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Courses

  • 1 Request Info

    21 CFR Part 11 Compliance Checklist- FDA Software Validation

    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. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901525SEMINAR?trainingregistry-March-2018-SEO
  • 2 Request Info

    21 CFR Part 11 Compliance for Computer Systems Regulated by FDA 2017

    The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901297SEMINAR?trainingregistry-November-2017-SEO
  • 3 Request Info

    21 CFR Part 11 compliance for software validation and SaaS/Cloud 2017

    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. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation. Today the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements
  • 4 Request Info

    Applied Statistics for FDA Process Validation 2017

    In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further delineates the 'process design stage through commercial production' into three distinct stages of the product lifecycle: Stage 1: Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities. Stage 2: Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900806SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 5 Request Info

    Applied Statistics for Scientists and Engineers

    Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting validation criteria and specifications, performing measurement systems analysis (MSA), conducting stability analysis, using design of experiment (DOE) for process development and validation, developing process control charts, and determining process capability indices. Different statistical methods are required for each of these particular applications. Data and tolerance intervals are common tools used for setting acceptance criteria and specifications. Simple linear regression and analysis-of-covariance (ANCOVA) are used for setting expiries and conducting stability analysis studies. Two-sample hypothesis tests, analysis-of-variance (ANOVA), regression, and ANCOVA are methods used for analyzing designed experiment for process development and validation studies. Descriptive statistics (distribution
  • 6 Request Info

    Applied Statistics for Scientists and Engineers 2017

    Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting validation criteria and specifications, performing measurement systems analysis (MSA), conducting stability analysis, using design of experiment (DOE) for process development and validation, developing process control charts, and determining process capability indices. Different statistical methods are required for each of these particular applications. Data and tolerance intervals are common tools used for setting acceptance criteria and specifications. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901138SEMINAR?trainingregistry-December-2017-SEO
  • 7 Request Info

    Applying ISO14971 and IEC62304 | Risk Management Seminar 2018

    Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management.
  • 8 Request Info

    ARC005 - ARC's Fundamentals Finance & Accounting for Non-financial Professionals

    This is for those who are new to management or who need to understand and use financial statements. You will learn how to Talk the Talk and Walk the Walk. From how the statements work, to how to read them, to how to calculate the ratios that provide meaning. for new managers, purchasing and sales professionals and anyone who needs to communicate with those accountants.
  • 9 Request Info

    ARC011 -ARC's Financial Modeling & Forecasting Using Excel Course

    Using Excel®, the Financial Modeling and Forecasting process provides an effective tool with which the you and project the potential outcomes of various strategic and tactical initiatives. The ability to answer the question “What are the potential results?” is key and critical. Forecasting models empower mangers and process owners to “Walk the Walk” prior to any significant investment of corporate resources. Using Excel©, you will learn how to calculate the impact time has on future cash flows, how to project the benefit of capital projects, make lease vs. buy decisions, determine the cost of capital, and project EVA©. Also, using Excel©, you will learn how to evaluate organizations with which you are planning to do business; determine if they are able to provide strategic strength to your company. Participants will be provided Excel© templates for use during this session, and when they return to their organizations.
  • 10 Request Info

    Background Checks, Criminal Records and Safe Hiring 2017 Effective and Compliant Program 2017- Before 30 April 50% Discount for its All Seminars

    Employee problems are caused by problem employees, and this session will help HR professionals legally avoid bad hires in the first place. Just one bad hire can result in a legal and financial nightmare. Without taking appropriate steps, there is a near statistical certainty that an employer will hire someone with an unsuitable criminal record, or a falsified background, that can result in workplace violence, lawsuits for negligent hiring and time wasted recruiting and hiring the wrong person. On the other side of the screening fence, are the rising tides of lawsuits against employers alleging screening methods violate the law or are at odds with changes in civil rights legislation and the new EEOC Guidance on the use of criminal records. The screening landscape is more complex than ever. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900916SEMINAR?trainingregistry_SEO
  • 11 Request Info

    Compliance for Electronic Records and Signatures

    Overview: This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity.
  • 12 Request Info

    Conducting An Effective Recall (Managing Internal and External Customers)

    This webinar will provide you knowledge to establish a plan for conducting recalls, The knowledge you gain will sharpen your recall management decisions and strategy, And You will learn that your approach to recalls plays a major role in mitigating direct and indirect damage to your firm's business.
  • 13 Request Info

    Consultants for Instructional Design, Training & Development, Organizational Development & Human Resources

    KAW Consulting provides Training & Development, Instructional Design, Organizational Development and Human Resource Consulting. KAW also provides Team & Personal productivity tools, such as Meetings That Work that can be purchased directly via our online store.
  • 14 Request Info

    Control Systems Technology - SCADA and PLC Training

    Case studies are used with examples of real world working SCADA and PLC systems in the water, electrical and processing industries.Get the latest developments in SCADA and PLC systems, fundamentals of their design, installation and troubleshooting.
  • 15 Request Info

    Creating a Drama Free Workplace

    Overview Learn to deal with aggression, passive-aggression, gossip, conflict, victims and all forms of drama. Do you feeling Frustrated? Overwhelmed? -with the constant Drama in your workplace. Discouraged that you can't avoid it and don't know how to make it stop? Drama takes many forms: incessant gossip -its divisive and unproductive AND you wonder what they're saying behind your back personality conflicts that create constant tension and bickering
  • 16 Request Info

    Design Controls for Medical Devices - Regulations, Myths, Challenges, and Best Practices 2017

    Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet is still one of the most frequent areas for 483 and Warning Letter observations. This 2 days seminar will help you understand and develop design controls processes and tools that are a competitive strength for your company. Intrinsic quality, safety, and effectiveness of a device are known to be established during the design phase. Yet, statistics show that a significant percentage of all medical device recalls are due to design problems. And design problems can have disastrous results for your customer and for your company.
  • 17 Request Info

    Developing Conflict Competent Leaders

    In this webinar, participants will learn how to harness the power of conflict as leaders in their organizations. Participants will examine their own conflict styles and those they lead. In addition, the various types of conflict that exist will be looked at and strategies leaders can use to deal with conflict that can be disruptive to their organizations. Special attention will be given to conflict on teams, between departments and other outside organizations a leader may have to deal with.
  • 18 Request Info

    Drug dissolution testing and establishing plasma drug levels in humans 2017

    Drug dissolution testing is an essential and critical step for appropriate and efficient product development such as tablet and capsule. A number of approaches are used to conduct dissolution testing using different apparatuses and methods. Making a choice for an appropriate apparatus and method has always been confusing and challenging. This seminar will provide relevant pharmacokinetics and physiological background so that making this choice becomes easier and instinctive. No prior knowledge of pharmacokinetic and/or physiology is required; however, these will be explained in very simple terms to help attendees in selecting or developing a dissolution method. This seminar will describe in detail the theoretical aspect of the drug dissolution testing including method development. Pros and cons of different approaches will be explained in detail.
  • 19 Request Info

    Equipment and Facility Qualification 2017

    Overview: Equipment Qualification, process validation and commissioning have some overlapping areas that have over the years been the source of confusion. This webinar removes that confusion between equipment Qualification, process validation and Facility commissioning.
  • 20 Request Info

    Exceptional Coaching and Team Building Skills

    Dr. Rick Goodman is a professional speaker, motivator, author and training consultant helping organizations Develop Great Leaders - Through Excellence in Communication, Team Building, Change Management, and Customer Excellence. Dr. Rick = RESULTS