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  • 41 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
  • 42 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
  • 43 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.
  • 44 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.
  • 45 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.
  • 46 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.
  • 47 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
  • 48 Request Info

    PREDICT Software Screening Prior to Entry [Harmonized Tariff Schedule]

    Overview: The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry.
  • 49 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.
  • 50 Request Info

    Investigation and Root Cause Analysis to Meet FDA Expectations

    Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system. It is required in resolving verification and validation issues including data outliers that frequently but are often improperly dismissed arbitrarily. It is required in order to "close-the-loop" on corrective and/or preventive actions (CAPA), and do proper impact analysis / actions. Such failure investigation and root cause analysis is a major element of cGMP compliance.
  • 51 Request Info

    What every Manager Needs to Know about Governance, Risk and Control

    This function is often given to outside consultants that may not understand your organization and try to fit you into a cookie cutter vendor model. You need to really understand that this is more than a form or checklist. Otherwise you may be missing great opportunities to add value and de-risk your organization.
  • 52 Request Info

    Packaging and Labeling in Pharmaceutical Production :2-Day In-Person Seminar

    Pharmaceutical and life sciences companies are under an extreme amount of pressure to maintain an ever-increasing amount of regulation and legislation. With this pressure, they still need to increase efficiencies, bring new products to the market faster, reduce prices, deliver innovation, ensure patient compliance, and maintain business compliance.
  • 53 Request Info

    PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation

    The European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine its effectiveness. It includes audit of the pharmacovigilance system which is covered by the quality system. The GVP Modules are applicable to EU-based companies and any company marketing medicinal products on a global basis. The legally required risk based audit strategy shall cover all PV processes and tasks undertaken by or delegated to other departments, MAH affiliates, and third parties such as distributors, external service providers, partners (the PV Universe). The PV Audit Strategy Plan is used to prepare the PV audit program, i.e. annual PV Audit Schedule.
  • 54 Request Info

    The Proper Way to Correct I9 Documents and Not Pay Penalties

    On June 30, 2016, the Department of Justice (DOJ) along with the Department of Homeland Security (DHS) have issued several rulings outlining several civil penalties increases, ranging from small hikes to doubling penalties. Not only does this ruling impact all immigration processes but it will impact the number of fines and penalties that employers must pay if they are audited for I9 documentation and impact most immigration processes and regulations. Learn the precise way to correct I9 documents to stay away from non-compliance and penalties.
  • 55 Request Info

    6-Hour Virtual Seminar on Transition from Peer to Supervisor

    Today's workforce is experiencing high turnover and disengaged employees. It is a known fact that employees quit managers- to avoid turnover it is critical to have the appropriate skills to retain employees. Transition from a Peer to Supervisor can be very difficult for most newly promoted supervisors. Many are not equip with the tools to successfully transition. This seminar will equip newly promoted supervisor with tools and techniques to decrease turnover, increase employee engagement and increase employee productivity.
  • 56 Request Info

    6-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices

    If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other.
  • 57 Request Info

    Webinar on How to Prepare for FDA Inspections and Customer Audits of Pharmaceuticals

    Learn how to prepare for an FDA inspection and how to behave during one by attending this webinar by Dr. Loren Gelber. Register 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/How-to-Prepare-for-FDA-Inspections-and-Customer-Audits-of-Pharmaceuticals-505331/May-2019-ES-TRAININGREGISTRY
  • 58 Request Info

    Webinar on Steam Sterilization Microbiology - Autoclave Sterilization Process

    Learn about steam sterilization microbiology and how to develop a successful autoclave sterilization process. Register for the webinar 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/Steam-Sterilization-Microbiology-and-Autoclave-Performance-Qualification-509267/May-2019-ES-TRAININGREGISTRY
  • 59 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.
  • 60 Request Info

    Updated CE Marking Process & ISO 13485:2016 Expectations

    After completion of this course, attendees will have enhanced knowledge of the ever-changing landscape of Medical Device Regulation in the EU, Also The content of this course is designed to simplify the understanding of requirements and to provide attendees with the latest insight on how changes are being viewed and implemented by companies marketing products in the EU.