Tel: +65 64965504 *Use the latest version of Google Chrome when registering. In this all-FDA presenter session, participants will hear a high-level overview about new quality guidance. Human error is the most common reason for manufacturing quality failures, but we often stop at addressing this symptom rather than addressing the actual root causes. Taxi fares from DCA are approximately $25 one way, not including tip, and will take about 15 minutes. Embrace the excitement of one of the world's most remarkable urban hubs at Renaissance Washington, DC Downtown Hotel. CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. Moderator: Sharyl D. Hartsock, Senior Director Quality, Global Quality Systems, Eli Lilly and Company, 14:15 | Contamination Control Strategy: Case Study on Microbiological Application lafollette christine Evolving Use of Real-World Evidence in Therapeutic Development and Regulation. Dive into practical and late-breaking analysis on compliance, regulatory changes, and advocacy with top experts. Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration). One way taxi fares from IAD is approximately $70 and from BWI about $85. Moderator: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc. 08:30 | CBER Updates An experienced quality executive will share their knowledge, experience, and lessons learned in the remediation of several consent decrees and warning letters. Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room! New policy, guidance, procedures, oh my! Jean Chung, Chemist, OPQ, CDER, U.S. FDA Phone: +1 (202) 898-9000. Moderator: Denyse D. Baker, PE RAC, Senior Director of Global Regulatory Policy, AstraZeneca, 07:15 | Advancing Regulatory Oversight: An Overview of Initiatives from the Office of Quality Surveillance [emailprotected], Tel: +1 (301) 656-5900 ext. FERC Staff issues Supplemental Notice & Attendee Registration for the New England Winter Gas-Electric Forum, Sunshine Notice | July Commission Meeting, FERC Chairman Glick Names David Ortiz to Head Office of Electric Reliability, Scoping Meeting Regarding the Wisconsin Reliability Project, Frequently Asked Questions: Spillway Inspections, Prohibition of Energy Market Manipulation, Electronic Privacy Act Request Consent for Disclosure of Records, Electronic Privacy Act Request for Individual Access to Records, Designation of Incoming Dam Safety Documents, Office of Administrative Law Judges (OALJ), Office of Administrative Litigation (OAL), Office of Energy Infrastructure Security (OEIS), Office of Energy Market Regulation (OEMR), Office of Energy Policy and Innovation (OEPI), Internet Protocol Version 6 (IPv6) Policy, Information for Jobseekers with Disabilities, Standards for Descriptions of Documents Submitted to FERC, Frequently Asked Questions (FAQs) eLibrary, Second Meeting of the Joint Federal-State Task Force on Electric Transmission, Technical Conference Review of Cost Submittals by Other Federal Agencies for Administering Part I of the Federal Power Act, Technical Conference on Financial Assurance Measures for Hydroelectric Projects, FERC, NERC and Regional Entities Technical Conference: Improving Winter-readiness of Generating Units, Third Meeting of the Joint Federal-State Task Force on Electric Transmission, Technical Conference Regarding Grand River Dam Authority, Technical Conference on Transmission Planning and Cost Management. PDA will not be responsible for any costs incurred by registrants due to cancellation. Kelvin H. Lee, PhD, Institute Director, National Institute for Innovation in Biopharmaceutical Manufacturing (NIIMBL), C3: Contamination Control Strategy: Its Just Good Business Designed for start-ups, SMEs and Academia, our 2022 regulatory update is a one-day event which will take place on 18 October as part of the 2022 TOPRA Annual Symposium, TOPRA in India welcomes you to our webinar presentation: Biosimilar Regulatory Landscape in Emerging Markets: Current Status, Challenges and Future Prospects, Sponsored: Top Labelling Issues and Opportunities Facing UK, Essentials of European Pharmaceutical Regulatory Affairs. London E14 9GE Connecting People, Science and Regulation, Govern./Health Authority/Academic (Member/Non-Member), Corporate Offices, Research and Development. The speakers will ultimately describe how this systemic approach to compliance creates the lifecycle vigilance and adaptability that provides the foundation for consistent quality and supply. If the emails are not in your inbox, please check your spam or junk. Presentations will also include a case-related dive into the draft Guidance for Industry on Inspection of Injectable Products for Visible Particulates (Dec 2021), to be followed by a multi-center panel Q&A. Michael J. Abernathy, MS, RAC, Executive Director, Regulatory Affairs, Amgen Inc. 12:30 1:30 | Lunch with the Regulators Participants will learn about root cause analyses, deficiencies noted in audits, developing an effective Corrective and Preventive Actions (CAPA) plan, and how to properly evaluate such actions to incorporate adaptations that safeguard future batch production cycles of the product. Oct 6, 2022, This page was last updated on July 21, 2022. Rapid advancements in science and technology, expanding global markets, and the onset of the pandemic underscored the need for convergence working in sync with continuous improvement and innovation, mitigating supply chain vulnerabilities, and enabling patient access to breakthrough therapies. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. International Council for Harmonisation (ICH) has a key role in promoting regulatory convergence of quality standards. We suggest you mark the emails as safe so other emails related to the conference will appear in your inbox. The Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) are once again co-sponsoring the PDA/FDA Joint Regulatory Conference, which is now in its 31st year. Over 50 sessions that can help you benchmark your program against leading industry practices and exam concerns. Thursday, Mar 24, 2022, Technical Conference on Financial Assurance Measures for Hydroelectric Projects We had great conversations in Orlando and now you can register to watch at your own pace on-demand. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate. Milind Ganjawala, MS, MBA,Division Director, CDER, U.S. FDA It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Moderator: Bing Cai, PhD, Division Director, CDER, U.S. FDA. Moderator: Paresma R. Patel, Supervisory Chemist, CDER, U.S. FDA, 16:55 | PAI Case Study TOPRA holds several high-level conferences and events annually, including our Annual Symposium in a different European city each year and our Annual Summit in London, to discuss issues of high importance to regulatory affairs professionals. You must have this confirmation letter to be considered enrolled in a PDA event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). Diverse stakeholders will discuss real-world evidence frameworks and present use cases in the following areas: Drug development and approval in rare conditions, Post-market evidence generation for medical devices, The Center for Cancer Systems Pharmacology, HITS - Harvard Program in Therapeutic Science, Program On Regulation, Therapeutics, And Law (PORTAL), MIT Center for Biomedical Innovation (CBI), Pediatric Therapeutics and Regulatory Science Initiative. Learn how many valuable professional and continuing education credits you can earn by attending this years conference. This thought-provoking closing session will discuss how collaboration, innovation, and applying lessons learned to advance industrial quality management are essential to our future success. to learn how real-world evidence is informing regulatory decision-making and advancing knowledge throughout the product lifecycle. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. FDA has published many new documents over the past year.

Alonza E. Cruse, Director, Office of Pharmaceutical Quality Operations, ORA, U.S. FDA, 13:00 14:00 | Concurrent Interest Group (IG) Sessions, A3: Warning Letters and Consent Decree: How to Avoid Them by Staying in Compliance Check in on August 8-9 will begin at 7 a.m. at registration desk. Tel: +1 (301) 656-5900 07:15 | PDA "Achieving Zero Defects for Visible Particles in Injectables" Working Group Update Quality Evolution/Technology Revolution: Modern Quality Management Solutions, 08:00 10:00 | P1: Looking to the Future Madushini N. Dharmasena, Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA, 17:20 | Q&A with Additional Panelists Toni Manzano, Chief Security Officer, Aizon, 16:25 |Agencys View on Data Criticality and Control Mechanisms to Support Data Integrity Program, Including Recent Data Integrity Observations Moderator: Denyse D. Baker, PE, RAC, Senior Director of Global Regulatory Policy, AstraZeneca, 14:15 | Manuel Osorio, PhD, Senior Scientist for Emerging Technologies and Medical Countermeasures, CBER, U.S. FDA, 14:40 | Accelerating Manufacturing Innovation: Shared Understanding and Going First Together The rate is $322 for single or double occupancy. Moderator: Rebecca E. Dowd, MS, Supervisory Investigator, ORA, U.S. FDA, 10:45 | Leveraging Current Technology and Quality Signals to Unlock Bottlenecks in Production while Enhancing Quality Output Contact, ABA/ABA Financial Crimes Enforcement Conference, ABA/IBA Women and Allies Leadership Symposium, Onboarding and Workplace Essentials Online Training, Marketing & Communications Online Training, Certified Financial Marketing Professional, Structured Scenario Analysis Benchmark Reporting Portal, Environmental Social and Governance Network, Americans with Disabilities Act Peer Group, Community Engagement and Reinvestment Committee, Cyber and Information Security Working Group, Diversity, Equity, and Inclusion Advisory Group, Diversity, Equity, and Inclusion Open Forum, Environmental Social and Governance Working Group, Minority Depository Institution Advisory Council, Moderate or Limited Trading Assets Working Group, Mortgage Markets & Lending Technology Committee, Risk Metrics/Key Risk Indicator Working Group, Telephone Consumer Protection Act Working Group, Ability to Repay and "Qualified Mortgage" Exemption, Affordable Housing and Community Investment, Bank Secrecy Act / Anti-Money Laundering (BSA/AML) Reform, Current Expected Credit Loss Standards (CECL), Fiduciary Regulation by the Department of Labor, Flood Insurance Reauthorization and Reform, Community Development & Affordable Housing. Moderator: Mike G. Labruto, MS, Executive Director, Quality Assurance, Gene Therapy Program, University of Pennsylvania. Moderator: Mary Farbman, PhD, Executive Director, Global Quality Compliance, Merck & Co., Inc. New online training to hone your communication skills, Weekly fintech news straight to your inbox, Protect your older customers from financial exploitation.

To book your reservation call Amtrak at +1 (800) 872-7245 or visit www.amtrak.com. Kenneth A. Whitehead, Vice President - Global Manufacturing Services, Eli Lilly and Company, 16:25 | Kevin J. ODonnell, PhD, Market Compliance Manager, Health Products Regulatory Authority, B2: The Digital Automation Revolution: Implementation and Validation J. Kevin Rice, PhD, Review Chemist, CVM, U.S. FDA (INVITED) This session will discuss insights into preventing the conditions that result in regulatory actions, and why this is far better than reactive and costly remediation. 16:00 | Training Won't Fix This pharmaceutical
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