Offered when and where you need it...
√ Understand how and where FDA holds Management responsible for producing safe and effective products
√ Learn who FDA considers as "Management" and the consequences of Management not fulfilling their roles
√ Examine procedures and tools to demonstrate compliance, including Management Reviews, Audits, Training and more
Management responsibility – to establish and review a quality system, to provide adequate resources, to select and monitor suppliers, and more – is the cornerstone of FDA’s approach to Quality System regulation and compliance with the Food, Drug and Cosmetic Act (FD&C).
But what exactly does FDA expect from management? And who’s considered “management” anyway?
When FDA visits your facility, how do you prove to the inspector that management is meeting its responsibilities? Get the answers you need from Martin Browning, a 22-year veteran FDA investigator and the co-developer of FDA's Quality System Regulation (The "QSR" -- 21 CFR Part 820) and other rules and policies while serving at FDA Headquarters. Martin is the president and co-founder of EduQuest, a global team of FDA compliance experts, and one the nation's most sought-after advisors to FDA-regulated companies.
At the Briefing, your Management Team will learn:
Key FDA laws and regulations underscoring the importance of Management Responsibility
Management's specific roles in a compliant and effective Quality System
What FDA expects you to cover in your Management Reviews, Quality Audits, and Training Programs
Management responsibilities for supplier selection and qualification
Practical guidance for preparing for and managing an FDA inspection
What happens when Management drops the ball -- the consequences of non-compliance
Recommendations for success from an internationally recognized industry trouble-shooter and advisor
Examine The Management Responsibility Briefing curriculum
Review the qualifications & experience of the Briefing Leader
Get more information -- and learn how to schedule the Briefing at your facility
for Quality Systems:
FDA Expectations for Management Controls, Adequate Resources, Quality Audits and More
Delivered in 2-Hour or 4-Hour Formats, depending on your Management Team's needs and availability
What Executives Need to Know about the U.S. Regulatory Framework for Food, Drugs and Devices
The FD&C Act: Foundation for All Management Responsibilities
Strict Liability Statute: No Excuses for Violating the Law
The "Muscle" -- Laws and Court Decisions Upholding FDA Inspection and Enforcement Powers
How FDA Guidance Differs from (and Relates to) FDA Regulation
The Most Important Quality System Concepts
What does FDA Consider a Quality System? How does FDA's Viewpoint Compare with ISO's?
Purpose of a Quality System: Assuring Compliance with Current Good Manufacturing Practices (cGMPs)
Key Roles of Management in a Quality System
What Does It Mean to Establish an "Appropriate" Quality System?
The Quality System Regulation: FDA's Clearest Statement of Agency Expectations
Differences between Quality and Compliance
FDA's Lifecycle Approach: Cradle-to-Grave Quality
Overview of QSR Requirements
Quality Policy, Objectives, and Plans: What They Should Include
"Basic" Management Controls: Overview of What FDA Expects
Who is Considered Management?
Role and Responsibilities of the Management Representative
Establishing an Adequate Organizational Structure
Review and Approval Duties
Management Controls: Specific Requirements and Tools to Demonstrate Compliance
Conducting Management Reviews: Who, How Often, What to Cover
Can FDA Access the Results of Your Reviews?
Quality Audits: Objectives, Scope, How Often to Conduct Them
Can FDA Access the Results of Your Quality Audits?
Management Controls: Specific Requirements (cont'd)
Providing Adequate Resources: Staffing, Money, and More
Management's Role in Identifying and Meeting Employee Training Needs
Management's Role Establishing Purchasing Controls
Management's Role in Selecting and Assessing Suppliers
FDA's Inspection Methods, including the Quality System Inspection Technique (QSIT)
Importance of Demonstrating Objective Evidence
The Seven Quality Subsystems You Should Know
The Core Subsystems Targeted in Most FDA Inspections
Management's Role in Preparing for and Responding to FDA Inspections
The Consequences of Non-Compliance
FDA's Enforcement Arsenal: Fines, Product Seizures, Consent Decrees, Criminal Prosecution and More
Examples of Impact of FDA Enforcement on Shareholder Value
Differences between FDA 483s and Warning Letters -- and How to Respond to Each
Common Pitfalls: Frequent FDA Warning Letter Citations related to Management Control
Tips and Recommendations for Success
Importance of Accurate and Thorough Documentation
Ensuring Continuous Monitoring, including Rigorous Supplier Assessments
Global Corrective Actions -- Ensuring Problems in One Facility Don't Carry Over to Others
Integrating Risk Identification, Assessment and Mitigation with Your Quality System
Questions & Answers/Discussion with Focus on Specific Company Needs and Priorities
EduQuest is a global team of FDA compliance experts headquartered near Washington, DC. Celebrating its 20th year of service to FDA regulated industry, EduQuest was founded in 1995 by three former FDA rule-makers and expert field investigators.
Since that time -- with hundreds of training classes and consulting assignments worldwide -- EduQuest has helped thousands in the medical device, pharmaceutical, biologics, food and tobacco industries better understand FDA expectations, prepare for FDA inspections, resolve FDA enforcement disputes, and upgrade their Quality Systems to world-class standards.
"Unsolicited plug: EduQuest seminars are excellent! If you can attend, you should. I've been to several of your seminars over the years, enjoy them, and always leave with a pile of new information." (Doug Finner, Elbit Systems)
About Your Briefing Leader:
22 Years of Experience at the FDA; 20+ Years Advising Major Drug and Device Firms Worldwide
President of EduQuest
22 years as an FDA investigator, Office of Regulatory Affairs (ORA) senior official, and contributor to the original Part 11 and Quality System rules.
Martin Browning is the President and Co-Founder of EduQuest, a global team of FDA compliance experts based near Washington, D.C. He has more than 30 years of hands-on experience at the FDA and as a highly sought-after advisor to industry.
His 22-year career at FDA included work in the field offices as an investigator and in FDA headquarters as a senior manager in the Office of Regulatory Affairs (ORA). He capped his FDA career by serving as a special assistant to the Associate Commissioner for Regulatory Affairs.
Martin also served as vice chair of FDA’s electronic record and signature working group, where he helped to draft the original 21 CFR Part 11 regulations. In addition, he served as the chair of the U.S. government’s ISO 9000 committee and was a member of the FDA committee that developed the medical device Quality System Regulation (QSR) -- 21 CFR Part 820.
At EduQuest, Martin helps clients solve problems related to FDA regulation, quality assurance, management control, software and systems engineering, and compliance auditing, including assessing vendors and outsourced operations. Martin was named Speaker of the Year by the Institute of Validation Technology (IVT) and has received dozens of other awards from the FDA, DIA, ASQ, and other industry organizations.
“Martin has a wealth of knowledge when it comes to the FDA and how to answer their questions and address their requests. Many of the experiences he shared were very insightful and something we can take back and share...” (W. Odeh November 2016)
“Martin Browning has a wealth of FDA/industry knowledge, and it is apparent in his examples and conversation he has so much good advice and insights to share. Very credible and yet approachable speaker! Enjoyed his class greatly.” (S. Gillham November 2016)
“Mr. Browning uses his past experience as an FDA inspector to give an accurate insight into the FDA perspective and to cite proper examples from his own experience, which helps to put some of the regulations and expectations into better context.” (Quality Manager, AstraZeneca)
“Martin…provided a real sense of what the FDA is looking for today with regard to management of an outsourced supplier. He was easy to follow and very clear in his explanations….” (Account Manager, Neutrogena Corp.)
“Mr. Browning’s experience and presentation style were very good. He had great insight into what the FDA expects, and he provided good guidance for companies to move forward on those expectations.” (Senior Facility Auditor, Covance Laboratories)
Get More Information:
FDA Expectations for Management Controls, Adequate Resources, Audits, and More
This Briefing can be delivered directly at your facility, when and where convenient for you and your Management Team.
Cost is $7,500 per Briefing, plus travel expenses. For up to a maximum of 20 people, Briefing participants receive printed materials with copies of the slides and other presentation materials.
The Briefing can be presented in blocks of two-hours or four-hours (recommended), depending on the schedule and availability of your Management Team. Most common schedule is 8:30 a.m. - 12:30 p.m. with one or two 15-minute breaks.
Ample time for Questions & Answers/Discussion and personal consultation can be included in the Briefing schedule or immediately afterwards.
To check secure a date on Martin Browning's schedule, email Info@EduQuest.net.
Or call +1 (301) 874-6031 between 9 a.m. and 5 p.m. Eastern U.S. Time.
Need on-going information and advice from the FDA compliance experts at EduQuest? Subscribe to EduQuest’s free monthly newsletter delivered by email, EduQuest-ions & Answers. Click here to subscribe.
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