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  • 1 Request Info

    10-Step Risk Based Computer System Validation for SaaS/Cloud/Local Hosting

    Understand the 10-step risk based approach to validation, explore methods to decrease resource requirements, and learn how to make documentation more manageable and understandable. Why Should You Attend: This webinar will explore proven techniques that reduce validation project time, often to one-third. Attendees will learn efficient documentation strategies for computer system validation and how to increase overall system productivity. Who Will Benefit: Computer system users IT personnel QA personnel Instructor Profile: Computer System Validation’s principal, David Nettleton, is an industry leader, author, and instructor on topics pertaining to 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. Use coupon code 232082 and get 10% off on registration.
  • 2 Request Info

    1099 & W-9 Update - Complying with IRS Information Reporting Guidelines

    This IRS regulatory compliance training will focus on the rules requiring W-9 documentation and 1099 reporting. Attendees will learn the best practices to ensure compliance with IRS and avoid B-Notices. Why Should You Attend: What are the rules regarding paying and IRS reporting on independent contractors? How do I avoid the IRS CP-2100 (B-Notices)? What if my vendor claims exemption - must I obtain a W-9 anyway? Who Will Benefit: Bank Managers Compliance Officers Information Reporting Officers Tax Managers CFOs Controllers Instructor Profile: Miles Hutchinson, is a CPA and experienced businessman. He has been an auditor with PriceWaterhouseCoopers and the Chief Financial Officer of a $1 billion real estate development company. Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 3 Request Info

    14 CFR Part 298 Exemptions: It’s Impact on the Air Carrier Certification Process

    Airline personnel and managers need to understand the significance of the advantages that 14 CFR Part 298 exemptions provide CFR FAR 135 operators. This webinar will highlight the same while enabling attendees to determine when 298 exemptions apply and the criteria upon which they are based. Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Company management such as president, CEO and vice president Company management such as chief pilot and director of operations Airline legal representatives Instructor Profile: Jacques Astre served over 30 years as a supervisory aviation safety inspector, duty officer, and flight data specialist for the Federal Aviation Administration (FAA). In these positions, he carried out air carrier certification, surveillance planning and implementation, accident, incident, complaint investigations and regulatory enforcement. Use coupon code 232082 and get 10% off on registration.
  • 4 Request Info

    2015 ACH Rule Changes and Updates: Rules that Will Change Returns and Impose New Fees

    This compliance training will focus on the 2015 ACH rule changes and updates. The chief emphasis will be on the nine recently passed ballots to keep attendees updated with the new rules and avoid violations and penalties. Why Should You Attend: With the increasing movement toward an electronic, interconnected and mobile infrastructure, it’s critical that electronic payments work safely and efficiently for all users. The ACH network enables just that. By using batch processing and a store-and-forward system, it moves almost $39 trillion and 22 billion electronic financial transactions each year. Who Will Benefit: Professionals from financial institutions Risk/compliance officers Operations personnel and managers Instructor Profile: Luann S. Kohlmann serves as the vice president of WACHA/PAR, headquartered in Wisconsin. Ms. Kohlmann started her career in banking operations and joined the WACHA/PAR team in 2003. Note: Use coupon code 232082 and get 10% off on registration.
  • 5 Request Info

    2015 SEC Enforcement Initiatives and Controls to Defend Them

    This training program will detail new SEC enforcement initiatives and discuss the SEC enforcement mindset. It will also discuss SEC enforcement trends over time and controls to put in place to prevent exposure. Why Should You Attend: This webinar will highlight the newest initiatives arising from the SEC’s Enforcement Division and will provide practical information on how companies can defend themselves from SEC enforcement actions. Who Will Benefit: Compliance Officers Offices of General Counsel Compliance Personnel /Risk Assessment Professionals Internal Investigators and Auditors Operational Managers Instructor Profile: H. David Kotz presently serves as a managing director at Berkeley Research Group (BRG), a leading global expert services and consulting firm. Note: Use coupon code 232082 and get 10% off on registration.
  • 6 Request Info

    21 CFR 11 Compliance for Excel Spreadsheet

    This Excel spreadsheet compliance training will outline the FDA requirements for Excel spreadsheets used in regulated environments and provide guidance on 21 CFR Part 11 validation. Why Should You Attend: Spreadsheet applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. Who Will Benefit: Quality Managers Quality Engineers Small Business Owners Instructor Profile: Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.
  • 7 Request Info

    21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s

    This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach). Why Should You Attend: This webinar will describe exactly what is required for compliance with Part 11 and the updated European equivalent Annex 11. Who Will Benefit: Computer system users IT personnel QA personnel Managers Executives Instructor Profile: Computer System Validation’s principal, David Nettleton, is an industry leader, author, and instructor on topics pertaining to 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 8 Request Info

    21 CFR Part 11 Compliance for SaaS/Cloud Applications: 2-day In-person Seminar

    Course Description: This interactive two-day course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance. Who will Benefit: This course will benefit all who use computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications. Regulatory Affairs QA/ QC IT/IS Software Managers Note: Use coupon code REFERRAL10 and get 10% off on registration.
  • 9 Request Info

    21 CFR Part 11 compliance for software validation and SaaS/Cloud Seminar 2018

    • Finally, the instructor reviews recent FDA inspection trends and discusses how to streamline document authoring, revision, review, and approval. • This course benefits anyone that uses computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.
  • 10 Request Info

    21 CFR Part 11 compliance for software validation, data integrity and SaaS/Cloud

    Course Objectives: Understand what is expected in Part 11 and Annex 11 inspections Avoid 483 and Warning Letters Learn how to buy COTS software and qualify vendors. Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds Requirements for local, SaaS, and cloud hosting How to select resources and manage validation projects "Right size" change control methods that allows quick and safe system evolution Minimize the validation documentation to reduce costs without increasing regulatory or business risk Write test cases that trace to elements of risk management Protect intellectual property and keep electronic records safe
  • 11 Request Info

    21 CFR Part 11/Annex 11 compliance for software validation and SaaS: In-person Seminar

    This interactive one-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. Who Will Benefit: This course will benefit all who use computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 12 Request Info

    21 CFR Part 820 Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

    This quality system regulation training will explain how to apply the theory of lean documents and its corollary theory of lean configuration to present a fresh approach to complying with 21 CFR Part 820. Why Should you Attend: If you are constantly struggling to create, manage, and maintain all of the information found in controlled documents, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use. Who Will Benefit: This webinar will provide valuable assistance to Managers, Supervisors, Directors, and Vice-Presidents in the areas of: R&D Manufacturing Engineering Design Assurance Instructor Profile: Jose Mora, is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. Use coupon code 232082 and get 10% off on registration.
  • 13 Request Info

    3-Hour Virtual Seminar on CAPA for Medical Devices

    Overview: CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. This 3-hour webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. Learn how to avoid common problems and establish an efficient and effective CAPA process leading to improved quality and compliance for your company.
  • 14 Request Info

    3-Hour Virtual Seminar on FDA Imports Require Precision in 2019

    Overview: After attending this 3-Hour Virtual Seminar, you will have great understanding of how FDA and Customs and Border Protection (CBP) operate a joint program. Why should you Attend: If you understand FDA's and CBP's import program, your business can operate in a competitive way. If you do not, your customers, foreign suppliers, stockholders will see the consequences and not be forgiving.
  • 15 Request Info

    3D Printing for Manufacturing Regulated Products: FDA's Current Acceptance and Future Projections

    The webinar will discuss the current available regulatory pathways to develop FDA-regulated 3D printed products and also predictions on what to expect in the near future. Who Will Benefit: Research and development personnel involved in 3D printed products GMP and QSR personnel Regulatory affairs personnel Senior executives of pharmaceutical and device firms planning 3D printed products Instructor Profile: Dr. Mukesh Kumar, is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the regulatory affairs and quality assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. Note: Use coupon code 232082 and get 10% off on registration.
  • 16 Request Info

    3rd Annual ComplianceOnline Medical Device Summit 2017

    Why you should attend this summit Future trends of Medical Device Regulation, Risk Management, UDI, recall complaint Management etc. Listen from FDA/CDRH Directors: What is critical to Quality Get update on FDA compliance Learn more about Medical Device Single Audit Program (MDSAP) and Other Third Party Programs Explore upcoming changes in global regulation Supply Chain Optimization Criteria for Medical Device commercialization success Panel Discussion Advanced Technology How to choose Vendors/Suppliers Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 17 Request Info

    4-Hr Virtual Training: Introduction to Design of Experiments

    In this training program, attendees will understand when and why to apply DOE (design of experiments). They will also learn to identify and interpret significant factor effects and 2-factor interactions and develop predictive models to explain and optimize process/product behavior. Applying efficient fractional factorial designs in screening experiments will also be discussed. Who Will Benefit: Operations/ Production Managers Quality Assurance Managers Process or Manufacturing Engineers or Managers Product Design Engineers Scientists Instructor Profile: Steven Wachs has 25 years of wide-ranging industry experience in both technical and management positions. He has worked as a statistician at Ford Motor Company where he has extensive experience in the development of statistical models, reliability analysis, designed experimentation, and statistical process control. Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 18 Request Info

    4-Hr Virtual Training: Predicting Product Life Using Reliability Analysis

    In this training program, participants will gain awareness of the overall methodology for setting reliability targets, estimating product reliability from test data and/or field data, and determining whether or not reliability targets are achieved. Participants will also learn how to calculate sample sizes for reliability testing. Learning Objectives: Understand key aspects of reliability data Learn what an effective reliability goal/target looks like Learn how reliability performance is typically measured (e.g. reliability statistics) How to determine appropriate probability distributions to model failure data How to use reliability models to predict reliability performance Who Will Benefit: Anyone with a vested interest in product quality and reliability, such as: Product Engineers Reliability Engineers Design Engineers Quality Engineers Quality Assurance Managers Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 19 Request Info

    6-Hour Virtual Seminar - The New EU Medical Device Regulation

    In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices. In particular, the Directives on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC) are intended to be replaced by a Regulation on medical devices, while the Directive on in-vitro diagnostic medical devices (98/79/EC) is intended to be replaced by a Regulation on the same subject. The revisions therefore affected all kinds of medical devices including in vitro diagnostic medical devices, from home-use items like sticking plasters, pregnancy tests and contact lenses, to X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.
  • 20 Request Info

    6-Hour Virtual Seminar on Biostatistics for the Non-Statistician

    Why you should attend 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.