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Courses

  • 81 Request Info

    SQL Server 2017 Reporting Services Training Course

    This course introduces Microsoft's SQL Server Reporting Services 2017 (SSRS) utility. All reports are developed utilizing SQL Server Data Tools (SSDT), however Report Designer is also introduced. Students will complete hands-on exercises creating a number of reports including table-based, cross tabular and forms based designs. Reports utilizing charts, gauges, KPIs, spark lines, data bars and tree maps will be built. Exercises will incorporate the use of report parameters and features such as drill down, interactive sorting, hyperlinks, book marks and report maps. The student will gain experience with the new Report Services Web portal, which enables publishing content other than paginated reports, such as Excel and Power BI. Students will also learn how to include KPIs (Key Performance Indicators) directly from a shared data set.
  • 82 Request Info

    SQL Server 2016 Business Intelligence: Integration Services and Analysis Services Training Course

    The focus of this course is to familiarize developers with the use of SQL Server Engine, SQL Server Integration Services (SSIS) and SQL Server Analysis Services (SSAS) to create and populate data warehouses through ETL processing and build Multidimensional and Tabular models to use and reporting data sources. Students will learn how to design and build data warehouses and marts using SQL Server Management Studio. In a series of exercises, students develop SSIS packages designed to maintain a data warehouse using the Data Flow control flow task. Also demonstrated are other control flow tasks that can interact with an NTFS file system, FTP server, execute Win32 processes, send emails, and run .NET scripts. Based on the populated data warehouse they have created, students will then learn how to develop both Multidimensional and Tabular SSAS models using the languages Multidimensional Expressions (MDX) and Data Analysis Expressions (DAX).
  • 83 Request Info

    How to be Efficient and Compliant with Part 11, 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.
  • 84 Request Info

    HIPAA Privacy, Security, and Breach Notification Rules

    This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associates. The session provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate. Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided.
  • 85 Request Info

    Applied Statistics for FDA Process Validation 2019

    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. Stage 3: Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.
  • 86 Request Info

    How to be efficient and compliant with 21 CFR Part 11, data integrity, SaaS/Cloud, and EU GDPR

    This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments.
  • 87 Request Info

    Tougher Import Rules for FDA Imports in 2018

    FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures.
  • 88 Request Info

    Excel Spreadsheet Validation 2018: Tools and Techniques to Meet FDA Requirements

    Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment.
  • 89 Request Info

    HIPAA Compliance - Clear, Complete, Step-by-Step

    Organizations of all types and sizes continue to struggle needlessly with HIPAA Compliance. For example, HIPAA Risk Analysis – Risk Management is the basis of the HIPAA Compliance Program of every Covered Entity and Business Associate. But mandatory HIPAA Compliance Audits conducted by the Office for Civil Rights (OCR), the HIPAA enforcement arm of the U. S. Department of Health and Human Services (HHS), found 94% of Covered Entities failed the Risk Management Audit and 87% failed the Risk Analysis Audit. And every audited Covered Entity knew well in advance that it was on the short list to be audited, had completed pre-audit questionnaires and knew the exact questions it would be asked and documentation to be provided (audit protocols).
  • 90 Request Info

    Introduction to Adaptive Design for Clinical Trials

    This 2-day seminar includes an overview of Adaptive Design, and an emphasis in group sequential design, sample size re-estimation, and Phase II/III Adaptive Seamless Designs.
  • 91 Request Info

    Quality by Design - Essential Techniques for Medical Devices

    Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet, Design Controls are still one of the most frequent areas for 483 and Warning Letter observations. This two-day seminar will help you understand, develop, and implement Design Controls processes and tools that are a competitive strength for your company. You will learn how to incorporate Design Controls into your product development process to help streamline development and ensure Quality and compliance.
  • 92 Request Info

    US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus

    This ICH GMP 2-Day seminar will provide your company the opportunity for comprehensive understanding of ICH GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan). It will cover the key areas of how ICH 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. The seminar will discuss in detail the: Types of inspections done by US FDA, EMA and PMDA Typical Audit Agenda that can be expected by each Authority Scope of Audits.........how many auditors, how many days When audits will likely occur The expectation differences between inspections of API and Finished Product facilities What areas of GMP become a focus by region
  • 93 Request Info

    Validation and 21 CFR Part 11 Compliance of Computer Systems

    We have all heard of Computer Systems Validation & Data Integrity, but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following: 21 CFR Part 11 and Computer Validation: Why so many citations? Computer Systems Validation (CSV) and 21 CFR 11 vs Annex 11 Data Integrity vs Computer Systems Validation Overview and Key Requirements of Part 11 & CSV How to use a Risk Based Assessment to reduce work while still achieving Compliance? How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity?
  • 94 Request Info

    FDA Scrutiny of Promotion and Advertising Practices

    If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other.
  • 95 Request Info

    Strategies for Improving Effectiveness and Efficiency of your Quality Management System

    This two-day seminar will cover the essentials of an effective yet efficient Quality management system for medical device companies. An efficient and effective Quality System can be a competitive advantage for companies by leading to improved Quality and compliance as well as optimizing the cost of quality. This seminar will get you started in setting up just such a Quality System. We'll discuss the "case for quality" and how you can use compliance, not as an end itself, but as a means to improved quality and reduced cost of non-compliance.
  • 96 Request Info

    2-day In-person Seminar Combination Products

    This seminar provides Professionals working in this area with: A thorough understanding of the complexities involved Covers all the relevant regulations and guidelines Gives real life examples of how to register and maintain various types of combination products Interfaces: Change Management and LCM Compliant safety reporting for combination products Documentation requirements and interfacing
  • 97 Request Info

    Combination Products

    This seminar provides Professionals working in this area with: A thorough understanding of the complexities involved Covers all the relevant regulations and guidelines Gives real life examples of how to register and maintain various types of combination products Interfaces: Change Management and LCM Compliant safety reporting for combination products Documentation requirements and interfacing
  • 98 Request Info

    Complaint and Recall Management: A Compliant, Lean Program

    Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints! This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback.
  • 99 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.
  • 100 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.