Events

Conferences

March 26-27, 2019

Conducting Advanced Root Cause Analysis and CAPA Investigations
Raleigh, NC

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 — March 26-27, 2019 in Raleigh, NC — 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 — Register Today

But that’s not all. Additional benefits you'll receive when you attend the Conducting Advanced Root Cause Analysis and CAPA Investigations include:

  • Gain valuable strategies for getting information right away in the “golden hours” after the incident.
  • Discover best practices for determining the real cause of human error with tools used by aviation accident investigators.
  • Benchmark current best practices in CAPA and investigations with your peers.
  • Learn practical strategies and techniques you can teach to all your employees.
  • Obtain sample forms for conducting investigations and case reviews.
  • Demonstrate to yourself the value of a cross-functional team and also ways that experts demonstrate their expertise.
  • Understand the four components of a well-written report and Identify better ways of finding the real reasons behind the category of “human error” — and ways to better control and mitigate those factors.
Register today and enhance your skills to more effectively identify what caused an unwanted event and ways to prevent future ones.

March 27-28, 2019

ICH GCP E6 R2 Meeting CRO-Vendor Oversight Requirements
Raleigh, NC

What CRO and vendor activities require oversight?

How can you avoid the common pitfalls of effective implementation of CMO-vendor oversight?

How are your fellow CROs handling these and other issues?

Join them and nationally recognized expert Liz Wool, CCRA, CID, CMT for face-to-face discussions on how to handle ICH GCP E6 R2 compliant CRO-vendor oversight.

Liz will provide methods and solutions for effective implementation of the ICH GCP E6 R2 rules. Over the course of the two-day hands-on workshop she’ll:

  • Explain the regulatory authority perspective for CRO and vendors in relation to ICH GCP E6 R2 requirements
  • Identify the CRO-vendors requiring oversight
  • Determine the CRO-vendor practices for oversight of their sub-contractors to meet the requirements and your organization’s expectations
  • Examine effective and compliant CRO-vendor oversight methods
  • Assess CRO-vendor governance-leading practices to implement at your organization
  • Formulate a CRO-vendor oversight plan template for your organization that can be used by multiple departments
  • Examine the common pitfalls to effective implementation and leading practices to mitigate the risks of these pitfalls from occurring in your organization
  • Describe regulatory authority inspection findings regarding CRO-vendor oversight

Through presentations, discussion, class activities and handouts you’ll learn how to implement ICH GCP E6 R2 requirements in your organization. Join us for two days of networking and face-to-face interaction with a nationally recognized CRO-vendor expert.

For details and registration, Click Here

April 8-12, 2019

FDA Compliance Boot Camp 2019
Frederick, MD

Imagine getting inside the head of a working FDA inspector ...
receiving the same training the inspector gets ...
knowing which problems face the most scrutiny ...
all before your next inspection.

Here's how.

Are you confident you'll sail through your next inspection? You can be when you have the same training the FDA gives its own inspectors.

Know what to expect when the next inspector walks through your door -- from what the agency trains its investigators to look for ... to which problems face the most scrutiny, including how FDA expects you to manage your computerized systems and electronic records.

You'll even discover which of your systems will be first-up for inspection. And you'll learn what's behind FDA's new add-on "surveillance inspections" for Part 11 and how the European Union's new Annex 11 affects your operations, no matter where they are.

Former FDA Investigators Ready to Give You "Insider Advice"

Why risk a single noncompliance penalty? When you attend FDA Compliance Boot Camp 2019 you can feel secure in knowing your next inspection will be a complete success ... And it takes less than a week.

Experience a simulated inspection, pick up effective self-auditing techniques and so much more.

Save $695 Now: When You Choose a Multiple Course Track

Choose any one course or a combination of courses to suit your needs and fit your schedule.

Learn more.

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

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

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 rampi002@umn.edu.

For more information, please visit www.dmd.umn.edu or contact dmdconf@umn.edu

April 23-25, 2019

Medical Device Quality Congress
Bethesda, MD

Save the date!

Testimonials From Past Attendees:

“I love coming away having learned something new that I didn’t realize I was missing.”

“I liked the breadth of information presented and the knowledge of the speaker. I also liked the informal atmosphere that allows for questions during the day and not just during specific.”

“Great information and excellent speakers.”

Click here to get updates and the complete agenda as soon as it’s available.

October 23-25, 2019

FDA Inspections Summit
Bethesda, MD

Save the date!

Testimonials From Past Attendees:

“Great discussion and knowledgeable panel. I enjoyed having the FDA give examples in their own words…”

“The panels were great. Very informative and great discussions.”

“Great and interesting sessions. Great panel discussions and attendee participation.”

“I certify this Summit a success.”

Click here to get updates and the complete agenda as soon as it’s available.

Training Programs

There are more training programs to come. Please check back soon.

If you would like to post a training program yourself, please contact us at sales@centerwatch.com or call (866) 219-3440 to speak with a representative.

Webinars

REGISTER NOW

February 19, 2019

FDAnews/CenterWatch Webinar

Outsourcing Facility Compounding: New Guidance for Outsourcing Facilities

1:30 p.m. – 3:00 p.m. EST

In December 2018 the FDA released a new draft guidance addressing the standards outsourcing facilities must follow in their compounding activities.

How will these new requirements affect you?

Lee H. Rosebush — partner at Baker Hostetler and chairman of the Outsourcing Facilities Association — will address the newly proposed standards and will discuss several outstanding questions the industry must confront. After 90-minutes of discussion you’ll understand how to:

  • Comply with the nuances of the revised guidance — including the new line drawn between sterile and non-sterile drug products
  • Implement best practices to protect against contamination
  • Comply with the guidance while making it feasible for outsourcing facilities to fulfill requests for office stock and maintain product quality
  • Ensure that a compounder’s quality control conducts sterility assurance activities for sterile products and microbiological quality activities for non-sterile products
  • Conduct annual quality standard evaluations of drug products
  • Comply with FDA evaluation requirements
  • Comply with revisions on release testing, reserve samples, the definition of “in-use time”, the use of third party laboratories for testing purposes and stability testing
  • Understand issues left unresolved by the guidance

This presentation will help you understand the new requirements presented by the revised guidance and how to comply with them

Who Will Benefit?

  • Executive suite
  • Strategic planners
  • Regulatory affairs
  • Quality affairs
  • Manufacturing executives
  • Legal counsel

REGISTER NOW

February 20, 2019

FDAnews/CenterWatch Webinar

FDA’s Plan for Modernizing the 510(k) Pathway: What Regulatory, Quality & Compliance Professionals Need to Know

1:30 p.m. – 3:00 p.m. EST

As medical device software and other technology continue to advance at a rapid pace, the FDA’s regulatory policies and processes are being forced to evolve to keep pace with innovation.

Instead of basing substantial equivalence on older predicate devices, the FDA is looking for equivalence to a contemporary baseline of objective safety and performance criteria.

Mary Vater, medical device consultant at Medical Device Academy, Inc., will share best practices and tips for preparing and submitting 510(k)s. She’ll discuss common mistakes and the FDA’s current and evolving expectations for submissions. After 90-minutes you’ll know:

  • What specific changes the FDA has made to the 510(k) process — including the implications for companies who choose predicates cleared more than a decade ago
  • How to identify a suitable and favorable predicate device
  • What type of adverse events are common in your product classification
  • How to deal effectively with new challenges — including the possible need for additional testing to reflect post-market information for your device classification
  • How the FDA is addressing the changing biocompatibility requirements
  • How to overcome specific challenges companies face in creating and executing a sufficient test plan
  • The best time to file your pre-submission within the development process
  • The right questions to ask to gain the most value from your meeting

This presentation will break down the 510(k) process and let you know what changes you can anticipate for future submissions.

Who Will Benefit?

  • Regulatory affairs specialists
  • Medical device consultants
  • Biomedical engineers
  • Research and development engineers

REGISTER NOW

February 27, 2019

FDAnews/CenterWatch Webinar

FDA Medical Device Compliance and Enforcement: Lessons from Last Year and Your Game Plan for This Year

1:30 p.m. – 3:00 p.m. EST

What do CMMI and MDSAP mean for the software pre-certification program and de novo regulation?

Bethany J. Hills, Chair, FDA Practice and Aaron Josephson, Senior Director — both of Mintz Levin — will provide a comprehensive understanding of compliance and enforcement trends and the contextual relationship of policy and regulation. You’ll learn about:

  • What areas the FDA targeted in inspections in 2018 and has focused on for enforcement in 2019
  • The nuances in compliance areas that create risk and should be closely monitored in your quality system
  • The differences and revisions in inspectional programs affecting all medical device regulatory and quality professionals
  • Enforcement tools the FDA will be using in 2019 to ensure compliance and evolving trends in how the FDA seeks enforcement
  • The business implications of FDA enforcement trends and compliance policy through its new initiatives

Join us on Feb. 27 and keep up to date with the latest thinking on FDA medical device compliance and enforcement.

Who Will Benefit?

  • Quality and regulatory professionals
  • Operational and management
  • Executive and strategic
  • Legal and compliance

REGISTER NOW