FDA and U.S. Customs and Border Protection are using new import requirements.The FDA’s import software screening program (PREDICT) and the U.S. Custom’s ACE software program require more information from the foreign source(s). FDA’s product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. Take away is that the software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry’s commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. All products regulated by the Food and Drug Administration must meet the same requirements, whether imported from abroad or produced domestically. The job of protecting consumers includes an ever-increasing need to oversee imports, which have been increasing by 5-10 percent per year for the last decade, and those percentages expect to keep rising. The FDA continues to change its import program to better manage new problems and to use new procedures to make the whole process easier. The FDA and U.S. Customs and Border Protection (CBP) are relying more and more on computer programs to expedite the import process. The new import entry filing requirements became effective in 2016 and are posing problems for the user. Failure to provide the correct information creates costly delays. In some cases, you will need to contact FDA to resolve the problem.
The FDA continues to change its import program to better manage new problems and to use new procedures to make the whole process easier. The FDA and U.S. Customs and Border Protection (CBP) are relying more and more on computer programs to expedite the import process. The new import entry filing requirements became effective in 2016 and is posing problems for the user. Failure to provide the correct information creates costly delays.
• FDA’s required information for the PREDICT software screening prior to entry
• FDA product codes
• Custom’s required information for the ACE software system prior to entry
• Custom’s Harmonized Tariff Schedule (HTS)
• Affirmation of Compliance (AOC)
• FDA’s new cost-saving import programs
• Understand how U.S. Customs and FDA legal requirements intersect
• Know how to manage foreign suppliers
• Understand FDA’s internal procedures
• Learn how to mitigate and resolve import detentions
• Learn how to avoid common problems
• How do you deal with the FDA and the U.S. Customs and Border Patrol procedures?
• What happens when your product is detained?
• What happens if a foreign manufacturer is in trouble with the FDA?
The webinar focuses on FDA's software screening program, PREDICT, and U.S. Custom's ACE program that require careful attention for being prepared and compliant.
This webinar will provide a valuable and informative overview and guidance to manufacturers, especially medical device companies and biopharmaceutical companies preparing for FDA inspections. The employees who will benefit include:
• All levels of management and departmental representatives and any anyone who desires a better understanding of the new program from end-to-end and the ground rules
• Legal Counsel
• Regulatory Management
• Regulatory SME
• Regulatory Affairs/RA Specialists
• Technical Services/Operations
• Project Managers
• Business Planning Executives
• Regulatory Managers
• In-house Legal Counsel and Contract Specialists
• Venture Capitalists
• Business Acquisition Executives
• Owners of New or Developing Import/Export Firms
• International Trade Managers
• Import Brokers
• Logistics Managers
• Sales Managers
Years of Experience: 26+ years
Areas of Expertise: Regulatory Affairs, Compliance and Quality Systems
David R. Dills, Global Regulatory Affairs & Compliance Consultant, Interim President, currently provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, nutraceuticals/supplements, cosmetics and biopharmaceutical manufacturers in multiple medical specialties and therapeutic areas on the global landscape, and has an accomplished record with more than 26 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA’s, warning letters,483 observations, and customer generated compliance events, and prepares for and conducts QS and regulatory audits. He is currently acting and interim President at NovaQual LLC.
He has been directly involved with constructing, reviewing, and/ or remediating regulatory submissions, including 510(k), PMA, IDE applications, IND, BLA and NDA submissions, preparing responses to AI’s/deficiency letters, Supplements, Amendments, acting U.S. Agent, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and post-market project leadership and guidance covering different therapeutic and medical specialties based on classification.
Mr. Dills has a strong background in the interpretation and applicability of FDA regulations, including 21 CFR 210/211, 820 QSR/cGMP, Quality System implementation and compliance requirements, GxP training, leads and directs activities for the registration and approval process and working with Agencies in Asia Pacific, EU and The Americas, including but not limited to FDA, European Medicines Agency–EMA, MHRH, ANVISA, PMDA, MOH, SFDA, TGA, and Health Canada; and defining and executing regulatory compliance, risk mitigation and remediation strategies in response to inspection findings. Additional activities include Pre-FDA Facility Inspections, Mock Audits/Due diligence and assessing state of readiness for Pre-approval inspection (PAI/PMA), proof of management oversight, facilitate and direct efforts for remediation planning and monitoring, and assessment of the critical sub-systems, records and document controls; and strives for reduction of regulatory compliance risk for companies.
Directs and leads efforts for PM support and consultative services on behalf of manufacturers and subcontracted by third-party consultancies and provides services involving all phases of the product development, submission, and commercialization process from premarketing to post marketing; retained as U.S. Agent for international pharma and device clients; conducting supplier and QS audits/assessments; UDI compliance strategies; establishment registration and listing; Agency inspection readiness preparation and remediation; preparing Agency responses due to enforcement actions; conducting GxP audits and preparing CAP/remediation plans; compliance engineering support; support and/or lead efforts regarding Adverse Event, MDR, Incident Reporting, Post marketing Surveillance and Vigilance Reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO13485 registration and CEMark; and multi-country product registrations and licensing.View all trainings by this speaker