Course Curriculum:

Day 1: 8:30 am – 5:00 pm

Day 2: 8:30 am – 1:00 pm

• The Big Picture: FDA and ISO Requirements for Managing Suppliers
  • Why supplier management is a high priority at FDA
  • FDA’s regulatory authority and enforcement tools
  • Inter-relationship of ISO and FDA requirements
  • Introduction to FDA’s 7 subsystems of a compliant Quality System
• Contracting with Suppliers: Establishing Expectations and Accountability
  • Three types of processes you should never hand off to a third party
  • Vendor qualification: tips for selecting suppliers who have a culture for compliance
  • How to define and document each party’s responsibilities
  • Monitoring and auditing provisions to include
• Role of a Quality System in Managing Suppliers
  • Crucial elements your Quality System must include
  • Quality management principles under ISO
  • Definitions of key terms and concepts
  • Incorporating suppliers into your CAPA program
• Integrated Auditing Techniques
  • Differences between auditing and monitoring – know which is appropriate when
  • Setting realistic goals and strategies for supplier quality audits
  • Linking the mindset of FDA inspectors with your auditing SOPs and techniques
  • Objective Evidence: recognizing the gold standard of auditing and compliance
• Tips and Requirements for Auditing Management Control
  • Management responsibility and reviews: the core of FDA’s expectations
  • What to include in your quality policies and procedures
  • Role of internal audits…and the critical importance of audit follow-up
  • Examples of FDA Warning Letters citing management control failures
• Tips and Requirements for Auditing CAPAs and Non-Conformances
  • What FDA looks for in your CAPA system
  • Potential sources of CAPA information
  • Auditing non-conforming materials, complaints, and MDRs
  • Examples of FDA Warning Letters citing CAPA and root cause investigation failures
• Tips and Requirements for Auditing Production and Process Control
  • Importance of Device Master Records and Device History Records for effective design transfer
  • FDA expectations for process control and validation
  • How responsible are you for ensuring adequate training at your suppliers?
  • Examples of FDA Warning Letters citing Process Control failures
• Tips and Requirements for Auditing Records, Documents, and Change Control
  • FDA rules for electronic records and signatures
  • Expectations for validating computerized systems
  • Critical importance of audit trails
  • Examples of FDA Warning Letters citing documentation and change control failures
• Tips and Requirements for Auditing Facilities and Equipment Control
  • Documenting and calibrating inspection, measurement and testing equipment
  • Tools and techniques for monitoring contractor validation programs
  • Role of environmental monitoring
  • Examples of FDA Warning Letters citing Equipment Control failures
• Tips and Requirements for Auditing Material Control
  • Documenting supplier status and establishing purchasing SOPs
  • Acceptance activities: ensuring incoming products meet specifications
  • Traceability: documenting units, lots and batches
  • FDA expectations for material shipping, labeling, handling and storage
  • Examples of FDA Warning Letters citing Material Control failures
• Tips and Requirements for Auditing Design Controls
  • Differences between design verification and design validation
  • Defining and documenting essential design inputs and outputs
  • Ensuring accurate transfer of product design to production
  • Examples of FDA Warning Letters citing Design Control failures
• Regulatory Enforcement: The Consequences of Non-Compliance
  • Helping your suppliers prepare for an inspection or audit
  • Can you shield your audit reports from FDA?
  • Responding to 483s and Warning Letters
  •  Latest FDA enforcement priorities and targets

Interactive Exercises to Apply and Retain Your Learning:

FDA Expectations for Managing & Auditing Supplier Quality will offer engaging and informative exercises designed to help you apply the course concepts, terms and tools to real-world problems you’re likely to face with suppliers, customers, and contract manufacturers. Exercises will focus on solving real-world problems (including ones cited by the FDA inspectors) and mitigating common risks that can occur throughout your supply chain.

About Your Instructors:

More than 50 Years Combined Experience at the FDA

and Serving as Expert Advisors to Industry

Martin Browning, President of EduQuest 22 years as an FDA investigator, Office of Regulatory Affairs (ORA) senior official, and contributor to the original Part 11 and device 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 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).   At EduQuest, Martin helps clients solve problems related to FDA regulation, quality assurance, software and systems engineering, and compliance auditing, including assessing vendors and outsourced operations. He spearheads EduQuest SupplyCheckTM Service, designed to help clients establish a corporate or facility-wide supplier selection, monitoring, and auditing process. 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.   “Unsolicited plug: EduQuest seminars are excellent! If you can attend, you should. I’ve been to several your seminars over the years, enjoy them, and always leave with a pile of new information. If you can get your management and IT staff to attend, you should.” (Elbit Systems, May 2011)   “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 for outsource, and he provided good guidance for companies to move forward on those expectations.” (Senior Facility Auditor, Covance Laboratories)

Janis Olson, EduQuest 22 years as global FDA investigator and regional office director; certified ARC/PDA Auditor

Janis Olson is a Vice President of Quality and Regulatory Services with EduQuest. Previously, she worked at FDA for more than 22 years, where she conducted domestic and international inspections and capped her Agency career as the Director of the Information Resources Management Office in FDA’s Southeast Region. Currently, Jan helps EduQuest clients comply with GxP regulations and apply risk management concepts and tools to meet FDA’s expectations and international standards. She also helps clients prepare for FDA inspections through training, writing and updating SOPs, and reviewing computer validation documentation. She has chaired PDA’s Industry Review Board for the Audit Resource Center (ARC) and was on the PDA task force that wrote Technical Report 32 on Computer System Supplier Auditing. Jan is certified as an ARC/PDA auditor and was a member of the PDA task force that wrote the Good Electronic Records Management (GERM) document.   “Great course! My organization has experienced being under the microscope lately due to FDA warning letters and 483s being issued to our clients who transferred their obligations. This will give us a starting point for a robust risk management process.” (Introduction to Risk Management for FDA Compliance course, September 2010, Wilmington, DE)   “[I enjoyed] the ability to receive information directly from a former FDA investigator. It was also good to hear the Q/A from various individuals from various locations and companies.” (April 2009)   “Very knowledgeable, experienced instructors. Excellent teaching techniques, had answers to all our questions.”   “All the instructors are knowledgeable, articulate and dynamic. The instructors are the most valuable part of the course.”   “Historical knowledge of the instructors and stories they were able to share in order to drive points home was invaluable.”

2012 Course Schedule:

Dates and Locations to be Determined. Call +1 (301) 874-6031 to be added to mailing list

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Class registration is easy. To enroll or get more details:

Email Martin at Info@EduQuest.net or call +1 (301) 874-6031. Tuition for FDA Expectations for Managing & Auditing Supplier Quality is $1,495.

Register 4 students and send the 5^th student free. Significant discounts also are available for teams of 2 or more from the same company who register together.

Date and location don't fit your schedule?

On-site, on-demand training is available when and where you need it

This course can be delivered directly at your facility, when and where convenient for you and your colleagues. Request a price quote from ClarenceDanielson@EduQuest.net.

 RETURN TO EDUQUEST COURSE OVERVIEW PAGE HERE

EduQuest: EDUcation: QUality Engineering, Science and Technology       www.EduQuest.net      +1 (301) 874-6031