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Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This session provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, etc. FDA inspections are completed primarily to identify potential problems that may affect public health and safety. An inspection of manufacturers of regulated products is meant to assess the resources, controls, procedures, and practices that are in place for the development, manufacture, testing, storage, handling, and distribution of a product. Ideally, inspections should be viewed as a learning experience and should be conducted as a cooperative effort between the investigator and the site. Inspections may be conducted for: routine surveillance, to complete benchmarking activities, during pre- and post-approval proceedings, and may be initiated “for cause,” considering some violation of the regulations. Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favorable outcome and ensure “state of readiness.”
• Why inspections are conducted and by what statutory authority?
• The emphasis on systems-based inspections…and the IOM and other crucial FDA reference documents.
• What is subject to FDA purview and what's off-limits?
• Understand and apply the do's and don'ts and comprehend that preparation is the key to success.
• What are the prohibited "Acts" and the enforcement categories that you need to deal with.
• What you need to know and do to prepare for, during and even after the inspection…and why your inspection response team is key?
• The company's Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel.
• How to respond to findings and facilitating the documentation and remediation process…and reaching final closure
• How to respond to inspection and audit results
• Understand the FDA inspection process and approach
• What to do before, during and after the Inspection?
• Responding correctly to the Investigator’s questions
• Tips for Handling a FDA Inspection the right way
• Why the exit interview and close-out is an important part of handling an inspection
• What are the Prohibited Acts?
• FDA Policies Regarding Pre-Announced Inspections
• Develop procedures for managing Inspections
• Establish an Inspection Management Team
• Consider Inspection logistics in advance
• Conduct the exit interview and close-out meeting with FDA very carefully
• Possible Inspection outcomes
Who will benefit:
This webinar will provide valuable assistance and guidance to all regulated companies that are preparing for FDA inspections. The employees who will benefit include
• All levels of Management for all departments
• Regulatory Affairs
• Information Technology
• Marketing & Sales
• Engineering/Technical Services
• Operations and Manufacturing
David R. Dills, Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, cosmetics and bio/pharmaceutical manufacturers on the global landscape, and also has an accomplished record with more than 25 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 has been directly involved with constructing, reviewing, and/ or remediating regulatory submissions, including 510(k), PMA, IDE applications, IND, BLA and NDA submissions, preparing Supplements, Amendments, 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 postmarketing; retained as U.S. Agent for international pharma and device clients; conducting supplier and QS audits/assessments; 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, Postmarketing Surveillance and Vigilance Reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing.
Mr. Dills manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations/commercial opportunities. Develops strategies for governmental approval to introduce new products to market, provides guidance and clarity on regulatory requirements, prepares and/or reviews submissions [e.g., NDA, ANDA, 510(k), PMA, IDE and BLA], including design dossiers and technical files, and other applications for Asia Pacific, The Americas and EU. Directs and leads efforts in establishing and retooling QA systems with emphasis on preventing the design, manufacture, and shipment of defective product; provide compliance engineering support; and lead efforts for GxP Strategic Compliance.
Mr. Dills manages regulatory problems (e.g. AE’s, MDRs, Agency enforcement, and complaints) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems; documentation development and remediation; RA/RC oversight and governance; design controls; CAPA/investigations; GxP training; software and process validation with compliance oversight; supplier management; interfaces with FDA and other Agencies on the regulatory landscape; compliance with MDD/IVDD Directives and Technical File/Design Dossier and CE Mark requirements; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure.
He also develops strategies and adds business value to manufacturers by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones and on minimizing delays due to noncompliance. He conducts Compliance Governance Assessments and Agency Mock Inspections; provides assistance during inspections and with post-inspection correspondence and meetings, involved in the product life cycle and commercialization process and works effectively across all functions for overall corporate compliance to support a company’s goals and strategies.
Mr. Dills analyzes the benefits/risks for informed decision-making; interprets the regulatory precedents and new legislation; understands the competitive landscape; develops the business and regulatory approach; conducts persuasive communication with regulatory authorities; executes an effective path to approval; assists with GxP compliance strategies, effectively coordinates development in multiple markets; selects appropriate testing and manufacturing suppliers; and strives for overall corporate compliance with regulations in The Americas, EU, and Asia Pacific.
He provides direction on understanding the regulatory landscape for the product and provides a fully integrated approach to device development including design controls, and effective communications with Regulatory Authorities related to product development and post-marketing activities.
Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute, Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers’ Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore’s Who’s Who of Professionals.
Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills’ academic degrees include Environmental Science and Biology. He is a former Chair and Co- Chair of ASQ’s Section 1506 and associated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups