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Courses

  • 21 Request Info

    Webinar on FDA Warning Letter - Consent Decree Software Validation

    This training on FDA software validation related warning letters will discuss what to do to avoid additional software related compliance issues along with the response steps where the citations directly or indirectly include automated system. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/FDA-Warning-Letter-Consent-Decree-Software-Validation-505191/FEBRUARY-2018-ES-TRAININGREGISTRY
  • 22 Request Info

    Webinar on FDA QSR and ISO 13485 Requirements for Supplier Management

    This webinar will review in detail the FDA QSR and ISO requirements for supplier evaluation and assessment, and discuss cost effective options for many of the common practices for achieving compliance. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/BEST-PRACTICES-FOR-LEAN-SUPPLIER-MANAGEMENT-IN-COMPLIANCE-WITH-FDA-AND-ISO-13485-REQUIREMENTS-505073/NOVEMBER-2017-ES-TRAININGREGISTRY
  • 23 Request Info

    Webinar on Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program

    cGMP drug products rely on the bacterial endotoxin test as a critical release test for products based on the route of administration of the drug product. Having a good concept of this critical release assay, its application and importance to the manufacture of cGMP product is valuable so as to avoid costly errors, batch disposal, expensive failure investigations and delays in the release of products that some manufacturers have undergone. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/REGULATORY-AND-TESTING-REQUIREMENTS-OF-THE-BACTERIAL-ENDOTOXIN-TESTING-BET-OR-LAL-PROGRAM-507120/NOVEMBER-2017-ES-TRAININGREGISTRY
  • 24 Request Info

    Webinar on Qualification of Contract Manufacturer Organizations Based on Practical Experience

    This webinar will cover in detail the steps to plan and conduct a program to qualify contract manufacturer organizations (CMOs). It will teach best practices to meet regulatory requirements and satisfy practical needs to obtain the best CMO. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://onlinecompliancepanel.com/webinar/QUALIFICATION-OF-CONTRACT-MANUFACTURER-ORGANIZATIONS-505388/NOVEMBER-2017-ES-TRAININGREGISTRY
  • 25 Request Info

    Webinar On Top Process Validation Mistakes - And How to Avoid Them

    Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the essentials of validation. You’ll learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol writing, and change management. We’ll cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices. We’ll discuss the top mistakes that companies make and how you can avoid them..Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/TOP-PROCESS-VALIDATION-MISTAKES-509627/AUGUST-2017-ES-TRAININGREGISTRY
  • 26 Request Info

    Webinar On Quality by Design (QbD) for Analytical Methods

    There are always certain steps in a method where control is critical either because this step contributes a lot to the overall uncertainty or its uncertainty is more likely to change from common causes. These critical points can be assessed and a monitoring program instituted. This data is then collected and plotted on a control chart. Using Nelson's rules of statistical use of control charts, the individual uncertainties are monitored. This allows for early observation and intervention before a non-compliance occurs..Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/QUALITY-DESIGN-ANALYTICAL-METHOD-502373/AUGUST-2017-ES-TRAININGREGISTRY
  • 27 Request Info

    Webinar On Pharmaceutical Quality Risk Management (QRM) Overview

    Per ICH Q10 Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. However integrating the principles of QRM into our quality processes is complex especially in a pharmaceutical organization.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/PHARMACEUTICAL-QUALITY-RISK-MANAGEMENT-506610/JULY-2017-ES-TRAININGREGISTRY
  • 28 Request Info

    Webinar On Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data

    Year after year, CAPA is the subsystem cited most frequently during FDA inspections. A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer. A system that identifies and eliminates non-conformances and potential non-conformances enables both regulatory compliance and cost savings. This session will discuss the importance, requirements, and elements of a CAPA program, as well as describing the uses of CAPA data. Application of risk management to your CAPA program will be discussed throughout the webinar.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/CAPA-PROGRAM-CAPA-DATA-505212/MAY-2017-ES-TRAININGREGISTRY
  • 29 Request Info

    Webinar On How to Buy COTS Software, Audit Vendors and Validate the Software

    This presentation will focus on instructing attendees on best practices for buying COTS (Commercial Off-The-Shelf) software and evaluating software vendor(s). Presentation will highlight essential data and systems subject to Part 11 & Annex 11 (ERES - Electronic Records and Electronic Signatures) compliance while listing requirements for IT infrastructure, Laboratories, Manufacturing/ Operations, R&D, Regulatory and other GxP relevant areas of an FDA regulated manufacturer. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/COTS-SOFTWARE-AUDIT-VENDORS-505707/MARCH-2017-ES-TRAININGREGISTRY
  • 30 Request Info

    Webinar On Good Laboratory Practice Regulations - Lab Proficiency Testing

    This webinar is designed to provide both a regulatory compliant and practical overview of Good Laboratory Practice (GLP) requirements (21 CFR 58). GLP is both critical in meeting current regulatory requirements, and in ensuring efficient and cost-saving quality laboratory operations.GLP regulations span general provisions, organization and personnel, facilities to records and reports. FDA regulatory compliance requirements will be reviewed, along with discussing a practical overview of establishing an effective and efficient quality laboratory operation. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/GOOD-LABORATORY-PRACTICE-REGULATIONS-502984/FEBRUARY-2017-ES-TRAININGREGISTRY
  • 31 Request Info

    Webinar On Clinical System Data Management Validation

    Have you validated your clinical data base? Do you have the proper documentation in the event of a regulatory inspection? In this course we will cover considerations and requirements for validation of clinical data management systems. We will discuss the challenges and strategies of risk based validation and review 21 CFR Part 11 expectations. We will discuss the importance of a change control process.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/CLINICAL-DATA-MANAGEMENET-501926/DECEMBER-2016-ES-TRAININGREGISTRY
  • 32 Request Info

    Webinar On Conducting a Software Validation of Medical Device to Meet FDA Requirements

    This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is not a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/SOFTWARE-VALIDATION-MEDICAL-DEVICE-501884/NOVEMBER-2016-ES-TRAININGREGISTRY
  • 33 Request Info

    Webinar On Achieving Vendor Assurance through SOC-1 Reports

    IT outsourcing continues to grow with no signs of slowing. As organizations continue to use service providers to perform various IT tasks, it becomes more important to set up a compliance program that assesses the performance of those service providers. One well known way is with the SOC-1 Type II report. This is also known as a SSAE-16 report.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/ACHIEVING-VENDOR-ASSURANCE-SOC-1-501887/NOVEMBER-2016-ES-TRAININGREGISTRY
  • 34 Request Info

    Webinar On From Volume to Value: An Overview of MACRA, MIPS, APMs and the New CMS Quality Payment Program

    In this session Mr. Wolfe will help highlight key components of the anticipated 962 page proposed rule (Proposed Rule). Discussion will include overview of CMS's new Quality Payment Program. Mr. Wolfe will provide a straight-forward, practical explanation of key MACRA provisions and the Quality Payment Program, including the timing and features of new MIPS and APM incentive implementation.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/MACRA-MIPS-APMs-CMS-QUALITY-501808/OCTOBER-2016-ES-TRAININGREGISTRY
  • 35 Request Info

    Webinar On Enhancing your CAPA Program by Developing a Learning Organization

    This Webinar provides tools needed to sell a meaningful CAPA program up to Management, by discussing how CAPA can be used as a tool to yield business results. This well-researched webinar references classic business literature, written by famous business minds, such as Peter Drucker and Peter Senge, to describe how a CAPA program appeals to the needs of Knowledge Workers in a Learning Organization, CAPA therefore becomes a business tool to un-learn behaviors that are thwarting progress in the organization, and becomes a tool for sustainable change, organization alignment and business risk management.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/ENHANCING-CAPA-PROGRAM-LEARNING-ORGANIZATON-501459/JUNE-2016-ES-TRAININGREGISTRY
  • 36 Request Info

    Webinar On Transfer of Analytical Methods and Procedures according to USP 1224

    When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has published an updated general chapter <1224>.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/TRANSFER-ANALYTICAL-PROCEDURES-USP-1224-501440/JUNE-2016-ES-TRAININGREGISTRY
  • 37 Request Info

    Webinar on Driving a Quality-Lean Steering Committee

    Overview: This session demonstrates how to develop, manage, and implement an effective quality Lean Management System (QLMS) steering committee. Attendees will observe the development of the key components of a steering committee. Why should you Attend: Medium to large-sized companies often need an oversight group build into their business culture to help lead the implementation of quality and lean systems. Usually, this is in the form of a Steering Committee. Speaker Profile: Jd Marhevko has served as Vice President of Quality and Lean for Accuride Corporation since April 2012, having joined the company as Vice President, Quality in January 2012. She has been involved in Operations and Quality/Lean/Six Sigma efforts across a variety of industries. Contact Detail: NetZealous - Compliance4All, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: support@compliance4All.com http://www.compliance4all.com/ Event Link : http://bit.ly/1NLnbr
  • 38 Request Info

    Webinar on Analytical Instrument Qualification According The New Revision of USP 1058

    Overview: The first version of USP <1058> has been released in 2008. Since then it has evolved as the global standard for analytical instrument qualification, despite of some deficiencies of the first version. Areas Covered in the Session: Scope and principles of the new revision. Changes to the existing chapter Approaches for risk based qualification Who Will Benefit: QC managers QA managers and personnel Analysts and lab managers Speaker Profile Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare". Contact Detail: NetZealous - Compliance4All, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: support@compliance4All.com http://www.compliance4all.com/ Event Link : http://bit.ly/1L4WgHV