project manager must assume along the length of any project. The Triple Constraint, the most fundamental of project management principles, will be explained in detail with examples and tools provided that can be used to integrate the principle into any project management process. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900996SEMINAR?trainingregistry-September-2017-SEO
  • 8 Request Info

    Applied Statistics for FDA Process Validation

    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. Simple linear regression and analysis-of-covariance (ANCOVA) are used for setting expiries and conducting stability analysis studies. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901146SEMINAR?trainingregistry-September-2017-SEO
  • 9 Request Info

    Applied Statistics for FDA Process Validation 2017

    In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further delineates the 'process design stage through commercial production' into three distinct stages of the product lifecycle: Stage 1: Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities. Stage 2: Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901142SEMINAR?trainingregistry-September-2017-SEO
  • 10 Request Info

    Overview of Device Regulation - FDA 2017- Before 30 April 50% Discount for its All Seminars

    This course provides a basic description of an FDA regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful strategies for medical devices, including definitions and classifications, elements of regulatory strategy, sources of regulatory intelligence, selection of development and product clearance/approval pathways. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900902SEMINAR?trainingregistry_SEO
  • 11 Request Info

    Risk Management in Medical Devices Industry 2017- Before 30 April 50% Discount for its All Seminars

    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=900890SEMINAR?trainingregistry_SEO
  • 12 Request Info

    HIPAA Compliance for Small Healthcare Providers 2017- Before 30 April 50% Discount for its All Seminars

    Being in compliance with HIPAA involves not only ensuring that you provide the appropriate patient rights and controls on your uses and disclosures of Protected Health Information; but that you also have the proper policies and procedures in place. If audited or the subject of a compliance review, 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 small healthcare practice needs to understand how to put a 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 Two-day training course. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901022SEMINAR?trainingregistry_SEO
  • 13 Request Info

    Writing and implementing effective SOP's 2017- Before 30 April 50% Discount for its All Seminars

    An SOP is a meticulous step-by-step description of how to do a task that leave no chance for errors and divergence. Writing a good SOP is not an easy job. It requires a firm understanding of the task to be described, an ability to describe in specific unique to that laboratory. Writing, implementing, maintaining and assessing, revising an SOP are all different and necessary jobs. Many people must continuously be involved in these steps. Even a standardized method, such as an ASTM or IP method, is insufficiently written to pass as a well-written and compliant SOP. The reasons why will be described, as will the steps needed to convert a standard method into an SOP. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900914SEMINAR?trainingregistry_SEO
  • 14 Request Info

    Laboratory, Medical and Device Performance and Validation following Regulatory 2017-Before 30 April 50% Discount for its All Seminars

    This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts one uses when investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and quality control. One also considers ICH Q8 and Q9. These techniques covers both clinical and laboratory applications. This applies to many areas such as stability testing, outlier analysis and risk management. It is not a course in statistics but introduces the participant to an applied approach to the statistical techniques one uses, how they are reasonably interpreted. One will address the various challenges facing pharmaceutical and biotechnology companies when it comes to quantifying results in a meaningful interpretable manner through tabulations and graphical presentations. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900930SEMINAR?trainingregistry_SEO
  • 15 Request Info

    HIPAA Compliance Training 2017- Before 30 April 50% Discount for its All Seminars

    This two day seminar takes the participants through HIPAA compliance from start to compliance. The first presentation explains the history of HIPAA, why it came to being and its evolution. This covers what HIPAA is, what steps have to be performed to be HIPAA compliant and what HIPAA compliance is. It also provides definitions to key HIPAA terms, how to define a Business Associate and how to contract with Business Associates. The second part of the first presentation is an overview of how to manage the HIPAA compliance project. At the end of these presentations there will be a workshop to demonstrate how to use these tools. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900876SEMINAR?trainingregistry_SEO
  • 16 Request Info

    Audit Like the FDA Audit Like the FDA 2017- Before 30 April 50% Discount for its All Seminars

    This 2 day seminar will explore how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. A well-designed audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk. However, estimates indicate that up to 75% of companies conduct audits only because they are required to by regulation. Businesses often see internal audit as a non-value added activity leading to meaningless findings, bureaucracy, and cumbersome processes. And despite having an internal audit program, management is often surprised when they receive a 483, Warning Letter, or even a Consent Decree. A well planned audit program can reduce these risks. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900854SEMINAR?trainingregistry_SEO
  • 17 Request Info

    How to build a complete Safety, Health & Environment Management System through Standards & Practices 2017

    A management system, by definition, is a process by which a function or functions are carried out in an organization by a series of hierarchal documents that are prescriptive, and set a particular path on which the organization manages its day-to-day operations. A management system can be for one function, but more often than not, it incorporates many functions. Functions like accounting, engineering, banking, etc. have their own management systems, and the Safety, Health and Environmental, as well as Training and Security should have their own management system. This brings efficiency, consistency, cost effectiveness and timeliness to the entire process. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900844SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 18 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=900802SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 19 Request Info

    Why is FDA at my facility, and what do I do during an inspection 2017

    Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900762SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 20 Request Info

    The Complete Payroll Law and Best Payroll Service 2017

    This course covers a very broad range of topics from worker classification, to employee classification, to establishing methods and rates of pay, what must be included in the rate of pay, hours that must be compensated as worked time, required benefits, de minimus working fringes, withholdings and deductions from pay, voluntary deductions, child support and garnishment orders, payroll reporting, analysis of risks of noncompliance, proper documentation of your policies and procedures and record retention requirements. We will show where to find the laws, how to interpret them and how to apply them in the most effective ways. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900840SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO