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Courses

  • 1 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.
  • 2 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.
  • 3 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.
  • 4 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.
  • 5 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.
  • 6 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.
  • 7 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.
  • 8 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.
  • 9 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.
  • 10 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).
  • 11 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.
  • 12 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).
  • 13 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.
  • 14 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.
  • 15 Request Info

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

    Overview: 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.
  • 16 Request Info

    3-Hour Virtual Seminar on Data Integrity - FDA's Latest Thinking

    Overview: This webinar will give you the tools that you need to ensure that you understand data integrity issues and best practices for ensuring data integrity at your company. Why should you Attend: The FDA is increasingly focusing on data integrity issues, including data manipulation, when conducting facility inspections. Concerns over data integrity issues have resulted in the agency adding companies to the for-cause inspection list, and the FDA has found questionable data during in a significant number of these for-cause inspections. The FDA is noticing some electronic data manipulation in parts of its inspection program and is focusing on training its investigators to be more alert to data manipulation, Branding said.
  • 17 Request Info

    Managing and Controlling the Project - Project Management

    The subject of this webinar is building the project team, The key to achieving success with your project is the people you assign to it, how well you develop the team, and sustaining team member's ongoing commitment to the successful completion of the project, Also you will learn This process includes developing team and individual team member goals, determining the team's operating processes, and building strong team member relationships.
  • 18 Request Info

    Reducing Training Related Errors (Human Error Trainings)

    This course will provide insights into current knowledge of human error and how it can be reduced, The course will provide hands-on experience of practical error reduction techniques, using real-life case studies, You will also gain an understanding of the underlying causes of human error and how to reduce its occurrence by changing the culture of the organization and changing the design of the processes.
  • 19 Request Info

    Computer System Validation 2018 Fundamentals

    This session will address the specific way of documenting your computer system validation work to ensure it meets FDA requirements and can pass an inspection, also this webinar will help you understand the FDA's requirements for good documentation, including how to handle change control and the importance of audit trails, you will learn how to create and maintain good documentation that meets FDA compliance standards.
  • 20 Request Info

    What's Changing for Life Science Product License Holders (BREXIT)

    Overview: The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union. This means that unless a withdrawal agreement establishes another date, all EU primary and secondary Laws cease to apply to the UK from 30 March 2019 going forward. The UK, by definition would become a "third country". Preparing for the withdrawal doesn't just involve the Healthcare Authorities, but every manufacturer and /or license holder of a pharmaceutical, biologic, medical device or combination product in the UK and EU.