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Courses

  • 161 Request Info

    Project Management for Non-Project Managers

    Project management is the art and science of getting results by following a roadmap laid down to turn customers desires into concrete products and services by following established procedures in a defined sequence. The Project Management Institute brought active practitioners together to produce the Project Management Body of Knowledge, PMBOK, which is used around the world on all sorts of projects of varying sizes, with or without software support tools. PMBOK definition: A project is a temporary endeavor undertaken to create a unique product or service. It is temporary because every project has a definite beginning and a definite end. It is Unique because the product or service delivered is different from others. Organizations use projects to achieve their strategic needs, which cannot be attained through normal operational means.
  • 162 Request Info

    Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success

    The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions. Onboarding new or transferred employees in a Pharmaceutical Good Manufacturing Practices (GMP) environment and ensuring compliance with these requirements create some unique challenges. Although FDA expectations provide some of the framework regarding types and frequency of training, there are decisions that the company will need to make in light of its evaluation of how to best achieve compliance for its employees, maintain a quality culture, and manage the work environment.
  • 163 Request Info

    Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

    The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product. The advantages of "confidence/reliability" calculations are explained. Such calculations are demonstrated for Attribute data (pass/fail, yes/no data) as well as for variables data (i.e., measurements). If variables data is "Normally distributed" the calculations are extremely simple. The webinar explains how to handle "non-Normal" data, and provides the methods, formulas, and tools to handle non-normality.
  • 164 Request Info

    EQ and YOU

    Emotional Intelligence is a set of emotional and social skills that establish how well we perceive and express ourselves, develop and maintain social relationships, cope with challenges and engage in life in an effective and meaningful way. Since some of the smartest people I know lack EI (or its measurement on tests EQ) I am sharing several of my observations and experiences with them. One can be brilliant and successful professionally while at the same time struggling to be socially accepted. This course explores several aspects of EI/EQ and offers enough descriptions to enable the listener to self-identify and decide which of the elements needs self-improvement. It is also a useful tool for management in its quest to be as useful as possible to the people who report to them. We explore the different aspects of EQ and how different tests describe and measure them.
  • 165 Request Info

    Utilizing HR Metrics to Illustrate & Improve Human Resource's Contribution

    Human Resource Departments have traditionally been concerned with the processing of transactions and administrative functions - often with little or no objective data to provide them feedback on: The effectiveness of their HR processes Or the contribution that these processes are making to the organization's business strategy However, many senior corporate executives are no longer satisfied with this scenario - they want HR to prove its value and Effectiveness through objective data Human Resources metrics allow HR professionals to: Be seen as business partners who are customer focused, strategic and change oriented Make greater contributions to their business' strategic and operational plans Speak the 'language of business' Gauge whether they are satisfying the needs of their internal customers Make continuous, meaningful improvements to HR processes Show that they are not afraid of measuring their contribution Avoid being outsourced
  • 166 Request Info

    Controlling Human Error in the Manufacturing Floor

    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.
  • 167 Request Info

    Inspiring Leadership through Conflict, Courage, & Creativity: The Art of Passion Power

    In today's diverse, always-on, TNT - Time-Numbers-Technology - Driven & Distracted World, three performance-communication-relationship-building pillars often determine leadership success: Are you courageously developing and passionately projecting your unique energy and experience, strengths and skills? Are you truly "being heard or are you just making noise"? Are you developing mutually productive and innovative partnerships? With the Stress Doc's singular wit and wisdom and Get FIT - FUN-Interactive-Thought-provoking - method, this webinar will strengthen attendees' abilities to bring their own purpose, passion, and power to real work-world issues. You will learn and apply high task & human touch motivational skills and strategies for: high-impact leadership and communication embracing change, loss, and opportunity managing anger and conflict
  • 168 Request Info

    Lean Document Control for Manufacturing in Life Sciences

    Overview This webinar will show you how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements. Why should you Attend Just as a manufacturing process produces a product, controlled documents are the product of a business process. Just as in manufacturing, a product cannot move forward if it is waiting for component parts, a document cannot move forward if it is waiting for information, or if its use is constrained by other documents. Although many life science companies advocate lean manufacturing, lean laboratory, and lean operations, they have cumbersome controlled documents and systems which cause significant operating expenses, and make it difficult to introduce process
  • 169 Request Info

    Quality is not an Organization

    What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company. It can be a culture of excellence and a management philosophy leading to improved customer satisfaction and business success. This webinar will help you understand the various interpretations. We will discuss concepts for creating a culture of quality and management excellence with your company.
  • 170 Request Info

    Microsoft Outlook Tips, Tricks, and Productivity Tools

    This 60 minute Get Organized with Outlook session will encourage and enlightened Outlook users on how to use Microsoft Outlook to more confidently and efficiently organize their information and commitments. Participants will learn smarter tips, tricks and systems to better manage their tasks, follow-ups, contacts, notes and calendar items. Don't worry, this not a boring computer class (you'll have fun!) and you get my no tech-talk guarantee!
  • 171 Request Info

    Operational Risk for Financial Institutions - Beyond Regulatory Constraints

    Most large losses have been due, at least partly, to the occurrence of operational risks. Whilst financial institutions like to show that they know about this type of risks, the profession has been slow to learn from other older industries for which risk management is a critical factor. The banking world has been subject to avoid large debacles due to e.g. rogue trading and unharnessed macroeconomic turbulences. It is now critical for banks to set up robust but flexible comprehensive frameworks to handle these risks at reasonable costs and to the satisfaction of stakeholders, without compromising any legitimate drive to go forward and advance in sophistication.
  • 172 Request Info

    What Employers Need to Know About Severance Arrangements - EEOC, ACA and ERISA

    Many employers think that if they offer severance pay conditioned on certain restrictions that they have eliminated all legal risks, and assume everything is fine-until it's not. For example, do you condition severance pay on promises not to sue and other post-termination restrictions? Did you know that you might be contractually obligated to provide severance pay even if you do not have a written agreement? Did you know that your severance agreement may not protect you as much as you think? Or that it may not be enforceable? Is your severance arrangement subject to ERISA laws? Attend this webinar to learn more.
  • 173 Request Info

    2019 Update on Compliance with the Americans with Disabilities Act (ADA)

    The Americans with Disabilities Act (ADA) was signed into law by George H.W. Bush in July 1990. The Act is a civil rights law that prohibits discrimination against individuals with disabilities in all areas of public life, including jobs, schools, transportation, and all public and private places that are open to the general public. The purpose of the law is to ensure that people with disabilities have the same rights and opportunities similar to those provided to individuals on the basis of race, color, sex, national origin, age, and religion. Disability accommodation is an important and visible aspect of ethical business practices. Compliance with the Americans with Disabilities Act will ensure your organization is operating in an ethical manner.
  • 174 Request Info

    Medical Device Software Per IEC 62304

    This course is essential for Medical Device companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most company's face when submitting their device for approval is finding out after seven or more months of waiting that the 510K has been denied because the software portion of the submittal is inadequate and not compliant. They also face potential audit risk which might prevent them from selling their approved product if they have been found to not have an IEC62304 Compliant Software Quality System. This course will ensure that Device companies will know exactly what documentation needs to be prepared. They will also know how to ensure the documentation is prepared correctly so the software portion of the submittal will be in compliance preventing delays of the 510K approval.
  • 175 Request Info

    FDA's Problem with Software Monsters

    Software's level of complexity and use keeps expanding at exponential levels. Likewise, the potential risks to health and loss of privacy follow suit. Ransomeware attacks hold software programs hostage until you pay the culprit thousands of dollars. Life supporting and life sustaining health software grinds to a halt. Extracting personal healthcare information is another plague that has a huge financial incentive for hackers. Your software is running on thin ice. FDA looks at software based on the risk to health associated with the software's use. Cybersecurity problems for software for life sustain devices, wireless networks for patient manage and home use devices open the gate for cyber intrusion, functional malware and total denial of access denial to an entire network of software, such as that used in hospitals and clinics. Who will help you? This becomes a self-help scenario; FDA and the FBI cannot protect you from the "bad guy."
  • 176 Request Info

    Fishbone Diagramming

    Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability. Specific areas presented: Look for Evidence The Post-it Exercise Pareto Chart Fish Bone Diagramming Process Reliability Modeling Critical Path Analysis Value Stream Mapping Failure Mode Effects Analysis Process Improvement and Problem Solving: Reality Charting Model for Improvement
  • 177 Request Info

    Dietary Supplements CGMPS - 21 CFR 111 Compliance

    21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs. This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record. This webinar will discuss basic Dietary Supplement CGMP of Part 111 and related requirements, to include: Quality Management System / QA / QC Personnel, Facilities, Equipment Software controls Production and Process Controls Holding and Distribution Complaints and Returns Records
  • 178 Request Info

    Medical Devices - Complying With 820.250 Statistical Methods

    Learn how to manage Statistics including establishing a policy along with procedures relative to specific areas of applications. Highlighted are statistical techniques for: Process Validation Design Verification Design Validation Audits and Effectiveness Checks Test Method Validation Manufacturing Acceptance Sampling Plans and Inspections Trending Data Setting Specifications Numerous badly needed advances in the application of statistics have occurred over the last 10-20 years. This are highlighted including: Change-Point Analysis for CAPA Investigations and Trending Normalized I and Laney U charts for complaint trending Equivalency testing instead of t-tests Methods of Validating Attribute and Destruction Test Methods Improved methods for testing for and handling nonnormal data Sampling Plans for precision, accuracy, and homogeneity
  • 179 Request Info

    BREXIT - What's Changing for Life Science Product License Holders-Manufacturers and What you Need to do Right Now

    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. Marketing Authorization holders of centrally authorized or mutually authorized [MRP /DCP] product licenses for pharmaceuticals and biologics along with CE-marked medical devices for human or veterinary use will have legal repercussions when the UK exits the EU.
  • 180 Request Info

    Performing your Annual HIPAA Security Risk Assessment

    In September of 2017, OCR shared preliminary results of their Phase 2, nation-wide, HIPAA Audits. As it relates to HIPAA Security Risk Analysis and Management the results were pretty shocking. OCR reported that 83% of those they audited had a score of "inadequate" or "failure" on their performance of an information security risk analysis while 94% had a score of "inadequate" or "failure" on their efforts of establishing or maintaining an information security risk management plan. A couple months ago the OCR announced their $3.5 million settlement with Fresenius Medical Care North America (FMCNA). The main reason cited by the OCR was that Fresenius "failed to heed HIPAA’s risk analysis and risk management rules." OCR Director Roger Severino had some very clear and strong words about the importance of performing a HIPAA Security Risk Analysis.