regulatory cmc conferences 2022

Moderator: Sharyl D. Hartsock, Associate Vice President, Global Quality Systems, Eli Lilly and Company, 14:15 | Contamination Control Strategy: Case Study on Microbiological Application No credits will be given for cancellation requests received less than 30 days before the event. Interested in becoming an exhibitor? The Conference emphasizes the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle by vigilantly managing risks to manufacturing and quality. Bethesda, MD 20814 USA 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. An experienced quality executive will share their knowledge, experience, and lessons learned in the remediation of several consent decrees and warning letters. Looking for a chance for real discussions and genuine networking? Tina Kiang, PhD, Director, Division of Regulation, Guidance, and Standards, OPQ, CDER, U.S. FDA, 14:10 |The Need for the FDA Guidance on Inspection of Injectables for Visible Particulates PDA will not be responsible for any costs incurred by registrants due to cancellation. Learn about opportunities and benefits. Generating and delivering pharmaceutical grade water to our manufacturing processes remains a challenge despite decades of experience with this ubiquitous drug component. 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. You will be better equipped to streamline approval processes and deliver uninterrupted product supply chains. [emailprotected], Tel: +49 (0) 30 43 655 08-10 Jennifer A. Maguire, PhD, Director, Office of Quality Surveillance, OPQ, CDER, U.S. FDA, Breakfast 7: Achieving Zero Defects 07:15 | The Microbiology Lab of the 21st Century: Efficiency and Reliability through Automation and Digitization In this session, practical presentations will detail why training alone is not the answer to human error reduction. Registration will be available soon. Rick L. Friedman, MS, Deputy Director, OMQ, CDER,U.S. Want to revisit a keynote presentation? 16:30 | ICH QDG 2022: Global Harmonization via Improved ICH Implementation This three-day CMC regulatory compliance course is designed for senior management, directors, managers, supervisors, project planners and professional staff seeking to develop or implement a Chemistry, Manufacturing & Controls (CMC) regulatory compliant strategy for Cell & Gene Therapy products. Listen to the Halo Effect Podcast Episode. Amsterdam, The Netherlands, Rate: Single Room 219 per night* Learn about opportunities and benefits. Biopharmaceuticals (recombinant proteins, monoclonal antibodies, fusion proteins, bispecific antibodies, antibody-drug conjugates, and biosimilars) are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the regulatory requirements for these challenging products. 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. Life Sciences Suite is powered by the Compliance Foundation platform, which enables unified management of data, content and processes in a familiar user interface combined with powerful automation engine that drives complex process automations, migrations and integrations suitable for both cloud and on-premises deployment models. Gallery Place Metro Station is 0.5 miles away from the Renaissance Washington, DC Downtown hotel and is approximately $2.50 USD one way to Ronald Reagan Washington National Airport (DCA). Or you can disable cookies, but it will affect your experience. 25 years later, we are proud to have helped hundreds of clients complete their projects and thousands of consultants find great assignments. Training programs in industry vary in their design but all are intended to meet the CGMP requirement to ensure employees are qualified for their job function. 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? 11:10 |Industry Perspective on CMC Data Structuring to Manage Knowledge During Product Lifecycle Genpact(NYSE: G) is a global professional services firm that makes business transformation real. Rebecca E. Dowd, MS, Supervisory Investigator, ORA, U.S. FDA, 08:30 10:00 | P5: Current GMP Compliance Trends and Topics DIA is a global association that mobilizes life science professionals from across all areas of expertise to engage with patients, peers and thought leaders in a neutral environment on the issues of today and the possibilities for tomorrow. The purpose of this course is to provide an advanced understanding of the CMC considerations of biopharmaceuticals from development to commercialization. Brooke K. Higgins, MS, Senior Policy Advisor, OC, CDER, U.S. FDA Learn about opportunities and benefits. 13:45 | Human Error = Equipment Failure Susan J. Schniepp, Chair, PDA Board of Directors and Distinguished Fellow, Regulatory Compliance Associates Inc. Laura S. Huffman, MS, CVM Pre-Approval Facilities Assessment Program, Lead, CVM, U.S. FDA 2022 PDA/FDA Joint Regulatory Conference 12-14 September 2022 Michael J. Abernathy, MS, RAC presenter Amgen, Inc. Michael Abernathy, Executive Director, leads Amgen's Global RA CMC function and is accountable for more than 65 staff globally, and a product portfolio of over 80 programs. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). Both topics will demonstrate how putting quality first helps senior leadership transform the quality culture to establish and sustain quality and CGMP compliance for the long haul. An exclusive experience with professional thought leaders provides you with direct insight into current solutions. Lori F. Hirsch, JD, Vice President, Regulatory Compliance and External Engagement, Bristol Myers Squibb, B5: Understanding the Capability of Your Facility to Improve Quality Output The companys patented software-driven solutions include a suite of billing and reimbursement tools for providers and laboratories, market intelligence tools for payers, and a suite of market access solutions for life science companies. The challenge for new processes exists as there is limited knowledge available. DSI shares upcoming attendance at Events where you can request a meeting, or learn more about Regulatory Compliance and CMC Consulting. The hotel can arrange a private driver to pick you (and fellow travellers) up. David L. Chesney, MSJ,Principal and General Manager,DL Chesney Consulting, LLC Timothy J. Pohlhaus, PhD, Consumer Safety Officer, OC, CDER, U.S. FDA, 15:15 16:00 | Refreshment Break in Exhibit Area, 15:25 15:55 | Press Conference (Invite Only), A2: Human Error: Effectively Resolving the Most Common Cause of Quality Failures Tel: +65 64965504 roundtable notes. This exciting co-location means that you'll still have a dedicated conference for WCB focused on FDA and regulatory guidance to ensure CMC success, while also having access to 2700+ bioprocessing professionals, 200+ exhibitors and 200+ scientific presentations across 7 additional tracks in the BioProcess International agenda. After the cut-off date, rooms will be available at the prevailing rate based on availability. BIO Europe. Yet truly effective CAPA should normally include mistake-proofing and not solely stop with retraining an operator. 2023 PDA Pharmaceutical Manufacturing & Quality Conference. Visit Papers and Presentations to access relevant presentations, summary papers, and and transparent workshop format. Other discounts cannot be applied. Overview of chemistry, manufacturing and control (CMC) regulatory requirements and best practices associated with biologic and biosimilar products. 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. 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. CMC Strategy Forum North America 08:00 10:00 | P1: Looking to the Future We appreciate your participation in WCBP 2023 and hope you consider joining us at WCBP 2024 on January 23-25, 2024. We dont believe that one approach, one system, or one methodology is absolutely superior. On 31 October 2022, the FDA announced a limited CMC development and readiness pilot (CDRP) programme to expedite the development of breakthrough products that address an unmet medical need. We're pleased to announce that Shankar Vedantam, host of The Hidden Brain podcast, will be presenting "The Halo Effect: A Discussion" during the closing plenary! She will verify your status and register you. Zhao, until recently a regular on the crypto-conference tour who's said he spent 580 hours in the air in 2022, often takes to Twitter to disparage news reports he dislikes (he has 8.4 million Twitter followers). If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Regulatory affairs courses, webinars, conferences and meetings We offer a comprehensive programme of training courses, conferences, meetings and webinars on a wide range of regulatory affairs topics. FDA Meetings, Conferences and Workshops | FDA One way taxi fares from IAD is approximately $70 and from BWI about $85. To book your reservation call Amtrak at +1 (800) 872-7245 or visit www.amtrak.com. Mary E. Farbman, PhD, Associate Vice President, Global Auditing and Compliance Support, Merck & Co., Inc. B3: Innovative Manufacturing: Pathways to Implementation for Biologics and Biotech Led by our purpose -- the relentless pursuit of a world that works better for people -- we drive digital-led innovation and digitally enabled intelligent operations for our clients. Novel Developments In Drug Delivery System 2. His tweets regularly include crypto jargon like FUD (Fear . We provide insights from each clients data to help them understand what drives the success of their top-performing Salespeople and Sales Managers. Global Pharmaceutical Regulatory Affairs Summit Virtual Pass Booking Form (Checkout Only) Delivered as a Hybrid Event 23rd - 25th October 2023. , Presented in Central European Time (CET) Straight from regulatory authorities and industry leaders, providing insights into policy and real-world case studies. 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. 5 (direction Amsterdam Central Station) and exit at stop Gerrit van der Veenstraat. Tel: +65 64965504 Pharmaceutical Product Development and Manufacturing 8. Moderator: Mary E. Farbman, PhD, Associate Vice President, Global Auditing and Compliance Support, Merck & Co., Inc. 11:00 | CBER Compliance Updates Regulatory Education for Industry (REdI) Annual Conference 2022 June 6 - 10, 2022; Annual Patient Engagement & Regenerative Medicine Meeting 2022: An FDA CBER Workshop for Patient Advocates May 24 . Each person registered as an exhibitor must be employed by the exhibiting company or have a direct business affiliation. Global Regulatory Affairs CMC Conference September 12-13, 2023 | Philadelphia, PA Ensure compliant pre-market & postmarket operations by employing comprehensive product lifecycle management strategies through to stringent supply chain change control processes Register Today Request Agenda Sponsors Program Overview Union Station is 1 mile away from the hotel. (164519 KB), Host Cell Proteins: Identification and Monitoring (169229 KB), ICH Q12- Regulatory insights, Successful Use of PACMP, Case Studies- What Worked, Didn't (147953 KB), Microbial Challenge In-use Studies and Requirements (170793 KB), Multi-attribute Methods (MAM) Implementation Status in Biotherapeutics (145838 KB), Potency Assays and Use of Structure Function Models: Replacing in-vivo with in-vitro Potency Assays at Warp Speed (135893 KB), Process Technology Transfer: Opportunities and Challenges (153243 KB), Quality Risk Management for Cross-Contamination in Multi-Product Facilities (148535 KB), Reference Standards for Cell & Gene Therapy Products - Best Practices for Autologous Therapies (109397 KB), Reference Standards: Common Practices and Challenges (132739 KB), Regulator Review Preferences and Recent Review Trends: Questions and Key Issues (121806 KB), RNA- Vaccines and Therapeutics (155120 KB), Setting Commercial Specifications Beyond Clinical Experience (160006 KB), Successful CMC Approaches to Enable Acceleration (144625 KB), Technical Transfer of Analytical Methods (particularly within sites and buildings) (131801 KB), Use of NMR Fingerprinting in Late-Stage Biologics Development (164935 KB), WCBP 2022 Infographic 800X2000 (260136 KB), WCBP 2023 Infographic 800X2000 (212822 KB), WCBP 2023 Scientific Program (161144 KB). Marea K. Harmon, Consumer Safety Officer, CVM, U.S. FDA, A5: Strong Investigations and CAPA The purpose of the CMC Strategy Forum is to provide a venue for biotechnology/biological product discussion Quality Evolution/Technology Revolution: Modern Quality Management Solutions. 13:45 | What's New in Pharmaceutical Quality (v.2022) 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. Steven M. Solomon, DVM, MPH, Director, CVM, U.S. FDA, 09:15 | ORA Updates Friday, 23 September 2022 Applied Risk-Managed Biopharmaceutical CMC Regulatory Compliance Strategy - Cell Bank through Drug Substance 9:00 CMC strategy applied across the manufacturing process from cell banks to protein production to purification to drug substance Necessity of confirming cell bank clonality and genetic stability 10:30 Coffee Break Moderator: Denise M. DiGiulio, Senior Director, Johnson & Johnson. 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. Biologics CMC: Regulatory Challenges and Trends FDA has published many new documents over the past year. The safety and wellbeing of our attendees is a top priority for PDA; therefore, we will be implementing the following guidelines for training courses: If mandated by national, state, or local guidelines in effect during the dates of any training course, PDA will require masks to be worn indoors regardless of vaccination status. FromNew YorktoNew Delhi, and more than 30 countries in between, we connect every dot,reimagineevery process, and reinvent the ways companies work. Presentations will provide insights into key attributes in organizations that maintain sustainable compliance, including how knowledge-driven systems and a quality assurance foundation lead to durable solutions to complex problems. All have something to offer, and the best approach or best system depends on the sales situation. PDA will not be responsible for any costs incurred by registrants due to cancellation. Schiphol is 15KM away from the hotel, and Rotterdam 65KM. Moderator: Rosemary Orciari, Director Quality, Pfizer. Registration will close July 5, 2023. 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 08:30 10:15 | Plenary 3: Center Office Updates Guided by our experience reinventing and running thousands of processes for hundreds of clients, many of them Global Fortune 500 companies, we drive real-world transformation at scale. 02 Jun, 2020 Overview Speakers Agenda Resources Location CMC and Regulatory Affairs insight without ever leaving your home Need a unique online conference experience? 9th Annual Global Regulatory Affairs CMC Conference Target Audience: Regulatory CMC, Regulatory Affairs September 12-13, 2023 | Philadelphia, PA 10th Annual Food Labeling: Evolving Regulatory Compliance Conference Target Audience: Regulatory Affairs, Regulatory Compliance, Labeling, Nutrition Labeling Learn more. Moderator: Paul Z. Balcer, Program Manager, OC, CDER, U.S. FDA. Upon completion of this course, attendees will be able to: This CMC regulatory compliance course is designed for senior management, directors, managers, supervisors, project planners and professional staff seeking to develop or implement a Chemistry, Manufacturing & Controls (CMC) regulatory compliant strategy for biopharmaceuticals. ISPE. Fax: +65 6496 5599, Manager Registration, Chapters & Membership. It was a great arena to share best practices. While there are no other Conference room blocks, we recommend checking the following hotels for rooms as they are the closest walkable hotels with availability. Our use of data science, specifically Machine Learning, helps us learn about our clients more meaningfully. No valid parking. Regulatory Education for Industry (REdI) Annual Conference 2022 Moderator: CAPT Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER, U.S. FDA. Moderator: Ingrid Markovic, PhD, Senior Science Advisor, Office of the Center Director, CBER, U.S. FDA. This session will also discuss What, Why, and How, in order to scope out and close an investigation. CMC Strategy Forum Europe October 16 to 18, 2023 Derek S. Smith, PhD, Deputy Director, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER, U.S. FDA, B4: How ICH Enables Modernization and Innovation 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: Valerie Whelan, Vice President Quality, Drug Substance Division, Thermo Fisher Scientific. Bethesda, MD 20814 USA He has served on the PDA Board of Directors and chaired the PDA Biopharmaceutical Advisory Board. IGs are your opportunity to make your voice heard! All courses - TOPRA 10:45 | Investigations Related to Media Fills and Sterility Testing First time here? Our courses and webinars are delivered by highly regarded experts from industry and government agencies and are suitable for professionals at all stages of their regulatory career. Pharmaceutical Research & Development 5. International Council for Harmonisation (ICH) has a key role in promoting regulatory convergence of quality standards. It will also provide recent data from observations related to data integrity/management from recent inspections. The case study will also include examples and considerations for managing AI using quality systems to ensure the integrity of the data is properly controlled. Washington, DC CMC Regulatory Compliance is Challenging for Biopharmaceuticals, 9:10 At every stage, we navigate our clients to realize efficiencies in cost and time with our integrated and comprehensive solutions. Susan Laska, MS, 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 Click on the tab below to view Speaker Presentations from the most recent meeting, as well as all Summary Papers.
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