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Courses

  • 41 Request Info

    Theory and Practice of Near-Infrared Spectroscopy

    Overview: NIR is more complex than typical spectroscopic methods. This webinar will compare and contrast NIRS with “commonly used” spectrometers, now in use and more familiar to analysts. Why should you Attend: These can be hand-held, lab-based, or installed in process lines This webinar will explain the manner in which NIR works, the equipment available, and the applications where it may best be used. After this webinar, you will be able to evaluate which type of NIR would be best for your application
  • 42 Request Info

    What is Human Factors and why is it Important?

    Overview: This webinar provides a fundamental level appreciation of human factors and how it has been implemented within the engineering discipline to improve design and operation to support system goals. Why should you Attend: Understand the definition and scope of human factors Recognize the benefits of user centred design Identify opportunities where HF may improve current processes and designs Discuss the regulatory environment in several jurisdictions
  • 43 Request Info

    3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion

    Overview: FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA. Trolling for off-label information in social media, scrutiny of educational material under "safe harbor" and apparent conflicts of interest at a public event create a sink hole for firms even though it may seem innocent in your eyes.
  • 44 Request Info

    You can do a Lot More than you Think

    This course offers practical approaches for supervision on the floor, strategies to get your group in sync and approach issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues, Also we will discuss why supervision is so important in reducing and preventing human error, And also you will learn how to measure human error rates at your department and keep track of metrics.
  • 45 Request Info

    Things To Do Immediately About Master Validation Plan 2019

    FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.
  • 46 Request Info

    What Good Documentation Practices [Experts] Don't Want You To Know

    In this webinar speaker will explain How to write or record information in a compliant way (includes text, numbers, electronic signatures etc), In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.
  • 47 Request Info

    Sample Size Determination for Design Validation Activities

    Overview: Statistical Methods are typically used to ensure that product performance, quality, and reliability requirements are met during the Design Validation phase of product development. This webinar discusses common elements of sample size determination and several specific sample size applications for various design validation activities including Reliability Demonstration/Estimation, Acceptance Sampling, and Hypothesis Testing.
  • 48 Request Info

    Project Management for Non-Project Managers

    This Project management training will provide you with a solid foundation for managing that first project or to simply sharpen existing project management skills, It is not just important to learn about project management - project management has its own body of knowledge, Also The webinar is designed to build a working understanding of the subject and for a quick start-up for those unanticipated project management assignments.
  • 49 Request Info

    Understanding the Impacts and (Applications) in the Logistics Industry

    Overview: The logistics industry is huge, worldwide and critical to our global economy. The industry consists of transportation, warehousing, logistics and technology companies that move goods (physical assets) from producers to consumers. The industry has grown rapidly in size and sophistication as supply chains became bigger and more demanding. Block chain is one of the technologies that may provide the next advancement in connectivity, speed, transparency, security, productivity and cost savings for the logistics industry.
  • 50 Request Info

    Controlling Human Error in the Manufacturing Floor

    Overview: Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences. To work with these challenges it is really important to understand human behavior and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed. This course offers practical approaches and models to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.
  • 51 Request Info

    Travel and Entertainment Expenses: Expense Reimbursement Fraud

    Overview: This training program will address why internal controls over travel and entertainment (T&E) expenditures are a critical component of the control environment. Although the topic of travel and entertainment abuse is not one that management likes to address, it is a very important indicator of the adequacy of a company's control environment.
  • 52 Request Info

    PMDA Look for When Conducting cGMP Regulatory Inspections

    Overview: This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.. After this event, you will be fully prepared for cGMP regulatory inspections in those countries.
  • 53 Request Info

    Assay Validation According to CLSI Guidelines 2018

    Overview: Bioassay development and validation is very critical in pre-clinical drug discovery, clinical biomarker and translational research, diagnostic product (including companion diagnostic) development. In this presentation, overview if given for the terminologies, the scientific principles, and the regulatory guidelines that are related to assay validation. Then each of the assay performance characteristics (specificity, sensitivity, accuracy, precision, linearity, stability, reportable range, reference range) will be explained in terms of experimental design and statistical analysis.
  • 54 Request Info

    European Privacy Regulation what and how in 2018

    Overview: The GDPR (General Data Protection Regulation) compels companies that process Personally Identifiable Information (PII) of European citizens to demonstrate their insight in all PII processing in their business. After assessment by a Data Protection Officer (DPO), they should implement appropriate organizational and technical controls.
  • 55 Request Info

    That your Supplier can meet all your Expectations

    Overview: This training program will provide participants with a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier can meet all your expectations. When contemplating the use of a supplier you would normally have many requirements and expectations that must be met. These include technical, regulatory, quality, responsiveness, location, readiness, and those less defined but critical. One of the tools at your disposal to verify the supplier’s acceptability is to audit the operation.
  • 56 Request Info

    When to Submit a 510(k) for a Change to an Existing Device

    Overview: This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (i.e., "existing devices") during the process of deciding whether the modification exceeds the regulatory threshold of 21 CFR 807.81(a)(3) for submission and clearance of a new 510(k).
  • 57 Request Info

    Essentials of Validation - IQ, OQ, PQ

    Overview: Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements 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.
  • 58 Request Info

    3-Hour Virtual Seminar - Good Pharmacovigilance Practice

    Refund Policy This course aims to provide basic training for those concerned with pharmacovigilance, This course has been planned to provide you with the essential skills and tools to prepare and host a regulatory inspection and to facilitate the response and follow-up to the inspection outcome, findings (483s) and the necessary Corrective Actions and Preventive Actions (CAPA).
  • 59 Request Info

    Validation of Laboratory and Process Analysis Instrumentation

    Overview: How to choose/make standards: Lab-based standards are most often synthetic, with final forms tested for extraction of all the analyte Process samples are most often final product, scanned spectroscopically, then analyzed via a referee method. Process stds may be made synthetically, but several precautions need to be taken.
  • 60 Request Info

    European Data Protection Regulation - 2018 Implementation

    Overview: On 4 May 2016, the official texts of the Regulation and the Directive have been published in the EU Official Journal in all the official languages. While the Regulation will enter into force on 24 May 2016, it shall apply from 25 May 2018. The Directive enters into force on 5 May 2016 and EU Member States have to transpose it into their national law by 6 May 2018.