2-day In-person Seminar

How FDA Trains Its Investigators and Inspectors to Review Sub-Systems for State of Compliance: What You Need to Do to Prepare for a Successful Inspection


September 26th & 27th, 2018

Time: 9:00 AM to 5:00 PM

Washington, DC

Venue: Courtyard Arlington Crystal City/Reagan National Airport


Director : David Dills

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

  Price: $1,495.00
(Seminar Fee for One Delegate)

  Register for 5 attendees   Price: $4,485.00
      $7,475.00 You Save: $2,990.00 (40%)*

  Register for 10 attendees   Price: $8,222.00
      $14,950.00 You Save: $6,728.00 (45%)*
Course "How FDA Trains Its Investigators and Inspectors to Review Sub-Systems for State of Compliance: What You Need to Do to Prepare for a Successful Inspection" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Senior management takes responsibility for Quality and GXP compliance. It is not something delegated to the Quality unit or to the Regulatory Affairs group. Developing and implementing an effective Inspection readiness plan will help ensure better results, as well as a less stressful inspection. Planning strategically ahead will reduce document turn-around time, improve presentation skills from SMEs, and increase inspector confidence in the Quality System. Successfully completing an FDA inspection is critical to cGMP operations and commercial success. Implementing and maintaining robust quality systems is one element to accomplishing this goal. However, it is not the only element. Inspection preparation and management is another, equally important element to ensure a successful outcome. In fact, proper Inspection Management techniques can help mitigate the risk of receiving an observation for compliance gaps. Quality and GXP compliance are an opportunity, not an obligation, and are owned by everyone in the organization. For those interacting with FDA regarding submissions, as an example, every interaction with the FDA is a crucial moment for your development program, and meetings represent a culmination of compiled and scheduled work. Strategies, timelines, costs and complexity are all organized through this interaction - the stakes are high, and the outcomes are extremely important. It all comes down to strategic communication. Every facet of FDA meetings - from the information your company is providing, to scientific research and the tone and articulation of that information - must be conducted flawlessly. For example, for many medical device companies, a meeting with a US Food and Drug Administration (FDA) Advisory Committee is a high-profile, high-stress event. A successful meeting can assure regulators, patients and investors that a product is safe and effective, while an unsuccessful meeting can torpedo a product's chances of a timely approval.


Why you should attend:

This seminar will offer learning on the following:
  • How a firm should prepare for an FDA inspection
  • Ways to train employees in view of the inspection
  • Field Management Directives
  • Sub-Systems for Pharmaceutical and Medical Devices
  • The emphasis on systems-based inspections...and the IOM, QSIT, CPGM and other crucial FDA reference documents
  • How to ensure that required documentation is in place
  • How to interact with the investigator-DO's and DON'T's
  • What companies should do when the inspection ends
  • Post inspection actions
  • Why inspections are conducted and by what statutory authority
  • The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents
  • Define and execute proven GxP Compliance Strategies
  • Proven Operational Readiness and State of Readiness tactics
  • Determine optimal pathway during inspections and post-inspection correspondence and meetings
  • Identify the visible signs of GXP compliance that are present as a daily reminder of the importance of GXP compliance with "risk-based" awareness demonstrated by companies
  • Improve credibility and trust with FDA and other regulators
  • Important training areas in GxP compliance and topical issues
  • Gain a better understanding of how to interact and communicate effectively with FDA
  • Identify the ground rules and do's and don'ts with FDA inspections
  • Learn what FDA can request and not request during an inspection
  • Understanding the interview process and why pre-inspection planning is critical for your company
  • Navigate the inspection process from preparation, execution to close-out and debrief/exist interview
  • FDA authority and process including 483s, Warning Letters, recalls, and other potential actions
  • The FDA inspection process and approach
  • The use of a mock audit and outside certifying audit
  • Required documentation, format, and archive
  • How to respond to inspection and audit results
  • In a group setting, review and discuss pain points, challenges and workable regulatory and compliance solutions for any FDA inspection
  • Prepare for lively discussions and a mock inspection as part of a classroom exercise
  • Communicate effectively with FDA and reference FDA guidance and other critical resources.

Who will benefit:

This seminar will provide an overview and in-depth snapshot of the entire process for preparing for and managing an FDA inspection and external regulatory inspections and for those companies which must establish proven and sustainable GXP compliance strategies and risk mitigation strategies when responding to a crisis. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the FDA inspection process from preparing for the inspections, during the inspections and post-inspection responsibilities and follow up activities with FDA, including:
  • Executive Management
  • Regulatory Affairs Management
  • Regulatory Affairs Specialist
  • Auditors
  • QC/QC Management
  • Compliance Officer
  • Compliance Specialist
  • Clinical Affairs
  • Quality Assurance Management
  • Marketing & Sales
  • Laboratory Operations
  • Distributors/Authorized Representatives
  • Legal Counsel
  • Engineering/Technical Services
  • Operations/Manufacturing
  • Consultants
  • Individuals who come in contact with regulatory inspectors
  • Auditors
  • Compliance/Regulatory affairs professionals
  • QA/QC professionals
  • Manufacturing managers, supervisors & personnel
  • Project Managers
  • Regulatory Affairs Management
  • Regulatory Affairs Specialist
  • Compliance Officer
  • Compliance Specialist
  • Clinical Affairs
  • Distributors
  • Legal Counsel

Day 1 Schedule


Lecture 1: Introductions and Background


Lecture 2: FDA's Inspectional Authority and History


Lecture 3: FDA Inspection Program Overview


Lecture 4: Key factors for a successful FDA inspection


Lecture 5: Quality System Readiness


Lecture 6: Organization Readiness


Lecture 7: Manage Inspection Outcomes


Lecture 8: Information and Documentation


Lecture 9: How should a firm prepare for an FDA inspection?


Lecture 10: Ways to train employees in view of the inspection


Lecture 11: How to ensure that required documentation is in place


Lecture 12: How to interact with the investigator-DO's and DON'T's


Lecture 13: What companies should do when the inspection ends


Lecture 14: How to reply to 483's and Warning Letters


Lecture 15: Legal implications of non-compliance


Lecture 16: Why inspections are conducted and by what statutory authority


Lecture 17: The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents such as QSIT


Lecture 18: What is subject to FDA purview and what's off-limits


Lecture 19: Understand and apply the do's and don'ts and comprehend that preparation is the key to success


Lecture 20: What are the prohibited "Acts" and the enforcement categories that you need to deal with?


Lecture 21: What you need to know and do to prepare for, during and even after the inspection...and why your inspection response team is key


Lecture 22: The company's Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel


Lecture 23: How to respond to findings and facilitating the documentation and remediation process...and reaching final closure


Lecture 24: Define clear responsibilities, roles and goals for personnel involved in FDA inspections and SOP development


Lecture 25: Exit Interview


Lecture 26: FDA interviewing employees and personnel


Lecture 27: Management Controls, Production and Process Controls, Design Controls, CAPA, and sub-systems



Day 2 Schedule


Lecture 1: Quality System, Facilities and Equipment System, Materials System, Production System, Laboratory Controls and Operations, Packaging and Labeling System


Lecture 2: Maintain, or return to, regulatory compliance and minimize downtime


Lecture 3: Establish a risk management plan in place to proactively manage compliance, including a crisis-management plan


Lecture 4: Set post-inspection deadlines and working closely with FDA's regulatory partners


Lecture 5: Compliance remediation is the process of recognizing problems, creating a plan to correct and prevent them from occurring in the future, and executing to that plan to helps with your GxP Compliance Strategy.


Lecture 6: Guidance outlining clear recommendations for sponsors and for FDA staff and managers as well for Pre-Submission meetings as expected timeframes for scheduling meetings


Lecture 7: Mechanics of requesting any FDA meeting and what you need to know to be successful with communication style, approach and tactics


Lecture 8: Prioritize follow-up on warning letters and other enforcement actions


Lecture 9: Develop and implement a formal warning letter "close-out" process


Lecture 10: Untitled Letter and the Warning Letters


Lecture 11: Recent Trends and Enforcement Actions


Lecture 12: Mock Inspections and Mock Audits and why role playing is important


Recap of Day 1 and Day 2
Exercise on Day 2
  • Interactive Discussions
  • Review Regulatory and Compliance Documentation
  • Recent Enforcement Actions and Emerging FDA Trends
  • Classroom Project: Prepare for and Host an FDA Mock Inspection and Prepare Effective Company Response to FDA 483 and/or Warning Letter


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Group participations
Get fabulous discounts by participating in groups of two or more.
No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on 1800 447 9407 to have your seats confirmed!

David R. Dills

Global Regulatory Affairs & Compliance Consultant and President, NovaQual

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. He 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 applicabilityofFDA regulations,including 21 CFR 210/211, 820 QSR/cGMP, Quality System implementation and compliance requirements, GxP training, leads and directs activitiesfor the registration and approval process andworking 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 bythird-partyconsultancies and provides services involving all phases ofthe 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; 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, Postmarketing Surveillance and Vigilance Reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO13485 registration and CEMark; andmulti-countryproduct 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, CTD/CMC 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; conducts MDSAP training; 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; assist companies during FDA and other regulatory authorities' 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; conductspersuasive communication with regulatoryauthorities;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 withregulationsin The Americas, EMEA 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 andBiology.Heis aformer Chair and Co- Chair of ASQ's Section 1506 and associated with the BiomedicalDivision,RAPS,AdvaMed, PDA, ISPE, and other industry working groups.

Location: Washington, DC Hotel: Courtyard Arlington Crystal City/Reagan National Airport   2899 Jefferson Davis Highway Arlington, VA 22202 USA

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