Health and Environment Training Classes

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.

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).

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.

The Occupational Safety and Health Administration (OSHA) has jurisdiction to protect the workers of America and its territories from harmful working conditions. They are a department under the US Department of Labor and was given the legal authority to create standards to regulate most work environments through the Occupational Safety and Health Act of 1970. A key component of the department's measure of how well it is protecting employees is by injury and illness recordkeeping.

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.

This presentation will discuss key compliance issues with respect to medical director contracts. More specifically, it will discuss the regulatory framework governing medical director contracts, key compliance issues, how to audit for medical director contract compliance, and recent government enforcement trends relating to medical director agreements.Price:$160.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Medical-Director-Contracting-Key-Pitfalls-to-Avoid-506752/SEPTEMBER-2018-ES-TRAININGREGISTRY

HIPAA law applies to Business Associates in healthcare - BAs are organizations that create, receive, maintain or transmit Protected Health Information (PHI) - on behalf of a Covered Entity or to provide a service or function involving PHI for a covered Entity - and are directly liable for compliance with HIPAA law protecting the privacy and security of PHI. Price:$160.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Business-Associates-2018-5-Top-HIPAA-Compliance-Priorities-503760/SEPTEMBER-2018-ES-TRAININGREGISTRY

This webinar will provide attendees with the information and tools necessary to develop, implement, and effectively utilize and maintain a program for supplier quality management that will satisfy the FDA's requirements without creating undue burdens for the organization, Also this training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain.

Overview: Use of analytical methods is widespread. However, there are no formally accepted guideline or formats for the overall process of design, development, optimization & validation of analytical methods.Many analytical methods, lacking full and adequate validation have been introduced into the open literature and allowed to assume aura of authenticity but, they may never work or be useful with samples that are typically encountered.

This webinar will explain how the 21st Century Cures Act will impact the current pharmaceutical and medical device industries, particularly their processes for new product and new product indication requests, It also provides new authority to help FDA improve our ability to recruit and retain scientific, technical, and professional experts and it establishes new expedited product development programs.