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Courses

  • 21 Request Info

    Project Management for FDA-Regulated Companies

    This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale.
  • 22 Request Info

    Risk Management in Medical Device Design

    Overview: The webinar will explore the basic principles of risk management and planning as they relate to medical device design and as required by the FDA. It will present a logical process for risk management from risk identification through evaluation/rating and mitigation. Why should you Attend: The secret to preventing medical device recalls or at least to minimizing their impact is sound Risk/Hazard Analysis. Aside from being required, it is absolutely essential and necessary to the development and fielding of medical devices that offer a significant level of protection for patients and manufacturers alike.
  • 23 Request Info

    Accelerated Aging Techniques for Medical Device Packaging

    Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods. AA is used to estimate the useful lifespan of a product or its shelf life when actual lifespan data is unavailable. The ability of product designers to accurately predict changes in polymer properties is of critical importance to the medical device, consumer, and industrial markets.
  • 24 Request Info

    Verification vs Validation-Product, Process or Equipment and QMS Software

    The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.
  • 25 Request Info

    Skills and Competencies Needed to Succeed in Today's Workplace

    What critical thinking means Why it's important How it relates to you in the workforce How better thinking skills can help you How you can learn to think critically to make decisions and set goals To examine the fundamentals of critical thinking, problem solving, decision making and goal setting To explore the relationship between critical thinking and career self assessment To help participants make informed and wise decisions To help participants approach problem solving and decisions making effectively
  • 26 Request Info

    Industry Best Practices for a Learning Culture

    The first is the ability to design the organization to match the intended or desired outcomes, and second, the ability to recognize when the initial direction of the organization is different from the desired outcome and follow the necessary steps to correct this mismatch. Organizations that are able to do this are exemplary.
  • 27 Request Info

    Handling Sensitive Dress Code Issues without Getting Sued

    Communicating and enforcing dress code policies are essential. Learning to set and manage policies by working directly with internal managers, business partners and executives in handling issues such as inappropriate or provocative dress, unhygienic employees is important, as well as identify and mitigating any legal issues.
  • 28 Request Info

    Webinar on Root Cause Analysis in the Laboratory to Determine Non-Conformance

    Learn to determine what why and how of non conformances occurring in the laboratory. Register now. 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/Root-Cause-Analysis-RCA-in-the-Laboratory-Addressing-Non-Conformances-509217/JULY-2019-ES-TRAININGREGISTRY
  • 29 Request Info

    Webinar on How to Identify Toxic Impurities in Drug Products

    You will learn how to identify and analyse toxic impurities in drug products from active pharmaceutical ingredients. 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/Toxic-Impurities-in-Active-Pharmaceutical-Ingredients-506938/JULY-2019-ES-TRAININGREGISTRY
  • 30 Request Info

    Webinar on Simplified CAPA Process - 21 CFR Subpart J of FDA Regulations

    Learn 21 CFR subpart J of FDA regulations related to CAPA, how to integrate CAPA with other branches of QMS. Register today for this webinar. 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/CAPA-Simplified-A-One-Form-Easy-To-Complete-Method-for-Simplifying-Your-CAPA-Process-505214/JULY-2019-ES-TRAININGREGISTRY
  • 31 Request Info

    Webinar on Hazard Analysis Following ISO 14971- Risk Management

    In this webinar we will explain in detail the process of conducting a hazard analysis and how to integrate hazard analysis into the design program. Join today. 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/Hazard-Analysis-Following-ISO-14971-509891/JULY-2019-ES-TRAININGREGISTRY
  • 32 Request Info

    Webinar on How to Prepare for and Manage FDA Inspections

    Attend this webinar to learn how to prepare for an FDA inspection, process of the inspection, roles assigned for these inspections and more. 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/Best-Practices-for-Preparation-for-Behavior-during-and-Response-to-an-FDA-Inspection-502816/JULY-2019-ES-TRAININGREGISTRY
  • 33 Request Info

    Webinar on Preventing Human Error in the Life Sciences

    Explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance. 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/Preventing-Human-Error-in-the-Life-Sciences-509812/JULY-2019-ES-TRAININGREGISTRY
  • 34 Request Info

    Method Development and Validation for Assays Supporting Testing of Biologics:2-Day In-Person Seminar

    Learning Objectives: Understanding the different requirements for small versus large molecules Mapping appropriate timelines with decision points Designing, developing, optimizing, and validating key methods Potency methods, other release and stability methods Preclinical and clinical methods Use of DOE and statistical analysis Handling of critical materials Process monitoring concepts Assessment of orthogonal methods Assessing readiness for validation Defining the validation protocol with real-time capture of data analysis Maintaining quality through documentation Who will Benefit: Below titles working in biopharmaceuticals, pharmaceuticals, natural products/botanicals will be benefited by attending this seminar: Validation Scientists QA/QC Regulatory Affairs Laboratory Managers Assay Development Specialists Statistician CMC Titles Bio Assay
  • 35 Request Info

    Risk Management in Medical Devices Industry:2-Day In-Person Seminar

    Risk management is a mandatory and necessary process during the entire device life. Not only will it help to design and maintain devices efficiently, but it also ensures that the device will be as safe as possible and prevents harms to patients, users, and the environment. Like any process that tries to produce repeatable and consistent results, the risk management process must be clearly understood, including the strengths but also the limitations. By attending this seminar you will learn the main elements of ISO 14971, ISO 13485, IEC62304, IEC62366-1/-2, risk management life cycle steps and benefits, and FDA software reviewers' guidance.
  • 36 Request Info

    FDA Audit, Quality Assurance Practices, Responsibilities and Expectations:2 days in-person Seminar

    It is no surprise to anyone who reviews regulatory citations to notice the number of deficiencies cited that are associated with quality systems. Today, the basis for all FDA audits both within the US and internationally is based on the quality systems approach and the six systems that comprise it. Whether the audit is a full or partial audit, the quality system within a company will always be inspected and this seminar will help review what are the expectations and the common areas to be familiar with. As a basis for regulatory audits, the quality system, its procedures and their implementation are reviewed to help verify the level of effectiveness in assuring consistent control and quality of materials, components and final product.
  • 37 Request Info

    Identify and Manage Data Integrity Issues, CSV and 21 CFR Part 11:2-Day In-Person Seminar

    The FDA and other Health Authorities worldwide have focused their attention on data integrity, considering data integrity to be a significant risk to public safety. This is evident in the number of Warning Letter observations and related Import Alerts issued in the last 5-7 years. Data integrity is not a new topic, however, but is a part of the GMPs. Often, companies attempt to address data integrity issues procedurally and by conducting numerous training programs. These tend to be ineffective as data integrity issues are often rooted in a company's culture and may be very difficult to address.
  • 38 Request Info

    Managing Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Inspection

    Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.
  • 39 Request Info

    Implementing UDI (Unique Device Identification) - Plan Now for Success:One Day In-Person Seminar

    The one-day workshop provides the information you need to implement UDI. An effective implementation gives your customers the information they need. It will also help you avoid an FDA 483 and a Warning Letter. The workshop gives you hands on experience to understand UDI and your device. You bring a laptop computer and some information about your device. During the seminar you receive toolkits to determine the compliance dates, packaging configurations, and the attributes you will load to GUDID
  • 40 Request Info

    Software Validation for Medical Instrument Development [Introduction]

    Overview: This is an introduction to software validation for medical device development targeted to software developers, engineers, testers and managers. It covers simple and small projects to mid-size projects including development projects and manufacturing projects. It will be useful for new hires in any of these functions and for persons assigned to audit the validation results. Why should you Attend: There are several key elements that need to be included in your instrument Validation and Verification efforts to ensure compliance with FDA and EU IVDR (In-Vitro Diagnostics Regulation). The new regulations have added many new requirements that translate to new deliverables your testing report must provide.