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 Maik W. Jornitz, MSEng,President and CEO, G-CON Manufacturing, 15:05 | Q&A with Additional Panelists Any individual with a disability who plans to attend this event and requires auxiliary aids or services should notify the Railroad Commission of Texas as far in advance as possible so that appropriate arrangements can be made. Steven Solomon, DVM, MPH, Director, CVM, U.S. FDA, 09:15 | ORA Updates In this session, participants will hear how the use of artificial intelligence (AI) has been applied within the biopharm process validation stages. 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.

Roger Nosal, MA, Vice President, GCMC, Pfizer, 16:55 | FDA Perspective on ICHQ12 Implementation Wei Wang, PhD, Microbiologist, CBER, U.S. FDA, 13:45 14:45 | P6: Moving Forward Valerie Whelan, Vice President Quality, Drug Substance Division, Thermo Fisher Scientific, Breakfast 4: Got 483? Thomas J. Arista, Consumer Safety Officer, ORA, U.S. FDA (INVITED) Guestroom rates are subject to State and Local taxes. Learn how many valuable professional and continuing education credits you can earn by attending this years conference. All costs incurring in connection with visa affairs shall be borne by registrants. Tony Costa, PhD, Chief Executive Officer, DIANT Pharma Inc. 16:25 |Drug Product Development Technical Review and Stage Processes and the PAI Connection Derek S. Smith, PhD, Deputy Director, Office of Pharmaceutical Manufacturing Assessment, CDER, U.S. FDA, B4: How ICH Enables Modernization and Innovation Jeffrey D. Meng, MSE,Program Division Director, OPQO, ORA, U.S. FDA (INVITED) Moderator: Jay Jariwala, Lead Consumer Safety Officer, CDER, U.S. FDA, 07:15 | The FDA-483: History, Law, and Policy Perspectives The regulation of medical devices is continually changing as more innovative technologies and drug-device combinations are being developed. Other discounts cannot be applied. The presenters will emphasize the bright future ahead of us afforded by adopting and committing to good practices in product development, quality systems, and manufacturing performance throughout the lifecycle. We suggest you mark the emails as safe so other emails related to the conference will appear in your inbox. PLEASE READPDA is not affiliated or contracted with any outside hotel contracting company. Washington, DC **After you register, you will receive two confirmation emails: one confirming registration completion and one confirming payment receipt. GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. Case studies are presented throughout the conference to provide practical insights into these concepts and illustrate how sustainable compliance establishes the foundation for quality and supply consistency. John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC. Derek S. Smith, PhD, Deputy Director, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER, U.S. FDA Check-in time is 3:00 p.m.; check-out time is 12:00 p.m. To make reservations, individuals may click on the reservation link above or call the Renaissance at +1 (202) 898-9000. Nicholas A. Violand, Investigator/Drug National Expert, ORA, U.S. FDA (INVITED), 11:10 | A Case Study: Closed Loop Investigation System Ensures Identification and Remediation of True Root Cause 11:00 12:45 | Plenary 4: Compliance Office Updates

Connecting People, Science and Regulation, Govern./Health Authority/Academic (Member/Non-Member), Corporate Offices, Research and Development. 07:15 | Cynthia Lake, Executive Director, Sterile and Microbiology QA, Merck & Co., Inc. (INVITED), 07:40 | Q&A with Additional Panelist Copyright 2022 | Railroad Commission of Texas. Attendees are welcome to attend sessions in other tracks. Tel: +49 30 436 55 08-0 or -10 Mark Wittrig, Director of Quality Operations, Pfizer (INVITED), C5: Lifecycle Management of Risks: From Original Application Approval to Post-Approval 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. Ravi Patel, Director, Quality Engineering & Metrology, West Pharmaceutical Services, Inc. Breakfast 8: Water Systems 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.

J. Kevin Rice, PhD, Review Chemist, CVM, U.S. FDA (INVITED) Moderator: Valerie Whelan, Vice President Quality, Drug Substance Division, Thermo Fisher Scientific. Jim Vesper,Director, Learning Solutions,Valsource, LLC, 14:10 | Tracie H. Sharp, MHA,Branch Chief, OC, CDER,U.S. FDA, B1: Speed vs. Quality: Advantages and Pitfalls of Just-In-Time Manufacturing Breakfast 3: Using Audit Observations to Predict Problems Jean Chung, Chemist, OPQ, CDER, U.S. FDA In this all-FDA presenter session, participants will hear a high-level overview about new quality guidance. 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 someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. Taxi fares from DCA are approximately $25 one way, not including tip, and will take about 15 minutes. The reduction of visible particles in injectable products is an important element in the consistent delivery of high-quality parenteral products. Moderator: Patricia F. Hughes, PhD, Senior Scientific Advisor, CDER, U.S. FDA, 10:45 |Role of KASA and Other Related Initiatives (PQ/CMC) to Manage Application Assessments and Post-Approval Lifecycle Management Moderator: Mai X. Huynh, MS, Supervisory Chemist, CVM, U.S. FDA. Gallery Place Metro Station is 0.5 miles away from the hotel and is approximately $2.50 USD one way to Ronald Reagan Washington National Airport (DCA). Please register for one of the three conference tracks. How often have you found yourself in a fire fighting situation with a project, a lot/batch, a customer audit or inspection where you are doing a significant clean up after the fact with a situation that could have been avoided if there had been a greater willingness to slow down, design, and plan properly before you started? New policy, guidance, procedures, oh my! Bethesda, MD 20814 USA Moderator: Nicole Deschamps, PhD, Product Quality Director, GSK, 07:15 | Matt Harrison, Vice President, Projects & Digital Sciences, GSK, Breakfast 2: GMP at a Distance: The Present and The Future of Remote Regulatory Assessments 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 Manager Registration, Chapters & Membership. The On Demand content will be available starting June 29 until August 31, 2022.

Please bring your registration confirmation emails to check in. 3 Harbour Exchange Embrace the excitement of one of the world's most remarkable urban hubs at Renaissance Washington, DC Downtown Hotel. Ernest F. Bizjak,Compliance Officer/Acting Team Leader, OMQ, CDER, U.S. FDA, 16:55 | Data Driven Supplier Knowledge: Management and Governance Two other airports in the vicinity are both serviced by all major carriers: Dulles International Airport (IAD), 27.8 miles away, and Baltimore-Washington International Airport (BWI), 34 miles away. Learn about opportunities and benefits. After this date, reservations can be made on a space-and-rate available basis only. Laura S. Huffman, MS, Senior Policy Advisor, CVM, U.S. FDA (INVITED) 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 May 6, 2021, Technical Conference Regarding Grand River Dam Authority Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate. Evolving Use of Real-World Evidence in Therapeutic Development and Regulation.

Moderators: Ingrid Markovic, PhD, Senior Science Advisor, Office of the Center Director, CBER, U.S. FDAand Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc. Download TOPRA's Courses & Conferences calendar for 2022 (PDF), TOPRA

10:45 | Donald D. Ashley, JD, Director, Office of Compliance, CDER, U.S. FDA. 13:45 | Tina Kiang, PhD, Director, Division of Regulation, Guidance, and Standards,CDER, U.S. FDA (INVITED), 14:10 |Timothy Pohlhaus, Consumer Safety Officer, OC, CDER, U.S. FDA Cindy L. Burnsteel, DVM, Deputy Director for Drugs and Devices, Office of Surveillance and Compliance, CVM, U.S. FDA, 11:45 | ORA Compliance and Inspectional Activity Updates To book your reservation call Amtrak at +1 (800) 872-7245 or visit David L. Chesney, MSJ,Principal and General Manager,DL Chesney Consulting, LLC Bethesda, MD 20814 USA

Thursday, Mar 24, 2022, Technical Conference on Financial Assurance Measures for Hydroelectric Projects A block of rooms have been reserved for meeting participants at the Renaissance Washington, DC Downtown Hotel. 13:45 | Human Error = Equipment Failure Jennifer A. Maguire, PhD, Director, Office of Quality Surveillance, OPQ, CDER, U.S. FDA, Breakfast 7: Achieving Zero Defects Michele L. Obert, Pre-Approval Manager, ORA, U.S. FDA Priscilla Mara Pastrana Lpez, Consumer Safety Officer, ORA, U.S. FDA (INVITED). * For this member type or discount, online registration is not available, please contact [emailprotected]. Grab your boxed lunch and bring questions for U.S. FDA investigators, reviewers, and compliance officers to this Q&A session that will allow for direct input and will provide you with insights regarding inspection trends and center initiatives. Quality Evolution/Technology Revolution: Modern Quality Management Solutions, 08:00 10:00 | P1: Looking to the Future Tel: +1 (301) 656-5900 The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information. Brooke K. Higgins, MS, Senior Policy Advisor, CDER, U.S. FDA CAPT Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, CDER, U.S. FDA. International Council for Harmonisation (ICH) has a key role in promoting regulatory convergence of quality standards. 14:15 | Consent Decree Remediation Success, A Sustainable Quality System Martin G. VanTrieste, President Emeritus & Board Member, Civica Rx. Rebecca Parrilla, Consumer Safety Officer, OC, CDER, U.S. FDA, C2: Building Quality into Complex Drug Products Moderator: Paresma R. Patel, Supervisory Chemist, CDER, U.S. FDA, 16:55 | PAI Case Study Tel: +1 (301) 656-5900 Second Meeting of the Joint Federal-State Task Force on Electric Transmission Anyone involved in medical devices and in vitro diagnostics needs to keep up to date with both the new EU regulations and the clinical requirements. Moderator: Rick L. Friedman, MS, Deputy Director, OMQ, CDER, U.S. FDA. Moderator: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc. 08:30 | CBER Updates

The challenge for new processes exists as there is limited knowledge available. Richard M. Johnson, MSc, President and CEO, PDA Valerie Whelan, Co-Chair, PDA/FDA Joint Regulatory Conference and Vice President Quality, Drug Substance Division, Thermo Fisher Scientific, 08:30 | Peter W. Marks, MD, PhD, Director, CBER, U.S. FDA, 08:55 | Susan Hynes, MA, Senior Vice President, GSC Quality, GSK, 10:00 10:45 | Refreshment Break in Exhibit Area, 10:45 12:15 | P2: What Does Sustainable Compliance Look Like? If the emails are not in your inbox, please check your spam or junk. If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. are payable online using credit card or electronic check; include breakfast, lunch, and snacks on both days of conference. Oct 6, 2022, This page was last updated on July 21, 2022. QDG reinforced holistic views of quality risk management and science accommodating advanced technologies and approaches such as automation, isolation, digital technology, AI, modeling, knowledge management through data clouds and structured data formats, portable manufacturing, etc., across ICH quality guidelines and therapeutic modalities. 16:00 | Training Won't Fix This An important part of this effort is the control of particles that may emanate from the primary packaging materials. Douglas A. Campbell, Senior Consultant, InterPro QRA, 14:10 |Sandra A. Boyd, Drug National Expert, ORA, U.S. FDA (INVITED), C1: Recently Published Guidances on CGMP and Quality Contact[emailprotected] if you have any questions. Over 50 sessions that can help you benchmark your program against leading industry practices and exam concerns. Rebecca E. Dowd, MS, Supervisory Investigator, ORA, U.S. FDA, 08:30 10:00 | P5: Current GMP Compliance Trends and Topics Jul 20, 2022, WorkshOPP on Filing Comments 07:40 |Q&A with Additional Panelist Are you struggling with an uptick of quality problems and regulatory scrutiny; challenges that can lead to costly regulatory consequences such as a warning letter or worse yet a consent decree? Feb 16, 2022, Technical Conference Review of Cost Submittals by Other Federal Agencies for Administering Part I of the Federal Power Act No walk-up registration is availableRegistration fees: Early check in will be held at the registration desk on the second floor of the AT&T Hotel and Conference Center from 3-6 p.m. on Sunday, August 7. Susan J. Schniepp, Chair, PDA Board of Directors and Distinguished Fellow, Regulatory Compliance Associates Inc. These emails are sent by scammers. The Organisation for Professionals in Regulatory Affairs Limited | Registered in England Company Number 01400379 | VAT number GB 342 7398 40, Copyright 2022 The Organisation for Professionals in Regulatory Affairs, Regulatory Updates for Start-ups, SMEs and Academia 2022, TOPRA in India - Biosimilar Regulatory Landscape. Forgeneral conference inquiries or questions, email the Railroad Commission of Texas 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. Check in on August 8-9 will begin at 7 a.m. at registration desk. Reagan National Airport (DCA) is approximately 5 miles from the hotel and all major carriers service this airport. The roles of robust systems, facilities, processes, raw material quality, supplier relationships, industrial modernization, and quality risk management are emphasized. Moderator: John D. Ayres, MD Risk Assessment Clinician, Pharma Safety Solutions, LLC. Transcripts of Commission Meetings, Scoping Sessions, Conferences and Hearings are available for a fee from Ace-Federal Reporters, Inc. at (202) 347-3700, prior to when they are posted in the respective dockets on Tel: +1 (301) 656-5900 Moderator: Ekaterina Allen, Consumer Safety Officer, CBER, U.S. FDA, 07:15 | Susan Laska, Deputy Chairperson, Pharmaceutical Inspection Co-operation Scheme (PIC/S) and Deputy Assistant Commissioner, OMPTO, ORA, U.S. FDA (INVITED), 07:40 | Q&A with Additional Panelists Rick L. Friedman, MS, Deputy Director, OMQ, CDER, U.S. FDA, 15:45 16:30 | Refreshment Break in Exhibit Area, A4: Pre-Approval Inspections: Facility Deviations, Findings, and FDA 483 Responses If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately. You can still register to get access to these sessions. Lisa Gibson, Director of QA New Site Integration, Thermo Fisher Scientific (INVITED), Breakfast 6: FDAs Next Steps in Advancing Quality Metrics and Maturity Madushini N. Dharmasena, Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA, 17:20 | Q&A with Additional Panelists

She will verify your status and register you. Moderator: CAPT Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, CDER, U.S. FDA.

Dive into practical and late-breaking analysis on compliance, regulatory changes, and advocacy with top experts. 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. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Deviations, defects, complaints, and out of specification results are among the areas that require careful investigation to prevent marketed product recalls and supply shortfalls. One way taxi fares from IAD is approximately $70 and from BWI about $85. International collaboration efforts that improve quality and benefit the consumer are also highlighted. 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. The patient and business benefits of a persistent focus on a preventive (the P in CAPA) mindset throughout operations will be explored. For later registrations, PDA Europe will be unable to assist participants in any visa affairs. Reservations must be secured by Monday, 15 August 2022. Four days of real-time strategies and future-focused solutions to ensure your team is prepared for tomorrow's challenges. Fax: +49 30 436 55 08-66, 4350 East West Highway, Suite 110 An experienced quality executive will share their knowledge, experience, and lessons learned in the remediation of several consent decrees and warning letters. Parking is available onsite at the following rates: Daily Self Parking - $35; Daily Valet Parking - $60.18. 14:35 | Q&A with Additional Panelists The scope of this PDA working group's activities will be discussed, including test and inspection methods, acceptance criterion considerations, and training opportunities. Jacqueline Corrigan-Curay, JD, MD, Principal Deputy Center Director, CDER, U.S. FDA, 09:00 | CVM Updates Real-life examples will address the roles of risk analysis, process performance monitoring, CAPA, digital tools and continual improvement in minimizing human error and its impact. The second speaker is Susan Hynes, the Senior Vice President of Global Supply Chain Quality at GSK. New online training to hone your communication skills, Weekly fintech news straight to your inbox, Protect your older customers from financial exploitation. This session will also discuss What, Why, and How, in order to scope out and close an investigation. Statements claiming to offer our attendee lists are fraudulent. PDA will not be responsible for any costs incurred by registrants due to cancellation. 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 10:45 | Investigations Related to Media Fills and Sterility Testing Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Peter W. Marks, MD, PhD, Director, CBER, U.S. FDA, 08:45 | CDER Updates Union Station is 1 mile away from the hotel.

Moderator: Sharyl D. Hartsock, Senior Director Quality, Global Quality Systems, Eli Lilly and Company, 14:15 | Contamination Control Strategy: Case Study on Microbiological Application [emailprotected], 4350 East West Highway, Suite 600 Rick L. Friedman, MS, Co-Chair, PDA/FDA Joint Regulatory Conference and Deputy Director, OMQ, CDER, U.S. FDA Dr. Peter Marks, FDAs Director of the Center for Biologics Evaluation and Research, will kick-off the 31st PDA/FDA Joint Regulatory Conference with a presentation on the synergies between science, compliance, quality, and facility capabilities. Moderator: Denise M. DiGiulio, Senior Director, Johnson & Johnson. Aug 30, 2022, New England Winter Gas-Electric Forum Michael J. Abernathy, MS, RAC, Executive Director, Regulatory Affairs, Amgen Inc. 12:30 1:30 | Lunch with the Regulators PANELISTS Kelvin H. Lee, PhD, Institute Director, National Institute for Innovation in Biopharmaceutical Manufacturing (NIIMBL), C3: Contamination Control Strategy: Its Just Good Business