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Courses

  • 81 Request Info

    Learning Management Systems (LMS)

    This course will describe the development of job position curricula in the pharmaceutical industry using a Learning Management System (LMS) and provide you with the tools needed to create effective curricula. A Pharma curriculum is the sum total of all the courses that an employee in a specific position requires, and is composed of smaller groups of courses called modules. A curriculum typically will include a "core curriculum" (usually several modules) with all the required courses for all employees involved in GMP functions, a "job-specific" group of courses for the position, modules reflecting further subdivision of responsibilities within individual positions, roles in validated computer systems such as investigations, and roles in applicable hard-copy review processes.
  • 82 Request Info

    SOP Writing, Training and Compliance in the Pharmaceutical Industry

    Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform, and are a vital component of ensuring compliance with regulatory agency requirements for pharmaceutical manufacturing. Pharmaceutical employees often do not realize that by putting their processes in writing, they are making commitments to regulatory agencies. To achieve the goal of an SOP that has adequate but not excessive detail, the course will define the parameters of an effective SOP and provide a solid foundation that will have a positive impact on training and job performance. Conversely, the negative impact of poorly written procedures on production and compliance will also be explored.
  • 83 Request Info

    Japan Regulatory Compliance Requirements for Life Science Products

    This 2-Day seminar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.
  • 84 Request Info

    Leadership Management Academy 201-202: Rising Through the Management Ranks

    Why Should You Attend? By attending, you will take advantage of a great opportunity to advance as a manager to the next level! Too often, we focus on getting things done and results and miss working on our self-development. Let's face it: this is how we get paid yet this is also how we keep falling behind when it comes to our careers. It's time to get ahead! Don't miss an opportunity to advance as a manager again! We'll take you through peer discussions addressing leading and managing, integrating finance and quality, managing your time effectively, managing performance and managing up.
  • 85 Request Info

    The Next Level of Private Practice - Risk, Referrals, Retention & Resilience

    The Next Level of Private Practice journeys into practice development expert Howard Baumgarten's trademark "four R's." These R's include Risk, Referrals, Retention, and Resilience. Each of these four areas possesses specific meaning to the practice owner; meaning that is both general as well as highly specialized and unique to each healthcare practice. As this 2-day training commences, the four R's are introduced and explained in general terms, along with a discussion of how this highly successful business development process came into existence.
  • 86 Request Info

    Uncovering and Managing Successful Post Market Compliance for Medical Devices

    Customer satisfaction plays a significant role in measuring a product's postmarket performance. It is an indicator of how effective the product performance is managed. Both the quality system regulation (QSR) and the International Organization for Standardization (ISO) require procedures and processes to monitor and control your post market problems. The complaint-handling mechanism not only collects feedback from unsatisfied customers, but also provides means for failure investigations and subsequent corrective and preventive actions (CAPA).
  • 87 Request Info

    HIPAA 2018 - Staying Competitive and Complying with HIPAA

    In today's competitive business climate, health care organizations and their business associates should be able to focus on growing their businesses and not worrying about HIPAA Compliance. Staying up to date on the newest health care information and acquiring new patients takes time. HIPAA compliance takes time. But both goals can be accomplished - in fact, a good compliance program can make you even more competitive because compliance helps protect and grow your business and sets you apart from your competitors. For example, knowing how to use social media and electronic communications within HIPAA rules is key to staying competitive. Also, managing risks is critical to reducing exposure from breaches or cybercrime.
  • 88 Request Info

    A Leader Is...™

    New Microlearning Video Program! Being a leader is much more than directing others. This short, yet powerful video sums up the key qualities of being an effective leader within any organization. A leader is someone who... Shows respect... to everyone. Is a role model. Offers assistance when needed. Shows support for others during challenging times. Actively listens when others are speaking. Is willing to have the hard conversations when needed. Supports ideas other than their own. Mentors others. Stands up as an ally. About A Leader Is...™: This thought-provoking, powerful short video uses impactful imagery, video and music to inform and encourage discussion on being an effective, passionate and inclusive leader within your group, team or organization. Training Materials Included: Discussion Guide
  • 89 Request Info

    Diversity 101™ - The Complete Series

    Treating others with respect is paramount to a successful and inclusive workplace. Things like unconscious/hidden bias, gender identification, crude jokes, disrespectful comments, etc. can all stress an organization not prepared for the diversity we are seeing in today’s workforce. This new series takes a fun, creative approach to describing the core components of diversity, inclusion and respect in the workplace. It features 8 dramatic, thought-provoking vignettes that entertain while they tackle deep diversity, inclusion and respect topics. As organizations and customer bases become increasingly diverse, it is important for employees to be able to engage and work through differences in a positive manner that supports productivity, teamwork and customer satisfaction. Topics covered in this new series include: unconscious (hidden) bias, cultural competence, diversity moments, gender & gender identity, rumors & gossip, joking and improper expressions.
  • 90 Request Info

    Civility Is...™

    New Microlearning Video Program! Being civil means interacting and responding courteously and respectfully. This short program helps employees recognize the importance of maintaining a civil, respectful and inclusive workplace. This thought-provoking, powerful short video uses impactful imagery, video and music to encourage discussion on the importance of a civil and respectful workplace. Definitely a good meeting opener or content refresher. Training Materials Included: Discussion Guide
  • 91 Request Info

    PREVAIL!™ - Active Shooter Training

    Ease the fear and build confidence - through powerful training and reinforcement! An active shooter situation is something few of us have prepared for. And it’s that lack of preparation that raises anxiety…and fear. Training increases our ability to take appropriate action. It gives us a greater sense of preparedness, which will help with anxiety and stress levels - especially during a shooter situation. PREVAIL! can be used in any organization. That includes workplaces/businesses, factories, hospitals, schools, government buildings, places of worship, universities/colleges and by first responders. The easy-to-understand 3-OUT Approach (Get out, Lock out, Take out) is intended to create a quick, trained response to an intruder. PREVAIL! can help your organization comply with OSHA's General Duty Clause, Section 5(a)(1).
  • 92 Request Info

    Understanding the HIPAA/HITECH Requirements

    This one-day seminar will get into the fine details of what we need to do and how to do it. We will go point by point through the entire HIPAA Security Rule and uncover simple methods to comply and create policy. The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, as there is so much misleading information regarding the do's and don'ts with HIPAA. I want to add clarity for compliance officers. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018.
  • 93 Request Info

    Statistics for Process and Quality Control

    The objective of the seminar is to provide information that can be used immediately by personnel involved in production operations, and by supervisors and management in decision making. Although the presentation involves use of statistical techniques, presentation of statistical theory will be limited to only what is needed by the attendees to understand and implement processes and testing within the statistical framework.
  • 94 Request Info

    Software Risk Management 2018

    Risk Management is a regulatory and statutory requirement for medical devices. The generic procedure to perform risk management is outlined in ISO14791, however, as soon as software is used challenges arise. How to address these specific software issues and the application of FDA and IEC requirements for development of safety-critical software used in medical devices is the content of this seminar.
  • 95 Request Info

    OSHA 10 Hour General Industry Course

    Outreach training content includes hazard recognition and avoidance, workers' rights, employer responsibilities, and how to file a complaint; it emphasizes the value of safety and health to workers, including young workers. Participants receive a participation card from the US Department of Labor.
  • 96 Request Info

    An Operational Manager to A Strategic Leader

    Managers who want to increase their competitive advantage by anticipating their customers' priorities, needs and expectations Managers who want to distinguish operational data from strategic data, creatively develop sources of information and increase their staffs' flexibility and responsiveness Managers who want to broaden their perspective, improve flexibility without compromising quality and increase their department's value to the organization Every manager who wants to anticipate, initiate and manage change for maximum competitiveness!
  • 97 Request Info

    Living with Depression - Unveiled 2018

    Major depression is a huge challenge in today's society with approximately more than one in 15 people having suffered from a major depressive episode in the last year. Depression is seen in both sexes and in all ages, including children, although it's more common among females and those age 40-59. But many people suffer with depression needlessly because they don't know what depression really is and don't get appropriate treatment. While anyone can write a list of clinical symptoms, it's how depression manifests in real people that really makes a mark.
  • 98 Request Info

    How to be efficient and compliant with 21 CFR Part 11

    This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers.
  • 99 Request Info

    What You Need to Do to Prepare for a Successful Inspection

    Senior management takes responsibility for Quality and GXP compliance. It is not something delegated to the Quality unit or to the Regulatory Affairs group. Developing and implementing an effective Inspection readiness plan will help ensure better results, as well as a less stressful inspection. Planning strategically ahead will reduce document turn-around time, improve presentation skills from SMEs, and increase inspector confidence in the Quality System. Successfully completing an FDA inspection is critical to cGMP operations and commercial success. Implementing and maintaining robust quality systems is one element to accomplishing this goal.
  • 100 Request Info

    Hosting FDA Regulatory Inspections 2018

    The course will go through what typically goes on during an FDA inspection and will then cover how to prepare for, host and follow up to a regulatory inspection. It will focus the things that you should do or not do during the inspection. Typically FDA inspections can be highly structured and there are usually procedures that are to be followed. It is important for anyone who might be involved in the inspection to be aware of these procedures.