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  • 1 Request Info

    21 CFR Part 11 compliance for software validation and SaaS/Cloud 2017

    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. Today the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements
  • 2 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.

  • 3 Request Info

    Applied Statistics for Business Analytics Applications

    This course is intended for those who need practical skills and knowledge in using statistical tools and techniques for Business Analytics (BA) applications—or so-called “Exploratory Analysis.” The course will emphasize where and when the tools and procedures apply, including the inputs they rely on, as well as the end-results—or outputs—they produce. The tools and techniques will be introduced from the standpoint of their practical utility as well as the outputs they are capable of producing, rather than their mathematical structure or derivation. Hands-on exercises will be used to reinforce learning by taking advantage of the built-in statistical functions in MS Excel.
  • 4 Request Info

    ARC002 - ARC's Planning & Conducting Operational Audits: The Comprehensive Audit

    This is the Real Deal. This hands-on program is for experienced business professionals who want to see their organizational units in a completely new light. The focus on effective and efficient Operational (Process) Audits is more critical now than ever. With individuals challenged with the efficient, effective, and economical use of resources, you need the tools to quickly analyze key business processes to ensure they are providing the expected return.This comprehensive program gives you these tools to evaluate the critical environments of your organization essential for the enhancement of shareholders’ wealth. You’ll learn how to project the impact of proposed changes to the gains in shareholders’ wealth, determine the best use of limited funds, identify cash leakages, and much more.
  • 5 Request Info

    Auditing and Inspecting Preclinical Research for GLP Compliance

    The Good Laboratory Practice (GLP) guidelines have progressed through various transitional phases to become guidelines in some countries and regulatory/statutory instruments in others. The objective of the GLPs is to ensure that a standard approach is undertaken, covering traceability and accountability of medical research and drug development process. This webinar discusses various aspects of auditing and inspecting preclinical research compliance with GLP. 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/Auditing-and-Inspecting-Preclinical-Research-for-GLP-Compliance-503774/DECEMBER-2017-ES-TRAININGREGISTRY
  • 6 Request Info

    Biotech/Biosimilar Products: Current and Emerging Analytical CMC Expectations

    Learning Objectives: Recognize the system of worldwide regulatory guidance applicable to biotech and biosimilar product CMC requirements Understand why requirements for biotech products are so different from those of chemical products Find exactly ‘where it is written’ for current and emerging CMC expectations for biotech/biosimilar products, and get copies of those regulatory documents See how to implement a staged approach to establishing specifications for release and stability testing Learn the current analytical technologies used for establishing biotech/biosimilar product characteristics and assessing comparability Select the appropriate methods for release and stability testing Design suitable qualification and validation exercises for method intended uses Establish stage-appropriate ICH stability protocols Learn the tiered approach for managing product reference standards Recognize how much R&D data are exposed to regulatory scrutiny
  • 7 Request Info

    Case Management's Role in Managing Third Party Payer Denials

    Case management, as a member of the revenue cycle team, plays a strategic role in the implementation of strategies aimed at reducing and/or preventing third party payer denials. Reducing and preventing denials requires proactive and hard-wired processes that engage the entire interdisciplinary care team. The causes of denials are complex and therefore require complex solutions. This program will review the causes of denials and key strategies for reducing and preventing them. Solutions will include key members of the interdisciplinary care team including physicians, physician advisors, case management leaders and case managers. Strategies for analyzing your denial rate will also be included. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Case-Management-s-Role-in-Managing-Third-Party-Payer-Denials-504198/DECEMBER-2017-ES-TRAININGREGISTRY
  • 8 Request Info

    Cleaning Validations Using Extraction Techniques

    Cleaning validations are an essential step in the medical device development process. One of the most common methods is using extraction techniques to validate the cleanliness of a device. This webinar will provide valuable guidance on how to achieve a thorough validation of a cleaning process. These cleaning processes may include initial cleaning validations, in process cleaning validations, or reprocess cleaning validations.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/Cleaning-Validations-Using-Extraction-Techniques-507793/DECEMBER-2017-ES-TRAININGREGISTRY
  • 9 Request Info

    Collaboration 4 Project Results

    High energy, interactive 3-day PMBOK-based course for Proj.Mgrs. Teaches processes/ techniques for shaping, energizing, motivating project teams to get faster/better results with Collaboration,“The Tenth Knowledge Area.Bob Moir 404.338.0715
  • 10 Request Info

    Complaints, Adverse Event Reporting, and Recalls - An Integrated Approach 2017

    Medical Device manufacturers operate in numerous regulatory systems that often have different requirements and are not always consistent. The new ISO 13485:2016 emphasizes this problem. Manufacturers must identify their roles, identify the regulatory requirements for that role, and incorporate them into the quality management system. The various jurisdictions, however, deal with post-market device issues in many different ways. The quality management system, QMS, needs three interlocking process: complaint management, adverse event reporting, and recalls. These processes also have supporting QMS processes such as corrective action and design changes. Overarching the QMS processes are the regulatory requirements, usually involving record keeping and reporting. This workshop covers these primary and secondary QMS processes and analyzes them in terms of US, EU, and Canadian regulations.
  • 11 Request Info

    Critical Thinking Challenge (Business Simulation)

  • 12 Request Info

    Customer Satisfaction Measurement

    Link your customer measurement to customer loyalty. Here are the current strategies, methods and tools used by major organizations to measure customer satisfaction!
  • 13 Request Info

    Design of Experiments Strategies | Six Sigma Process

    Join this webinar Design of experiments "DOE" which is a systematic method to determine the relationship between factors affecting a process and the output of that process. 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/Effective-Design-of-Experiments-DOE-Strategies-503955/JULY-2018-ES-TRAININGREGISTRY
  • 14 Request Info

    DESIGNING A PHARMACEUTICAL QUALITY SYSTEM: An in-depth examination of ICH Q10 and the companion documents (ICH Q8, Pharmaceutical Development and ICH

    The Purpose of this Course is to Review ICH Q10, which is a Document developed by the 3 Countries Comprising ICH (Us, Eu, Japan). ICH Q10 is for the Development of a Pharmaceutical Quality System, In Conjunction with the Companion Documents, ICH Q8, Pharmaceutical Development and ICH Q9, Quality Risk Management. In Addition to the Members of ICH (Us, Eu And Japan), Many Other Groups were involved in the Expert Working Committees that were involved in the Development of these Documents, Etc Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901546SEMINAR?trainingregistry-April-2018-SEO
  • 15 Request Info

    Drug dissolution testing and establishing plasma drug levels in humans 2017

    Drug dissolution testing is an essential and critical step for appropriate and efficient product development such as tablet and capsule. A number of approaches are used to conduct dissolution testing using different apparatuses and methods. Making a choice for an appropriate apparatus and method has always been confusing and challenging. This seminar will provide relevant pharmacokinetics and physiological background so that making this choice becomes easier and instinctive. No prior knowledge of pharmacokinetic and/or physiology is required; however, these will be explained in very simple terms to help attendees in selecting or developing a dissolution method. This seminar will describe in detail the theoretical aspect of the drug dissolution testing including method development. Pros and cons of different approaches will be explained in detail.
  • 16 Request Info

    FDA's Latest Regulations for Computer Systems Used in the Tobacco 2017

    The Tobacco Control Act went into effect by FDA on June 22, 2009. Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, but in 2016, the FDA finalized a rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, which extends the FDA's authority to include the regulation of electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (water pipe) tobacco, pipe tobacco and nicotine gels, among others. The rule went into effect on August 8, 2016.
  • 17 Request Info

    FDA's Refuse to Accept Policy - How to Prepare 510 (K) Submission to Avoid the Pitfalls of the Policy

    Learning Objectives Upon completing this course participants will understand: Difference between a traditional, abbreviated and special 510(k) and when to submit each type of 510(k) When to file for a new device, a change in the intended use or a change in the technology of a cleared device What is contained in a traditional, abbreviated and special 510(k) submission package The submission package, user fees and making an eCopy What is substantial equivalence and what’s required to show substantial equivalence What’s required on the labeling and IFU Which performance tests should be conducted and how to present the data to the FDA The requirements for a risk management plan and report Understand the FDA’s Refuse to Accept Policy What is required in a submission for software controlled devices How and when to use third party reviews When clinical data may be required.
  • 18 Request Info

    Fundamentals of Safety Engineering for Medical Devices

    Understanding the fundamentals of safety engineering for medical devices can make a tremendous difference in saving lives and help companies avoid costs of recall. 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/Safety-Engineering-Fundamentals-for-Medical-Devices-508813/JULY-2018-ES-TRAININGREGISTRY
  • 19 Request Info

    GMP Requirements for Validation and Re-Validation of Analytical Procedures by Kim Huynh-Ba

    Upon completion of this session, attendees will understand cGMP and ICH validation requirements for analytical procedures and learn key factors that would affect validation process of analytical procedures. It will help scientists develop process for evaluation method validation, review changes, and determine when re-validation would need to take place. It will discuss observations and infractions related to method validation.
  • 20 Request Info

    Guidance on Inactive Ingredients- FDA Update

    Attend this webinar to gain an appreciation of the regulatory CMC and use of inactive ingredients manufactured from various firms. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Discussion-Regarding-the-Substitution-of-a-New-Inactive-Ingredient-in-an-Approved-Parenteral-Drug-Product-505414/JULY-2018-ES-TRAININGREGISTRY