2 days seminar : Strategic Compliance and Risk Management: GXP Compliance Strategies, FDA Inspections and State of Readiness and Assistance during Inspections/Post-inspection Correspondence & Meeting

By: David R Dills, Regulatory Affairs & Compliance Consultant.
Product code: SEM24
Location 1: Boston,MA Jul 13 - 14


Course "Strategic Compliance and Risk Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

"Each attendee will receive 2-Day workshop materials by the speaker. Seminar Also Includes Certificate, Complimentary Breakfast, Lunch & High Tea/Coffee provided by WCS"

Non-compliance is an expense that no healthcare company can afford. Companies must establish proven and sustainableGXP Compliance Strategies and risk mitigation strategies when responding to a crisis so you avoid costly product approval delays, recalls and adverse impacts on shareholder value, including FDA enforcement actions. Companies must adopt a risk-based approach to managing quality and regulatory compliance not only for GCP, GLP and GMP but across the entire platform. Whatever solution you are using it needs to provide a common framework and an integrated approach to meet FDA GxP regulations through effective risk management, document control, compliance training, ongoing auditing, surveillance and monitoring activities and other critical areas that will be addressed during the seminar. 
This is a practical, hands-on two-day seminar designed to provide pharmaceutical, biopharmaceutical, biologics and medical device professionals with the information and tools they require to prepare for and manage an FDA inspection efficiently, effectively and successfully. 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 seminar 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, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters.
The course will go through what typically goes on during an FDA Inspection and will then cover how to prepare for, host and follow up to a regulatory inspection. It will emphasize and focus on the critical and vital elements that you should do or not do during the inspection. Typically, FDA inspections can be highly structured and there are procedures that are to be followed as you prepare for state of readiness. It is important for anyone who might be involved in the inspection to be aware of these procedures, including all employees and personnel to ensure there are no surprises. 

Areas Covered

•    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
•    Improvecredibilityandtrust    withFDAand    otherregulators
•    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

Who will Benefit

•    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

Learning Objectives

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. 

Course Outline:

Day 1 

•    Introductions and Background
•    FDA’s Inspectional Authority and History
•    FDA Inspection Program Overview
•    Key factors for a successful FDA inspection
•    Quality System Readiness
•    Organization Readiness
•    Manage Inspection Outcomes
•    Information and Documentation
•    How a firm should prepare for an FDA inspection?
•    Ways to train employees in view of the inspection 
•    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 
•    How to reply to 483's and warning letters 
•    Legal implications of non-compliance 
•    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 
•    Define clear responsibilities, roles and goals for personnel involved in FDA inspections and SOP development
•    Exit Interview
•    FDA interviewing employees and personnel


Day 2

•    Maintain,orreturn to, regulatorycompliance and minimizedowntime
•    Establish a risk management plan in place toproactivelymanagecompliance, including a crisis-management plan
•    Set post-inspection deadlines and working closely with FDA’s regulatory partners
•    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. 
•    Guidance on how to request and conduct PDUFA meetings and expectations for Sponsor-FDA Meetings
•    Guidance outlining clear recommendations for sponsors and for FDA staff and managers as well for Pre-Submission meetings as expected timeframes for scheduling meetings
•    Mechanics of requesting any FDA meeting and what you need to know to be successful with communication style, approach and tactics
•    Prioritize follow-up on warning letters and other enforcement actions 
•    Develop and implement a formal warning letter “close-out” process
•    Untitled Letter and the Warning Letters
•    Recent Trends and Enforcement Actions for 2017 
•    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 for 2017 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




David R DillsRegulatory Affairs & Compliance Consultant

David R. Dills,Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities involving consent decrees, CIA’s, warning letters, and customer generated compliance events, conducts QS, regulatory, compliance assessments/audits and FDA Mock Inspections for State of Readiness. 

He has been directly involved with constructing, reviewing, and remediating regulatory submissions, U.S. Agent for OUS companies, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs/CTM and provides regulatory submissions and post-market project leadership and guidance covering multiple therapeutic and medical specialties based on classification. He has a strong background in the interpretation and applicability of FDA and international regulations, leads activities for the registration and approval process and working with the Agencies in Asia Pacific, EMEA and The Americas, including FDA, European Medicines Agency–EMA, MHRH, ANVISA, PMDA, MOH, CFDA, TGA, and Health Canada and works with management on regulatory strategies and plans supporting a company’s commercialization strategy. He directs and leads efforts for PM support involving all phases of the premarketing to postmarketing; establishes Medical Device Single Audit (MDSAP), UDI, and Digital Marketing/Promotion/Advertising compliance strategies; lead efforts regarding AE/Incident Reporting, all aspects of Postmarketing Surveillance and Vigilance Reporting; establish QMS and documentation systems for GxP compliance; ISO 13485 registration and CE Mark, Technical File, Design Dossier and CER consultation; and facilitates multi-country product registrations and licensing. 

He 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; regulatory oversight and governance; design controls; CAPA investigations; GxP training; software embedded medical devices/all aspects of SW/SDLC and process validation with compliance oversight; supplier management; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure. 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 affiliated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working group

13-July-2017 To 14-July-2017 Boston,MA
Seminar One Registration
$ 1295

Special Group Discount Register for Four attendees
$ 3885

Please call any of our customer support on 844-267-7299 to avail the below discount for your Group

2 Attendees - 2% off

3 to 6 Attendees - 5% off

7 to 10 Attendees - 7% off

10+ Attendees - 15% 0ff

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Hilton Garden Inn Boston Logan Airport $169 / Night

Address: 100 Boardman St, Boston, MA 02128, USA

Phone: +1 617-567-6789

How to Reach


I have attended various seminars from WCS but this "Live" one was incredible. This seminar was excellent.

Pfizer Quality Manager

I liked WCS training style. WCS speakers gave excellent examples to back up what speaker was explaining. Which helped me grasp a better understanding."

RA/QA Manager Abbott

The presenter was excellent session leader, very knowledgeable and well-spoken. The topic was well chosen and interaction between the participants and the presenter was good.

Chief Compliance Officer

This was an informative seminar. Provided very valuable insight into how the FDA works. Presenters' experience in real life events and interaction with the FDA is priceless.

Quality Assurance Medtronic

“I enjoyed the training, the instructor was engaging and were able to modify the course to make it more applicable for small group.”

Peter Belsito, Director of Quality TSI

Awesome material covered.  Andbero Magleo, IT Admin Passy-Muir

“Very informative with enough details to start putting together action plans. Susan Murphy, Associate Director, Quality investigation (QA) LFB USA

“I learned a lot from the instructor and trainee good.” David QU, senior Analytical Chemist Dalton Pharma Services.


“Well placed, a lot of good information. Good interaction between participants. Held at a good location. More was US based examples given.” Nicola Mootoo, Senior Validation Engineer Shire Pharmaceuticals


“Well delivered seminars, right place, good contents.” Evelyn Chang, Corporate manager Genzyme.

“I though the contents of the presentation and the discussion was very good.”Mary Beird, Regulatory Compliance Manager Charles River laboratories International, Inc.


“Great session. I learned a lot” Chief HR Professional"

“Wow!  I had an opportunity to attend the HR audit workshop.  It is spectacular and I found it very valuable.
It will help us audit and manage strategic HR issues.” The president of a major insurance and risk management agency.

“I found the audit session very useful; it will help us identify and manage key HR management issues.” A senior auditor

“The session provided important information about HR auditing. It will help us audit critical HR issues and outcomes
 and will help us assess the organization’s culture and values.” A Chief Internal Auditor

“I’ve been doing a lot of research lately on HR audits, trying to find the best system for us.
This session and ELLA seems to really fit the bill for us.” A human resource manager


Media Partners

Top Media Partners and Sponsors World Compliance Seminars WCS


Morf Media, Inc. is shaping the future of enterprise compliance training for the mobile workforce. For the first time, a digital compliance training system, Morf Learning™, provides one to one training to millions on a smart phone or tablet. Now in pilot with more than 100 major companies in the financial services and life sciences industries, Morf Learning is proving to be cost-effective and engaging. Morf Learning delivers three-minute mini lessons with a personalized Virtual Coach™ developed using the Octalysis framework designed by world-renowned gamification leader, Yu-Kai Chou. 


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Listing in monthly Community Leader newsletter sent to over 50,000 users. 

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$4,000 - Silver Gold Package Includes

Company name and logo on all materials related to events, and prominent location on WCS web site and event media releases 

Listing in monthly Community Leader newsletter sent to over 50,000 users. 

2 Free Pass for the 2 Day Workshop

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15-20 minutes product demo during the live session

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