Health and Environment Training Classes

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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

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.

Overview: This training program will enumerate the IIA Standards and the auditor's responsibility to abide by the standards. The program will also look at management's expectations of internal audit and detail skills required for internal audit management. It will provide real-world examples and challenges facing today's internal audit. "Becoming a Chief Audit Executive -Leading the Internal Audit Function" -This course is approved by NASBA (National Association of State Boards of Accountancy). Attendees of Live Webinar are eligible for 1.8 CPE credit up on full completion of the course.

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.

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.

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.

Why you should attend Introductions and overview of the EU Directives Identify the EU Directives and standards applicable to your product Comply with the implementation details and requirements of the EU MDR & IVDR Design a new product, or evaluate an existing product, for conformity with these Directives and standards

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.