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Are these risks lurking in your supply chain?
Don't wait for the FDA to find these soft spots — take charge of your outsourcing today with this 12-hour training class from the experts at EduQuest, including former FDA investigator and noted supply chain expert, Martin Browning.
You can't outsource your quality responsibility. The FDA says so, without exceptions. No matter how many vendors contribute to your finished product, you are ultimately accountable for keeping FDA and your customers satisfied.
Through recalls, seizures, injunctions, and more, FDA has considerable reach up and down your supply chain. To protect yourself and your shareholders, you need to identify and fix the weak spots in your outsourced operations today.
Start by attending this highly focused, actionable training program offered by EduQuest – a global team of FDA compliance experts headquartered near Washington, DC. Expert instructors with more than 30 years of experience as FDA investigators, rule-makers, and industry advisors will help you understand your regulatory requirements and spot problems before they compromise the safety and effectiveness of your products.
In less than two days, learn how to:
· Measure and monitor supplier quality systems, processes and documentation
· Ensure you and your suppliers have the right records to respond to FDA and external auditors
· Improve supplier management using your existing CAPA program
· Identify links in your supply chain you should and must audit
· Deploy in-person audits, third-party audits, or remote monitoring – and understand the pros and cons of each
· Use FDA’s Quality System Regulation (QSR) as the benchmark for effective management reviews, material control & more
· Comply with ISO standards and FDA’s QSR, knowing the overlaps and differences between each
· Think like an FDA investigator and recognize your greatest risks and vulnerabilities
· Implement contracts and SLAs that set clear expectations and responsibilities
· Operate within a defined and documented state of control throughout your supply chain
Managing & Auditing Supplier Quality will help you select, audit and monitor outsourcing partners to ensure quality problems are contained and harmful products don't reach patients. If you’re a supplier yourself, you’ll learn how to meet FDA’s expectations and become a more attractive business partner.
Who Should Attend:
This course is designed for representatives of both OEMs and suppliers, especially those with the following responsibilities:
Managing & Auditing Supplier Quality
FDA Expectations * Global Standards * Real-World Solutions
Day 1: 8:30 a.m. – 5:30 pm; Day 2: 8:30 a.m. – 12:30 p.m.
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.
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 -- through 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, May 2011)
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.
“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 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.”
“[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.”
“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.”
"Well presented, with a wealth of information."
"[I liked] the industry experience of the instructors. Open communication and dialogue, plus applicable 'real time' examples were shared."
"The instructors were great -- very knowledgeable and experienced. They were very willing to discuss specifics and answer questions. Both obviously know the industry and regulations very well. I expect the resource materials will be helpful as well."
"It was very helpful and I took several ideas back to my company that will become part of our supplier management program."
Latest Schedule of Course Dates:
Managing & Auditing Supplier Quality
FDA Expectations * Global Standards * Real-World Solutions
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