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  • 61 Request Info

    Master HIPAA Compliance in Six Steps

    Overview: The secret is - HIPAA Rules are easy and routine to follow - when they are explained step-by-step in plain language. In this seminar Paul Hales will capture your attention with visual presentations, discussion and learning exercises and show how to find the right rule with the step-by-step procedures you need when you need them. Seminar Takeaways: Thorough Understanding of HIPAA Rules • What they are • How they work together • Why and How they were made • How they are changing and what to expect next HIPAA Risk Analysis - Risk Management for Your Organization • A Practical Guided Exercise done in class on your computer to take home Privacy and Security Rules - Permitted and Required Uses and Disclosures • What information must be protected • Administrative, Technical and Physical Safeguards • Social Media, Texting and Emailing Patients Venue: The Doubletree Baltimore-BWI Airport Address: 890 Elkridge Landing Road - Linthicum, MD 21090
  • 62 Request Info

    Best Practices for FDA Inspection 2016

    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. Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favorable outcome. Venue: Embassy Suites Boston at Logan Airport Address: 207 Porter St. Boston, MA 02128
  • 63 Request Info

    Design Verification data and Process Validation 2016

    This 2-day seminar provides a 1-day introduction to the statistical tools used to analyze Design Verification data and Process Validation results. The entire 2nd day is spent on Statistical Process Control and Process Capability Indices. The goal of the 1st day is to help the student understand how to choose statistical methods and sample sizes, and to correctly interpret the results. The goal of the 2nd say is to explain how to monitor a validated production process, using tools that can also help improve product quality. Venue: Courtyard Houston Downtown /Convention Center Address: 916 Dallas Street Houston Texas 77002 USA Phone: +1 832-366-1600 Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://bit.ly/2e8BvgT-Statistical-Methods
  • 64 Request Info

    GMP requirements for quality control and contract laboratories 2017

    Quality control and related contract laboratories are considered at high risk because after testing and approval, drug products and Active Pharmaceutical Ingredients (APIs) are released to the market without further check. That's the reason why the FDA and other agencies put highest emphasis on inspections of QC laboratories. Even though cGMP regulations have been in place since long time, the large number of QC related 483's and warning letters demonstrate that companies have problems with implementation. This two day interactive in-person seminar will provide participants the regulatory background and guidelines through all critical areas of GMP compliance. This course helps attendees understand the latest requirements and also provides them templates and examples to develop inspection ready documentation. Venue: Mandarin Orchard Singapore Address: 333 Orchard Road, Singapore 238867 Tel: (65) 6235 7788 Registration Link - http://bit.ly/2dQJOPo-GMP-compliance
  • 65 Request Info

    Seminar on HIPAA Security & Privacy Official - Roles and Responsibilities 2017

    Being the HIPAA Security and Privacy Official involves not only ensuring you know 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 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. Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://bit.ly/2eMW0Cs-HIPAA-Security-Privacy Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
  • 66 Request Info

    Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC) 2017

    This workshop style training course is supported by comprehensive knowledge of U.S. FDA laws and regulations and 30 year of extensive experience working within in the U.S. FDA regulated industries. In these 2 days, the following essential topics will be covered: • Total Product Life Cycle and Your Medical Device • An Overview of U.S. FDA Medical Device Regulation • Regulations for Design and Product Development • Premarket Notification - 510(k) and Premarket Approval (PMA) • Regulations for Production & Process Control • Readiness for FDA Facility Inspection Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://bit.ly/2fGMba3-US-FDA-Laws Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
  • 67 Request Info

    Seminar on 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. Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://bit.ly/2eqHQWM-Statistics-for-Scientists Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
  • 68 Request Info

    Seminar on Verification vs. Validation - Product Process Software and QMS 2017

    This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources. Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://bit.ly/2e4Js9T-Verification-Validation
  • 69 Request Info

    2017 Conference on Applying ISO14971 and IEC62304 - A guide to practical Risk Management

    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. Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://bit.ly/2eXBzCw-ISO14971-and-IEC62304 Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
  • 70 Request Info

    Conference on Effective Complaint Handling, Medical Device Reporting and Recalls 2017

    An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product. Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://bit.ly/2eXtpde-Effective-Complaint
  • 71 Request Info

    Seminar on The Simple Secret to HIPAA Compliance Breaking down each Rule into Steps for Your Organization 2017

    The secret is - HIPAA Rules are easy and routine to follow - when they are explained step-by-step in plain language. In this seminar Paul Hales will capture your attention with visual presentations, discussion and learning exercises and show how to find the right rule with the step-by-step procedures you need when you need them. Seminar Takeaways Thorough Understanding of HIPAA Rules • What they are • How they work together • Why and How they were made • How they are changing and what to expect next Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://bit.ly/2fhCIDC-Simple-Secret-to-HIPAA Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
  • 72 Request Info

    Seminar on Design of Experiments (DOE) for Process Development and Validation 2017

    This course will begin by presenting a primer on statistical analysis, focusing on the methods required for analysis of designed experiments. It will then present the steps to DOE, while demonstrating valuable risk management tools (Ishikawa and FMEA) which can be use pre and post DOE studies. Next, participants will learn to generate and analyze multiple screening and response surface designs; the participants will leave with an understanding of why and how each are used. Then, the participants will learn how results of the studies can be presented. Lastly, using the results of the studies, the risk management tools will then be updated. Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://bit.ly/2f3NbkT-Design-of-Experiments Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
  • 73 Request Info

    Seminar on 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. Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://bit.ly/2ffpWVv-HIPAA-Privacy Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
  • 74 Request Info

    2017 Conference on Implementing ISO 13485:2016

    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. Quick Contact: NetZealous DBA GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://bit.ly/2er7KJN-Implementing-ISO Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
  • 75 Request Info

    Conference on New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods 2017

    Transportation and Logistics food transportation food safety rules are currently being finalized by the U.S. Food and Drug Administration (FDA). Under congressional instructions, the Food Safety Modernization Act (FSMA) requires the FDA to establish rules to improve, audit and enforce new food transportation rules. The rules provide a significant focus on foods not completely enclosed by a container, risk reducing adulteration prevention, personnel training and certification, inspection and data collection, maintenance and reporting that provides evidence of compliance. Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com/ Registration Link - http://bit.ly/2eQ9ev7-New-FDA-FSMA-Rules Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
  • 76 Request Info

    2017 Seminar on Leadership and Team Development for Managerial Success

    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. Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://bit.ly/2fyjJob-Leadership-and-Team-Development Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
  • 77 Request Info

    Seminar on Extracting information from geochemical data 2017

    Overview: Most specialists strongly recommend to sample every meter of the drill core or of a trench and to use multielement analysis, rather than just asking the laboratory for gold test. There are also many other types of analysis that are ignored by the industry. But even when such analyses are requested, most of the time the fed geologist is not well trained on the necessary techniques and methods to extract all the information contained in the data. This seminar will teach you what to ask and how to extract all the important information of your data Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://bit.ly/2ek01Pt-geochemical-data Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
  • 78 Request Info

    Seminar on Regulatory Requirements and Principles for Cleaning Validation 2017

    Overview: 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. Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://bit.ly/2eCdVrx-Regulatory-Requirements Follow us: https://www.linkedin.com/company/globalcompliancepanel
  • 79 Request Info

    Seminar on HIPAA - Understanding Compliance Program Requirements

    Overview: Being in compliance with HIPAA 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 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. Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com
  • 80 Request Info

    Seminar on Quality by Design using Design of Experiments (QbD)

    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. Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com