October 9-10, 2018

Medical Device Complaint Management
Waltham, MA

When it comes to QMS and complaint management, device and diagnostics firms face a welter of confusing, sometimes conflicting regulations from the FDA, the EU and Canada. And you don’t dare let your guard down, at the risk of a warning letter … or worse.

FDAnews and OMBU Enterprises LLC have teamed up to help you untangle these vexing problems. It’s a roll-up-your-sleeves interactive workshop in the heart of Boston, conducted by top-rated presenter Dan O’Leary. Over the course of two full days of learning and networking, jam-packed with case studies and exercises developed specially for this workshop, you’ll gain insight into how to keep the regulators happy from here to Brussels and beyond:

  • The regulators: The FDA, Canada, the EU current state and the EU future state … how they’re similar, how they differ
  • The role of QSR, ISO 13485:2016, ISO 14971:2007, and national and regional variants
  • The many definitions of complaints: And their implications
  • Warning letters: What they teach you
  • Process flow and decision points for U.S., EU and Canadian regulators
  • Adverse event reporting: Decisions and timelines
  • Trend reporting to regulators: Understanding the systems
  • Field actions and associated regulatory reports: How to spot the triggers
  • Design changes that trigger the need for updated submissions
  • Recognize when a design change triggers an updated regulatory submission
  • QSIT and the MDSAP Audit Model: How regulators use them
  • And MUCH more!

For details and registration, Click Here

October 23-25, 2018

FDA Inspections Summit - 13th Annual
Bethesda, MD

Mark your calendar for the 13th Annual FDA Inspections Summit taking place Oct. 23-25, 2018 in Bethesda, MD. The Summit is THE place to hear from current and former FDA officials and top industry experts. The program is coming together nicely and will include specialized tracks for:

  • Medical Devices
  • Pharmaceuticals
  • Clinical Trials

Testimonials from Past Attendees:

  • “Great discussion and knowledgeable panel. I enjoyed having the FDA give examples in their own words…” Dan Lewis, Site Quality Leader, P&G
  • “The panels were great. Very informative and great discussions.” Nancy Carranza, Vice President, Operations, GSMS, Inc.

For details and registration, Click Here

November 1-2, 2018

SOPs and Policies for the 21st Century
Why Less Is More

A well-written procedure is written to direct staff and designed to be followed.

Policies and procedures act as a foundation, but one that's flexible like a car's frame and suspension, on which compliance can be achieved confidently and consistently.

And yet — many compliance pros write procedures for the auditor, and not the person who actually has to follow it. Is it more important for the once a year auditor to be happy or for the everyday person to consistently follow the SOP?

While a good SOP helps you demonstrate your compliance and say to inspectors and auditors alike: “We know what we are doing — and why,” the modern SOP enables your business and your compliance success.

In today's busy, stress-filled workplace, your staff needs (and hopes for) SOPs that are easy-to-follow, quick reads. Even regulatory investigators support that idea, saying: “It’s better to have an easy-to-read process map that you can actually follow than to have a detailed SOP that you don’t.”

Yet, in 2017, "inadequate SOPs" was once again a Top 5 most-frequently-cited FDA non-compliance observation.

You can do better. In fact, you must do better.

Take your first big step toward crafting more effective, compliant SOPs.

Attend this highly-interactive, two-day workshop that will teach you down-to-earth, practical techniques you need for writing fast, flexible and compliant SOPs — SOPs that will meet regulatory requirements and today’s globalized expectations.

Plan Now to Attend and Learn from An Award-Winning Compliance Expert

This two-day workshop will be led by John Avellanet, an award-winning FDA compliance expert known for his business-savvy, pragmatic advice and engaging speaking style.

Prior to founding his lean compliance consulting firm, Cerulean Associates LLC, John was a former Fortune 50 combination device C-level executive who created, developed, and ran his company’s compliance programs to achieve ISO, DEA, BIS and FDA compliance.

Over the past decade, he has been interviewed on public radio programs, in numerous industry magazines and multiple news outlets. He speaks frequently for industry conferences and private corporate workshops.

A former FDA and US DOJ prosecutor has said of John Avellanet, “He is the best in the business. Period.”

What You Will Learn

Not only does this workshop provide you an opportunity to hear from an acknowledged expert in SOPs, but you'll also share experiences and learn from your fellow attendees who are confronting the same issues as you. Attend this critical workshop and you'll find out:

  • How to quickly parse warning letters and Form 483s for SOP expectations
  • What FDA investigator questions to expect about your SOPs and policies
  • How to take advantage of the Policy-SOP-Task Outline hierarchy
  • How to use forms, checklists, and templates to reinforce compliance
  • Where definitions belong in the era of wikis and intranets
  • Why FDA, your staff and your management like to see process maps
  • Simple metrics that work for SOPs and policies
  • How to best use photographs in SOPs
  • What mistakes to avoid in your “SOP of SOPs”
  • How to write an SOP to oversee an activity you’ve outsourced
  • Tips on writing for a line worker
  • Tips on writing for an office worker
  • Tips on writing for scientists and engineers
  • Tips on writing for management

For details and registration, Click Here

November 14-15, 2018

Conducting Advanced Root Cause
Analysis and CAPA Investigations

Creating an FDA-proof investigation and CAPA isn’t easy.

What if you can’t define a definitive root cause?

What is the relationship between root, contributing and proximal causes to corrections and corrective actions?

What if you could turn to an industry leader who knows exactly what to do?

Well, you can.

Jim Vesper — Director, Valsource Learning Solutions — has more than 25 years of GMP and investigation training experience, and he will provide you with invaluable insights in root cause analysis and CAPA investigations.

Join FDAnews and Jim — Nov. 14-15, 2018 in Princeton, NJ — for an in-depth discussion on how to improve your skills in performing investigations and identifying effective CAPAs by understanding the underlying “whys” and “how-tos”. In this year’s Conducting Advanced Root Cause Analysis and CAPA Investigations workshop, you will:

  • Discuss the expectations that GMP regulatory authorities have of investigations, CAPAs and investigation reports
  • Describe how accident/incident models can be used when conducting an investigation
  • Differentiate between 6 different accident/incident models
  • Differentiate between root cause, contributing causes and proximal cause
  • Discuss why human error is not a valid root cause
  • Discuss a model that can be used to illustrate multiple layers of control and mitigation
  • Identify 4 different audiences of investigation reports and what each is expecting to see
  • Identify the different sections of an investigation report and what each section should include
  • Given an investigation report with deficiencies, identify ways to improve the report

Space Is Limited, Click Here to Register Today

November 14-15, 2018

Clinical Trial Risk And Performance management Summit

Technological advancements are making it easier to collect, aggregate, and report risk and performance data.

Are you now inundated with information? And unable to focus on what really matters?

Clinical trial leaders in every biopharma company are struggling with these questions. Some are ahead of others, but few have mastered the art of turning metrics into process perfection.

Find out how to put the technological advances to work for you.

Come to Princeton Nov. 14 and 15 for the first-ever Metrics Champion Consortium Summit. This will be an exclusive gathering of the top minds in trial performance metrics, spearheaded by MCC Executive Director Linda Sullivan. Our keynote speaker will be Ken Getz, Associate Professor, Director of Sponsored Programs, Tufts CSDD and Founder and Board Chair, CISCRP, clinical trials guru, founder of CenterWatch and an MCC partner. Linda and Ken and our roster of experts will guide you through the issues that are top of mind in clinical trials metrics today:

  • How is ICH-E6(R2) changing what you need to measure? What are global regulators looking for?
  • How do metrics influence behavior? Are you rewarding firefighting or preventing problems? Does your staff have the critical thinking skills needed to root out what needs to be changed?
  • Centralized monitoring. How is industry approaching key risk indicators and quality tolerance limits?
  • Getting to the root of the problem. Pros and cons of traditional analytic approaches: Is there a better way?
  • Predictive analytics. The next-level key to your success. But how do you get there?

    The Clinical Trial Risk and Performance Management Summit is interactive. You’ll roll up your sleeves with speakers and fellow attendees as you tackle case studies that will bring clarity to the metrics process — and provide you with the answers you need.

For details and registration, Click Here

December 10-12, 2018

Design of Medical Devices Conference, China 2018
Location: Beijing Int'l Convention Center
Beijing, China

The University of Minnesota Earl E. Bakken Medical Devices Center, along with its partner Neos Discovery Capital, held the first ever DMDC in November 2017 with important sessions held by the China FDA, US FDA, leading med device companies, and leading academic institutions. This year the event is being held Dec 10 – 12 at the Beijing International Convention Center in Beijing, China.

The event will once again feature live surgery, input from leading FDA officials (China and USA), discussions on the merging of devices with AI, new technology applications, the applications of Med Devices to world and rural health, and similar topics. This year we are expect 1,000 attendees in Beijing with exhibitors and contributors from many nations. A strong delegation from Africa is expected at the event. The DMDC event is quickly becoming a strong international meeting place for the Med Device Industry, Researchers, Regulators, and Academia. The 2017 participants included Abbott, Boston Scientific Corporation, Medtronic, Johnson & Johnson, Worrell and many others.

Register online today

April 15-18, 2019

18th Annual Design of Medical Devices Conference
Graduate Minneapolis & McNamara Alumni Center
Minneapolis, MN

The University of Minnesota’s Medical Devices Center (part of the Institute for Engineering in Medicine), the College of Science and Engineering, and the Department of Mechanical Engineering presents the 18th Annual Design of Medical Devices Conference, April 15-18, 2019. The world's largest medical device conference will be held at Graduate Minneapolis & McNamara Alumni Center, located on the University of Minnesota Twin Cities Campus. The DMD Conference brings together medical device designers, manufacturers, researchers and representatives from academia and the public sector.

Conference Goals

  • Provide a national forum to bring together world-class medical device designers, researchers, manufacturers, and the public sector to share perspectives and innovations in medical device design,
  • Showcase the University of Minnesota as a leader in the medical device community, and
  • Raise funds from corporate sponsorship to support medical device education at the University of Minnesota
Call for Papers

The DMD 2019 Conference seeks original papers that demonstrate new technologies and applications in the field of medical device design. Submissions from academic and industry researchers, clinicians and practitioners are encouraged. Papers should present an unbiased description of an experiment, product or business method related to medical devices. Repeated references to branded products or trade names, or excessive use of corporate logos or trademarks in illustrations is discouraged. Authors of contributed papers are likely to be asked to serve as reviewers.

A number of papers will be selected to be presented in one of the Advances in Medical Devices sessions and ten papers, describing medical device designs with a potential for commercialization, will be invited for participation in the Three-in-Five Competition.

All accepted papers will be published in the 2019 Proceedings of the Design of Medical Devices Conference in the ASME Digital Collection. DMD Conference registration and presentation of the paper in the conference poster session is required for publication of the paper.

High-quality accepted papers will be flagged in the review process and those authors will be invited to submit a longer version of their work for publication in the ASME Journal of Medical Devices. These papers will undergo an expedited review process, handled by the JMED editors.

November 1, 2018 - Draft Papers Due


Registration opens January 1, 2019! Early Bird Deadline is March 10. Complete registration information can be found at

Sponsorship Opportunities Available

The mission of the Design of Medical Devices conference is to facilitate collaboration between academia and industry. Exhibit Space is limited. Deadline to sponsor is March 1, 2019. To learn more, contact Jenny Holden, Conference Administrator at

For more information, please visit or contact

Training Programs

Phlebotomy Training in 2 days!

Learn to draw blood quickly. The program consists of one day online training at your own pace and one day hands-on training in the classroom setting. We come to your location. Train now!


October 16, 2018

FDAnews/CenterWatch Webinar

Pharmacy Compounding Regulation: Deconstructing Latest Guidance,
Compliance & Enforcement Activities

1:30 p.m. - 3:00 p.m. EDT

What can you expect from the FDA’s 2018 Compounding Priorities Plan? In this plan the FDA:

  • Addresses quality standards for outsourcing facilities
  • Regulates compounding from bulk drug substances
  • Restricts compounding of drugs that are essentially copies of FDA-approved drugs
  • Solidifies the FDA’s partnership with state regulatory authorities
  • Provides guidance on other activities that compounders undertake

FDAnews has invited Karla Palmer Esq. to bring you up to speed. Ms. Palmer, Director, Hyman Phelps & McNamara P.C., is among the Washington FDA bar’s foremost experts on compounding. She’ll explain the legislation and review in detail the current and future regulatory landscape. You’ll discover:

  • Secs. 503A and 503B: How these sections of the 2013 Drug Quality and Security Act (the “Compounding Quality Act”) affect compounding pharmacies and outsourcing facilities
  • Draft and final guidances: Changes brought about in draft and final guidances to Secs. 503A and 503B
  • Warning letters and 483s: Understand what enforcement actions FDA has taken against compounders to date and what could lie down the road
  • Compounding inspections: What the FDA is looking for right now
  • Role of the states: The interplay between FDA and state regulation of outsourcing facilities and compounding pharmacies
  • And much more

Register today and discover the impact of federal guidance and regulations in this traditionally state-regulated activity.


October 17, 2018

FDAnews/CenterWatch Webinar

Quality Metrics Redux: Taking Advantage of FDA’s Renewed Focus

1:30 p.m. - 3:00 p.m. EDT

The FDA is trying to learn all it can about quality metrics.

The agency began a year-long voluntary site visit program in August to learn what types of metrics drugmakers collect — and which are the best indicators of quality success or failure. It intends to use quality metrics to support its risk-based inspection planning with mandatory participation.

scary prospect? Maybe.

A valuable opportunity? Almost definitely. Mark your calendar for a strategy session with two knowledgeable industry activists, Steven Mendivil of Amgen and Denyse Baker of AstraZeneca. Over the course of fast-paced 90-minutes, they’ll explain the latest developments and what they mean for you. You’ll discover:

  • How the pilot program is progressing and what the FDA has learned so far
  • How to take advantage of opportunities to provide input to the FDA before it drafts regulations to implement the program, including contact with appropriate agency personnel
  • Important details of the FDA’s latest draft guidance on quality metrics, including what information is to be included in a meeting request and what information FDA would like to see during a site visit
  • Major industry concerns, such as metrics selection and definitions, and how the agency is addressing them
  • And much more

Quality metrics is no longer a distant dream. It’s coming — and you need to prepare your quality system to meet it. Register today.

Who Will Benefit Drug and biologics makers distributing Rx or OTC products within the U.S. or holding marketing authorizations with FDA (NDAs, ANDAs, BLAs). Specific job titles include but aren’t limited to:

  • Quality executives
  • Regulatory/compliance
  • Manufacturing/operations


October 18, 2018

An MCC/CenterWatch FREE Webinar

Retooling Risk-Based Quality Management
Approaches in the Era of ICH EG(R2)

11:00 a.m. - 12:00 p.m. EDT

Are the scale… complexity… and costs of your clinical trials increasing?

Since the release of the ICH GCP Guidance updates, your answer is most likely — yes.

And, you — like many sponsors and their partners — might have limited experience with risk-based quality management approaches.

Mark your calendar for Thursday, Oct. 18, when Linda Sullivan, Co-Founder and Executive Director, Metrics Champion Consortium and Keith Dorricott, Director, Dorricott Metrics & Process Improvement Ltd, will discuss approaches sponsors are taking to align with ICH E6(R2). During 60 fast-paced minutes Linda and Keith will:

  • Explore new risk-based quality management requirements described in ICH E6(R2) section 5.0
  • Discuss the importance of critical thinking in risk assessment and risk control
  • Explain the meaning of high and low detectability and the relevance to risk prioritization
  • Describe leading practices to improve risk assessment and quality oversight
  • You have to develop and implement risk-based quality management programs to comply with ICH E6(R2). You owe it to yourself to discover how … and it’s FREE.
  • Sign up now.

Who Will Benefit

This event is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other clinical service providers who have responsibilities in the following areas:

  • Clinical Operations/Management/ Research/Development
  • Clinical Outsourcing/Vendor Management/Third-Party Management
  • Clinical/Project Operations
  • Performance Analytics/Management/Reporting
  • Metric Reporting/Visualization
  • Quality Management/Clinical Quality Management
  • Compliance/Clinical Compliance/ Regulatory Compliance
  • Monitoring/Site Management/Study Management
  • Clinical Risk Assessment
  • Centralized Monitoring / Risk-based Monitoring
  • Good Clinical Practices
  • Clinical Process Optimization
  • Vendor Oversight


October 18, 2018

FDAnews/CenterWatch Webinar

The CDER Reorganization:
What It Means for Drugmakers

1:30 p.m. - 3:00 p.m. EDT

Drug, biologics and combination product makers with new drug approvals (NDA) in the pipeline are bracing for fallout from the planned reorganization of CDER, the Center for Drug Evaluation and Research.

Will the new therapeutic focus help or hurt you? And what action should you take now? FDAnews has answers. Mark your calendar for an all-new FDAnews webinar featuring former FDA investigator and ORA director Ricki A. Chase. Ms. Chase, now a consultant advising big-pharma clients on successful ways to deal with the agency, digs into details of the revamp and suggests how they could affect you. You’ll discover:

  • Why a reorganization? Why now? How the Office of New Drugs is organized now, how it will change, how drugmakers view the changes
  • Day-to-day impact: Specific changes expected to the Office of New Drugs and how they’ll impact what you do every day
  • Is there an upside here? What the FDA says is the goal of restructuring, and opportunities and challenges that could result
  • NDAs: The specific impact on new drug application reviews
  • Drug product quality and compliance: How the restructuring may affect these critical CDER and FDA functions, and others beside
  • And much more

New-drug approval — or denial — can make or break you and your organization. The CDER reorganization is expected to hit NDAs first and worse. Register now.

Who Will Benefit

Drug, biologic and combination product makers with current or pending NDAs. Target attendees include but aren’t limited to:

  • C-Suite
  • Quality executives
  • Regulatory/compliance
  • Manufacturing/operations
  • Design engineers


October 30, 2018

FDAnews/CenterWatch Webinar

Understanding ISO 19011:2018
The Path to Better Medical Device System Audits

1:30 p.m. - 3:00 p.m. EDT

The rules on device quality auditing are changing. There’s a new ISO 19011:2018 out with a new focus on risk management.

FDAnews has called on Dan O’Leary, our go-to guy for quality management, to guide you through the ins and outs. In this 90-minute webinar, he’ll touch on the essentials of ISO 19011:2018 including establishment, implementation, monitoring, evaluation and competence of auditors, and the audit process itself. Prepare to discover:

  • The basics: Learning and applying the seven principles of auditing
  • The updates: How ISO 19011:2018 differs from ISO 19011:2011
  • The six major steps: Understanding the six major steps to conducting an audit
  • … and how they apply: Establishing, implementing, monitoring, review and approval of your audit program
  • Auditor competence: Understanding and evaluating
  • Types of audit sampling: And when to apply them
  • Audit findings: Determining and recording
  • And much more

Bonus Material: Participants receive an audit program checklist, based on the new standard, to help ensure an efficient and effective implementation.

You must adopt best practices and understand the risk-based approach of ISO 19011:2018 for auditing success. Take 90 minutes to master what’s new with the master of device quality management. Register now.

Who Will Benefit

Auditing is a multi-disciplinary activity. Quality auditors may come from a variety of departments and have varied backgrounds. Job functions that would benefit from the presentation include but aren’t limited to:

  • C-Suite execs
  • Quality managers
  • Department managers
  • Process owners
  • Audit managers
  • Lead auditors
  • Internal auditors
  • Supplier quality auditors