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Best Practices in Preparation for an FDA Computer System Audit _ eMedEvents

Best Practices in Preparation for an FDA Computer System Audit is organized by ComplianceOnline and will be held on Oct 20, 2021.

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Best Practices in Preparation for an FDA Computer System Audit _ eMedEvents

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  1. 13/10/2021, 12:27 Best Practices in Preparation for an FDA Computer System Audit | eMedEvents  Introductory Offer Sign In Assistant Are you an Organizer?   Maximize CME/CE Allowance SEARCH  Advance Search ‹ › Internal Medicine/Family MedicineOncologyRadiologyPsychiatryPediatricsEmergency MedicineNeurologyCardiologyDermatologyDentists Obstetrics and Gynecology Home / Conferences / Best Practices in Preparation for an FDA Computer System Audit  Best Practices in Preparation for an FDA Computer System Audit  By ComplianceOnline   Live Webinar Oct 20, 2021 90 Minutes USD 249.00 REGISTER  Overview Conference Summary Topic Best Practices in Preparation for an FDA Computer System Audit is organized by ComplianceOnline and will be held on Oct 20, 2021. Who Will Bene?t:: This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.). Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management and post-marketing surveillance. Examples of who will bene?t from this webinar include: • Information Technology Analysts • Information Technology Developers and Testers • QC/QA Managers and Analysts • Analytical Chemists • Compliance and Audit Managers • Laboratory Managers • Automation Analysts • Manufacturing Specialists and Managers • Supply Chain Specialists and Managers • Regulatory Affairs Specialists • Regulatory Submissions Specialists • Risk Management Professionals • Clinical Data Analysts • Clinical Data Managers • Clinical Trial Sponsors • Computer System Validation Specialists • GMP Training Specialists • Business Stakeholders/Subject Matter Experts • Business System/Application Testers This webinar will also bene?t any vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance. Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs: • Pharmaceutical • Medical Device • Biologicals • Tobacco (based on the Tobacco Control Act of 2009) Specialties Target Audience Contact Us https://www.emedevents.com/online-cme-courses/live-webinar/annual-current-good-manufacturing-practices-cgmp-training 1/4

  2. ( ) 13/10/2021, 12:27 Best Practices in Preparation for an FDA Computer System Audit | eMedEvents • E-Liquid/Vapor (based on the “Deeming” Act of 2016) • E-Cigarette (based on the “Deeming” Act of 2016) • Cigar (based on the “Deeming” Act of 2016) • Third-Party companies that support those in the above industries • Medical Device software developers • Software as a Medical Device (SaaMD) software developers Why Should You Attend: FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. This guidance was ?rst issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technology changes that have taken place. The FDA computer system guidance was revisited for its application to the medical device industry, as the ?rst issuance addressed pharmaceuticals. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment. This guidance has been modi?ed over the years to make it more palatable to industry, and this includes discretionary enforcement measures. The intent was to avoid creating a huge regulatory compliance cost to industry that was initially preventing companies from embracing the technology. Additional guidance was provided in late 2018 on Data Integrity to address an increasing trend in industry ?ndings. We will cover best practices in industry to address these issues and ensure inspection readiness. This session will provide some insight into current trends in compliance and enforcement. Some are based on technology changes, and these will continue to have an impact as new innovations and technology come into use in the industry. Again, we will help you position your company in a state of inspection readiness. FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with speci?c rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit. It will also take into account areas where FDA will likely focus their effort, including on the higher-risk systems. As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed. This webinar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for computer system validation and maintaining data integrity. The life cycle approach takes all aspects of validation into account throughout the life of the system and the data that it houses. The data is a key asset for any FDA-regulated company and must be protected through its entire retention period. In preparation for an audit, it is important to assess the documentation that was prepared when each GxP system was validated to identify and remediate any gaps or issues. The FDA contact person(s) should be able to tell the story of how each system came into Production in a validated state and how each system is maintained in that validated state with the data integrity assured. It’s important to have the right resources and understanding of the process prior to any inspection. Having the validation information available and key resources who can speak to various components of it is critical and should be arranged in advance. Description: FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with speci?c rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit. It will also consider areas where FDA will likely focus their effort, including on the higher-risk systems. It will cover areas that will help you to plan for an on-site inspection. Areas Covered in the Webinar: • Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology • “GxP” – Good Manufacturing, Laboratory and Clinical Practices • 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES) • Data Archival to ensure security, integrity and compliance • Validation Strategy that will take into account the system risk assessment and system categorization (GAMP V) https://www.emedevents.com/online-cme-courses/live-webinar/annual-current-good-manufacturing-practices-cgmp-training 2/4

  3. 13/10/2021, 12:27 Best Practices in Preparation for an FDA Computer System Audit | eMedEvents processes • Recent FDA ?ndings for companies in regulated industries • The resources, documentation and room preparation necessary to adequately prepare for inspection • Q&A Topic ✔Risk Assessment Risk Assessment ✔Risk Management Risk management in healthcare comprises the clinical and administrative systems, processes, and reports employed to detect, monitor, assess, mitigate, and prevent risks. By employing risk management, healthcare organizations proactively and systematically safeguard patient safety as well as the organization’s assets, market share, accreditation, reimbursement levels, brand value, and community standing. Specialties Risk Management and Medical Negligence Target Audience Pharmaceutical Companies Contact Us Toll free Number 1(800) 828-2059 Email support@eMedEvents.com Chat Assistant Live Chat Reviews Given by People No Reviews available. Be the ?rst to write a review. Add Review Recommended Conferences Hospice and Palliative Medicine Hospice and Palliative Medicine Webcasts Webcasts     RN Learning: Symptom Management: Effective Patient Education Supporting Caregivers in Times of Crisis Hospice and Palliative Medicine Hospice and Palliative Medicine CE 1 CPD 0.75 Hospice and Palliative Medicine Webcasts   The Future of Hospice and Palliative Care: Expert Panel Hospice and Palliative Medicine CPD 1 https://www.emedevents.com/online-cme-courses/live-webinar/annual-current-good-manufacturing-practices-cgmp-training 3/4

  4. 13/10/2021, 12:27 Best Practices in Preparation for an FDA Computer System Audit | eMedEvents Subscribe for Newsletter, Medical News & Blog Updates Subscribe Your Email Address No spam, ever. Your email address will only ever be used for newsletter, medical news & blog updates Conference Organizer Services Marketing & Advertising Speakers Pharma Companies & Medical Device Manufacturers List your Event for Free Marketplace Custom Pro?le Event Marketing & Advertisement Promote your Event Event Listing Promote your Pro?le Advertisement Talk to our Marketing Expert Virtual Event Creation Publish your Work Email Campaign Targeted Marketing Online Event Hosting Network with Peers & Organizers Banner Advertising Data Mining Registration Widget Push Noti?cations Learning Management System (LMS) Search Engine Optimization (SEO) Payment Gateway Social Media Marketing (SMM) Accreditation Web Development Healthcare Professionals (Physicians, Nurses, Dentists..) Medical Resources Travel Deals Find CME/CE Events Online Courses CME Conferences 2021 CME Requirements by Country/ State Stays Free CME/CE Events Webinars CME Conferences 2022 Flights Initial Licensure Requirements Featured Events Webcasts CME Conferences 2023 Cars Medical Assessment Boards Popular Events Journal Based CME CME Conferences 2024 Specialty Certi?cation Boards In-Person Events Podcasts Events by Specialty - Online, In-Person, Hybrid Medical Societies by State Hybrid Events   Events by Location - City, State, Venue Medical Societies by Specialty Cruise Events Non CME Events Medical News Board Review Courses Company         Follow Us Download Our App About Us Blogs Privacy Policy Success Stories Pressroom Cookies Policy       Contact Us Terms & Conditions Copyrights © 2021 eMedEvents Corporation, All Rights Reserved. https://www.emedevents.com/online-cme-courses/live-webinar/annual-current-good-manufacturing-practices-cgmp-training 4/4

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