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Courses

  • 1 Request Info

    Seminar on 21 CFR Part 11 compliance for software validation and SaaS/Cloud

    This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.
  • 2 Request Info

    The New Clinical Trials Regulation and Regulatory Affairs Aspects 2017

    The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to consider. The regulatory plan describes the regulatory strategy, as well as pricing and reimbursement issues in your development. Orphan medicinal Products will be discussed, and the advantages of having a status as an orphan medicinal product will be explained. Scientific advice is a vital element in the development of a medicinal product, and knowledge of the how to choose between national and EU scientific advice, as well as the preparation and procedure is vital for a successful outcome Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900936SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 3 Request Info

    FDA Data Integrity for Computerized Systems 2017 | 21 CFR 11

    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=900944SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 4 Request Info

    Seminar on Product Information for Medicinal Products in the EU 2017

    Regular review and monitoring of product information for medicines is important, to support awareness of relevant updates/changes which may affect prescribing, dispensing, administration or monitoring practices. It is also important that patients and caregivers, as appropriate, are made aware of the information contained in the Package Leaflet (PL) and should be encouraged to read it prior to and during their treatment.
  • 5 Request Info

    Seminar on FDA Data Integrity for Computerized Systems in Mumbai

    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, it is often very hard to apply requirements for DATA INTEGRITY to computerized system, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements.
  • 6 Request Info

    Cosmetics Product Regulation - Four Years after its implementation

    Overview: Since July 2013, Regulation (EC) No 1223/2009 on Cosmetic Products of the EU has been fully implemented and represents a modern regulatory framework grounded on state of the art of cosmetic science and product technology. It is structured in regulatory modules, which include the safety assessment and the Cosmetic Product Safety Report (CPSR), Product Information File (PIF), Responsible Person (RP), label information, cosmetovigilance, substance regulations, claims, etc. Location: Zurich, Switzerland Date: June 8th & 9th, 2017 and Time: 9:00 AM to 6:00 PM Venue: Hilton Zurich Airport Address: Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50
  • 7 Request Info

    Medical Devices Industry and Risk Management 2017

    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=900888SEMINAR?channel=mailer&camp=Seminar&AdGroup=austinmonthly_April_2017_SEO
  • 8 Request Info

    Conducting Internal Investigations 2017

    t seems that employees love to complain about anything, and it seems impossible to investigate everything. When employees feel, however, that you are not taking their complaints seriously enough or that you are ignoring them, they will find external sources for their complaints. These external sources range anywhere from the EEOC, the NLRB, Wage and Hour, private attorneys, and juries!! And juries love to punish you when they feel that you ignored an employee's legitimate complaint. But what are legitimate complaints? We all know that an employer has a legal responsibility to investigate some complaints but not others. Can you make the distinction? How you handle internal complaints can make all the difference of whether an employee goes externally with their complaints. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900872SEMINAR?channel=mailer&camp=Seminar&AdGroup=austinmonthly_April_2017_SEO
  • 9 Request Info

    Leadership Management Academy 201-202: Rising Through the Management Ranks 2017

    Why Should You Attend? By attending, you will take advantage of a great opportunity to advance as a manager to the next level! Too often, we focus on getting things done and results and miss working on our self-development. Let's face it: this is how we get paid yet this is also how we keep falling behind when it comes to our careers. It's time to get ahead! Don't miss an opportunity to advance as a manager again! We'll take you through peer discussions addressing leading and managing, integrating finance and quality, managing your time effectively, managing performance and managing up. Join us as we help you report back to your manager that "I'm ready to take the next step in advancing my management career!" Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900866SEMINAR?channel=mailer&camp=Seminar&AdGroup=austinmonthly_April_2017_SEO
  • 10 Request Info

    Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals 2017

    This workshop style training course is designed based on 30 year of regulatory affairs experience in preparing more than 150 successful U.S. FDA submissions for major medical device companies. In these 2 days, the following essential elements of U.S FDA premarket submissions will be covered: History and background of U.S FDA Laws and Regulations Classify Your Device Choose the Correct Premarket Submission for your device Compile the Appropriate Information for your Premarket Submission Author and Prepare your Premarket Submission Submit your Premarket Submission to the FDA Interact with FDA Staff during Review and Approval Complete the Establishment Registration and Device Listing Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900778SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 11 Request Info

    Implementing ISO 13485:2016- 2017

    The final version of ISO 13485:2016 is now available and companies should be planning their implementation. There are significant changes from the earlier version; they will require major modifications to the Quality Management System (QMS). The new version has better alignment with FDA's QSR, but there are still major differences that create issues for effective QMS implementation. This workshop covers the differences from the 2003 version to the 2016 version and offers practical implementation advice to update your QMS. Participants will also learn the differences with QSR and understand how to resolve them. The workshop uses extensive examples and exercises to help clarify the concerns. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900766SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 12 Request Info

    Overview of Device Regulation – FDA 2017

    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=900900SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 13 Request Info

    Common Frauds: Creating and Improving Anti-Fraud Controls for Businesses 2017

    This course will address the risks to a business from data breaches, various forms of cyberfraud and identity theft. We will discuss the legal issues with data breaches including issues for companies that are victims of data breaches. We will review the best practices for data security. Attendees will be given examples of cyberfrauds, including information on how they occur and internal controls that can help to prevent them. The new requirements for IT controls included in the 2013 COSO update will be discussed. The types of identity theft and methods used by criminals will be discussed, also how individuals and businesses can protect themselves from identity thieves. The new credit card rules will be reviewed. The compliance requirements of the Federal Trade Commission's Red Flags Rules will be reviewed. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900862SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 14 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=900806SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 15 Request Info

    Writing and implementing effective SOP's 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. 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=900912SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 16 Request Info

    Introduction to Industrial Statistics 2017

    This is an introductory course in industrial statistics that will equip the attendee to understand what he or she needs to know about basic descriptive statistics such as measurements of central tendency (average) and variation (range and standard deviation), and to use graphical methods such as the box and whisker plot to visualize these statistics for data sets. The concepts of variation and accuracy, and their effects on outgoing quality, will be introduced at the beginning. The basic data visualization tools of the histogram and Pareto chart also will be presented. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900904SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 17 Request Info

    Quality by Design - Essential Techniques for Medical Devices 2017

    Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet, Design Controls are still one of the most frequent areas for 483 and Warning Letter observations. This 2 day seminar will help you understand, develop, and implement design controls processes and tools that are a competitive strength for your company. You will learn how to incorporate design controls into your product development process to help streamline development and ensure quality and compliance. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900852SEMINAR?channel=mailer&camp=Seminar&AdGroup=austinmonthly_April_2017_SEO
  • 18 Request Info

    Preparing to Comply with the New FDA FSMA Rules: Planning Valid Preventive Food Safety Controls 2017

    Upon completing this course participants will leave with a preliminary preventive control implementation plan and will: Understand US FDA final rules for the Preventive Controls for Human and Animal Foods Define and review your current system to identify gaps in your preventive controls planning. Be able to develop and implement a valid preventive control company food safety plan to close any gaps Write and implement appropriate procedures. Know your requirements for control over your supply chain Be able to plan and implement HARPC Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900814SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 19 Request Info

    HIPAA Training Programs 2017

    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 2017 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. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900786SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 20 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