Quality Management

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Courses

  • 1 Request Info

    Introduction to Compound Pharmacy Regulatory Compliance

    Ever since major issues with Compound Pharmacy manufacturing came into the spotlight in late 2012, the FDA has been actively working to put regulation in place to prevent such occurrences from happening in the future. While this has been a good change for consumers, many Compound Pharmacies have been struggling to understand these new requirements and apply them to their facilities and processes. It is true that many of the principles and regulations are standard in the “Pharmaceutical Industry”, but Compound Pharmacy facilities do not necessarily fit in that category, and so some of these practices and requirements may not be familiar to them. It may be logical to hire consultants to come in to do the work, but many compound pharmacies do not find this cost effective. In addition, many find that implementation and changes can be easily made in house, once they understand the requirements and their intent. Participants will learn what the FDA requirements are regarding . . .
  • 2 Request Info

    Online Webinar on Blue Print for Implementing Pharmaceutical and Medical Device Quality Management System under one Umbrella

    In this webinar, the presenter with 1st hand proficiency in setting up and speaking the quality language of medical device and the pharma world will provide unique tips for those companies that are making the transition from medical device to pharmaceuticals and vice versa.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/DEVICE-QUALITY-MGMT-SYSTEM-501262/FEB-2016-ES-TRAININGREGISTRY
  • 3 Request Info

    Integration of Risk Management Principles and Activities into the Quality System

    The market’s Tolerance for Failure of Drugs, Devices and IVDs has reduced significantly since the 80s. This reduced tolerance is a reflection of a general loss of confidence in the medical industry. Adoption and certification of Quality Management Systems (QMS) has provided some recovery of that lost confidence but not enough – more is needed New requirements combined with concepts and applications of Risk Management as a practical set of principles, have emerged and when integrated with Quality Management Systems re-build confidence for the three major stakeholder groups: Regulators, Industry and most importantly the Medical Community - including users & patients. This course will cover Risk Management principals associated standards and practices together with how to develop, apply and implement strategies that reduce risks in the areas of drugs, devices and IVDs while working within established Quality Management Systems. Topics covered include: •Current US and international . .
  • 4 Request Info

    Validation of Computer Systems

    This course focuses on developing and implementing regulated computer systems with an appropriate level of documented evidence to satisfy FDA expectations. The course targets deliverable document content and how to avoid rework and unnecessary expense through a proactive approach. The core elements of a satisfactory computer validation program will be emphasized. Topics to be discussed include: •The regulatory expectations for computer validation •Relevant FDA warning letters •The tasks and deliverables expected for computer validation •Why validation processes vary so much •Strategies for practical, yet defensible computer validation •Sops required for system operation and maintenance •21 CFR part 11 and it's implications for common regulations •An active discussion of part 11 examples and audience questions •The implications of GAMP 5 on computer validation and how to transition from GAMP 4 •Auditing GXP computer systems and suppliers
  • 5 Request Info

    Webinar on The Healthcare Quality Improvement Act: How to achieve Immunity in Your Peer Review Process

    This webinar will discuss the Health Care Quality Improvement Act (HCQIA) in detail, including the standards that must be met to achieve immunity under the Act. The HCQIA itself will be reviewed, including a detailed look at the Congressional purpose for the Act. 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/QUALITY-IMPROVEMENT-ACT-501225/FEB-2016-ES-TRAININGREGISTRY
  • 6 Request Info

    Webinar on Supplier Audits: A Critical Quality System Requirement

    This training will look at the regulatory requirements for performing supplier audits and what to look for when performing the initial audit to determine capabilities and quality practices employed. Topics will include how to classify suppliers based on what is purchased, the various types of audits that can be performed (on-site, questionnaire, etc.) a checklist of areas to evaluate during an audit and the follow-up to issues that are found deficient. 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/SUPPLIER-AUDITS-501246/JAN-2016-ES-TRAININGREGISTRY
  • 7 Request Info

    Webinar on How to go Paperless in an FDA-Regulated Environment using Electronic Workflow Signature Approvals and Electronic Records

    This course is intended to provide specific guidelines for coaching attendees in the concepts of 21 CFR Part 11, namely the FDA requirements for using electronic records and electronic signatures (ER/ES), and the best practices for implementing these technologies in a regulated environment. The use of electronic records and signatures enables a company to conduct business in a paperless environment. 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/FDA-COMPLIANCE-501216/JAN-2016-ES-TRAININGREGISTRY
  • 8 Request Info

    Webinar on Keys to Maintaining Objectivity and Independence

    This session is designed to share key concepts that all compliance professionals should employ to ensure their work can be represented as independent, objective and ultimately provide the greatest risk mitigation to their companies. 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/WORKPLACE-LAWS-501239/JAN-2016-ES-TRAININGREGISTRY
  • 9 Request Info

    Webinar on FDA vs EU Inspections - Getting Prepared and What are Differences

    This training is a comparative look at FDA & EU regulations to help attendees understand the FDA and EU inspection process and how to prepare for both of them. Attendees will learn the best practices to respond to Form 483 citations, Warning Letters and EU inspection findings. 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/FDA-vs-EU-INSPECTION-501232/JAN-2016-ES-TRAININGREGISTRY
  • 10 Request Info

    Webinar on Quality Oversight of Pharmaceutical Contract Manufacturing Organizations

    If you use pharmaceutical Contract Manufacturing Organizations (CMOs), your company has ultimate responsibility and accountability for product quality, safety, and efficacy; as well as cGMP compliance. Furthermore, FDA has stated that organizations using CMOs will be held accountable for CMO compliance to cGMPs, as well as CMO adherence to the contracting firm’s regulatory commitments. Therefore, issues identified at your CMO may result in FDA 483s and/or Warning Letters issued to your company. In other words, you cannot just outsource operations and forget about it. 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/CONTRACT-MANUFACTURING-ORGANIZATIONS-501182/JAN-2016-ES-TRAININGREGISTRY
  • 11 Request Info

    Webinar on Implementing a Change Control Quality System Successfully

    This web training session is designed to help attendees understand the fundamental change control steps and processes. The expert trainer will focus on change proposals, assessments, execution and final implementation of a change control quality system. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will also be discussed. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/QUALITY-SYSTEM-501203/JAN-2016-ES-TRAININGREGISTRY
  • 12 Request Info

    Modern Approaches to Process Validation: Requirements for Process Design, Design of Facilities and the Qualification of Equipment and Utilities

    Companies face many common issues and confusion when creating or revamping their validation programs. Some of these common issues are: • Company has expertise in its process validation program but can never quite get is arms around the facility and equipment changes that require never ending equipment qualification (IQ, OQ, PQ), • Customer or 483 audit findings require the company to deviate from its own validation program to meet the needs of the FDA or the customer • For systems that employ software and hardware, how does the company manage the validation activities (i.e. through the software validation effort or through the equipment qualification program? Well, the answers to these and many, many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build (or rebuild) a sustainable validation program.
  • 13 Request Info

    Statistical Sampling Plans - Methods and Applications at San Francisco, CA

    Overview: Many companies use acceptance sampling as a standard business practice. The most common applications use attribute sampling based on ANSI/ASQ Z1.4 and Zero Acceptance Number Sampling Plans by Nicholas L. Squeglia. These common methods are not always the best approaches. This seminar will expose to you to a variety of methods and help you understand when to use them. While many of the examples come from medical device manufacturing because of the rigid regulatory structure, the methods apply in aviation, defense, and other manufacturing settings. This unique hands-on course provides attendees with a solid understanding of acceptance sampling methods and their application to manufacturing. The course delivers tools, templates, and insight that will allow participants to choose and implement the best sampling methods for their application.
  • 14 Request Info

    ISO/IEC 17025:2005 and Laboratory Accreditation

    QMS is the catch phrase for accreditation and is the backbone of ISO/IEC Standard 17025:2005. The Quality System Manual (QSM) is the bible in a QMS environment because, much like its predecessor, Good Laboratory Practice (GLP), it contains the policies that the laboratory is expected to follow to achieve quality results. It is in fact only the "what to do" component of a QMS. What is also needed are the "how to do it" or procedures and methods and finally the controls or evidence that it was done properly.
  • 15 Request Info

    Risk Analysis and Design of Experiments in Process Validation and Development

    The use of DOE methodology provides a means to identify process parameters which impact product quality (critical process parameters) and determine the functional relationship that links the process parameters to that critical quality attributes. Screening designs, such as 2k factorial and D-optimal designs are used to determine critical process parameters. Response surface designs, such as Central Composite Designs (CCDs) and I-optimal designs are used to model the functional relationship between those critical process parameters and the critical quality attributes. 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;
  • 16 Request Info

    Risk Analysis and Design of Experiments in Process Validation and Development

    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.
  • 17 Request Info

    Advanced Tools and Techniques for Data Analysis

    This 2-day advanced analytics seminar will introduce you to predictive analytics techniques, so you can frame strategic and operational questions involving marketing, finance, and operations or other real-world business applications.

    In this hands-on course, you will cover a variety of analytics tools, such as histograms, ANOVA analysis, A/B testing, Pareto analysis, clustering, box plots, scatter diagrams, partitioning, unstructured text analysis, and multivariate regression analysis. Best of all, no background in statistics or programming is required. As long as you have a basic understanding of spreadsheets, you will learn how to manipulate complex data sets so you can gain insights that are not possible with common business intelligence techniques.

  • 18 Request Info

    Verification vs. Validation in Regulated Industries by John Chapman

    Areas Covered in the Webinar: Verification & validation types. Definitions. Design control. Process control. Application. Consequences of poor verification & validation. Why verification & validation makes good business sense?
  • 19 Request Info

    Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency by Dr. Harvey Rudolph, HRRM, LLC (Ex-FDA Official, ISO 14971 S

    Learning Objectives: To educate attendees on the vital reasons for risk management and the key role it plays in the product life cycle To demonstrate the requirements of ISO 14971, how they reflect FDA concerns To clarify how risk management impacts international standards, such as IEC 60601, and how to conform to risk management requirements To provide practical application experience and skills in the process and tools of risk management, enabling attendees to be effective risk managers To teach how to establish a quantitative risk management system and one that complies with EN/ISO 14971:2012 To provide attendees with the Dos and Don'ts for an effective and efficient risk management system.
  • 20 Request Info

    Analytical Instrument Qualification and System Validation Dr. Ludwig Huber, Director and Chief Editor, LabCompliance

    Learning Objectives: Learn about the regulatory background and requirements for laboratory instrument qualification and system validation Understand the logic and principles of instrument qualification and system validation from validation planning to reporting Understand and be able to explain your company’s qualification and validation strategies Be able to independently prepare execute test protocols, this includes setting specifications and acceptance criteria Understand how to review and approve qualification and validation protocols Be able to develop inspection ready qualification and validation deliverables Learn how to avoid and/or respond to FDA inspectional observations and warning letters.