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Courses

  • 1 Request Info

    2-Hour Virtual Seminar on Valid Statistical Rationales for Sample Sizes

    This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size. The statistical methods discussed during the webinar include the following: Confidence intervals Process Control Charts Process Capability Indices Confidence / Reliability Calculations MTBF Studies ("Mean Time Between Failures" of electronic equipment) QC Sampling Plans
  • 2 Request Info

    Root Cause Failure Analysis Closed Loop Corrective Action

    Root Cause Failure Analysis 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.
  • 3 Request Info

    How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare

    Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.
  • 4 Request Info

    Do You Make These [Simple Mistakes] In Water System Mythology?

    It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
  • 5 Request Info

    Tricks To Get The [Most Out] Of Your Device Master Records

    Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical File or Design Dossier Table of Contents; The importance and usefulness of the "Essential Requirements"; Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed; Parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed.
  • 6 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.
  • 7 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.
  • 8 Request Info

    Medical Devices - ISO 13485

    Overview: A detailed look at each section of the standard. Real world examples of what to expect, and what to prepare and repeal within the audit guidelines. What must a documentation system look and feel like to ensure compliance? These and many other key details to ensure that your organization has the ability and knowledge to ensure that ISO 13485 is within your grasp.
  • 9 Request Info

    Regulatory Requirements for Biomedical Products

    Overview: Essential documentation serves to demonstrate the compliance of the investigators, Sponsors, monitors/CROs, and IRBs with the current regulatory requirements and ICH GCP standards. Techniques on how to develop best practices and meet all applicable regulatory requirements will be discussed. This session will cover various types of essential documentation, subject specific and non-subject specific, for clinical trials involving drugs, biologics and medical devices trials.
  • 10 Request Info

    Handling Situations Where Regulation (E and ACH) Don't Align

    Overview: This training program will review intent and focus of Regulation E and the ACH Rules.It will analyze situations where Regulation E and the ACH Rules do not align and help determine appropriate responses and procedures to manage risk and loss.
  • 11 Request Info

    Current Concepts and (Future Trends) for Effective Immunization

    Overview: To provide current concepts in seasonal influenza vaccines for the 2018-2019 season To assess how strain matching and efficacy are linked. What vaccines are available this season in USA and ROW. Non egg adapted vaccines. Trivalent and quadrivalent vaccines. This years vaccine composition and WHO recommended strains. Towards a universal Influenza vaccine.
  • 12 Request Info

    Theory and Practice of Near-Infrared Spectroscopy (NIRS)

    Overview: NIR is more complex than typical spectroscopic methods. This webinar will compare and contrast NIRS with "commonly used" spectrometers, now in use and more familiar to analysts. The logic of how various types of NIR equipment is designed and operated, how it obtains and generates spectra, how the software generates results and can control processes.
  • 13 Request Info

    Vendor-CRO-CMO Oversight in the (Biopharma) and Device Industry

    Overview: This webinar is specifically designed for sponsoring biopharma and device companies who are outsourcing.It will help you get to grips with effective Vendors (including CRO,CMO, and other vendors) management used in the biopharma and device industries and your responsibilities as the sponsor. It will also show you how to clarify roles and responsibilities, focus on oversight preparation and planning including understanding insight vendor performance measurement including metrics and key performance indicators.
  • 14 Request Info

    Webinar on Best Practice Case Management Roles and Functions: How to Optimize RN and Social Worker Skill Sets

    Due to the variety of differences in the definition of case management and roles and functions, there is much confusion in the field as to what case management is and how it is applied. Without a national perspective on this issue, many case management departments are not designed to respond to the challenges of health care reform. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Best-Practice-Case-Management-Roles-and-Functions-How-to-Optimize-RN-and-Social-Worker-Skill-Sets-504932/NOVEMBER-2018-ES-TRAININGREGISTRY
  • 15 Request Info

    Paying Physicians for Quality and Value: A Practical Approach

    In this session Mr. Wolfe will provide a practical advice on physician compensation models and will discuss how health care organizations can develop structures that allow for a gradual incorporation of quality and value based metrics starting now.
  • 16 Request Info

    2-Hour Virtual Seminar on Physician Employment Agreements, Contractor Agreements & Legally Complaint Compensation Models

    This lecture will provide an overview of how to read and interpret a typical physician or health care provider employment or contractor agreement. It is critical that any agreement that an employee or contractor is required to sign be provided to the employee or contractor well in advance of the start date with plenty of time and opportunity to review and revise as needed.
  • 17 Request Info

    Medical Device Single Audit Program (MDSAP) Preparation

    Overview: The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP). The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.
  • 18 Request Info

    Root Cause Analysis for CAPA - Myths, Challenges

    Overview: This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We'll also cover the essentials of doing a failure investigation. Why should you Attend: CAPA is the cornerstone of quality improvement and it depends on an effective root cause analysis. Conducting an effective root cause analysis (RCA) can be a daunting task. And without a good root cause analysis, your CAPA will not result in the desired improvement.
  • 19 Request Info

    Control-Analysis Instrumentation used in PAT Continuous [Manufacturing]

    Overview: We will briefly discuss how to go from minimum sampling, sending them to a lab, and waiting for results, to real-time monitoring, taking huge numbers of readings, and how to understand and apply these data to control and improve new and existing products. Also discuss will be how to build the PAT/CM team and set goals, budgets, and make the change-overs smoothly and efficiently. Requirements for PAT/CM equipment: Speed, Precision, ease of use/installation/calibration/validation Types of Equipment: Near-Infrared, Raman, TeraHertz, (for biopharma) Ultra-fast LC Personnel needed: Engineers, Analytical Chemists, Statisticians, Chemometricians
  • 20 Request Info

    Business Continuity Planning for [Computer Systems] Operations

    Overview: Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device, animal health, tobacco and other regulated industries. Disaster recovery activities often include efforts to deal with both system functionality and data integrity, quality, accessibility and accuracy. Business continuity activities often include efforts to deal with system functionality and data integrity, quality, accessibility and accuracy, but the focus is on getting the business processes running in the absence of a sound system or data.