Events

Conferences

February 19-20, 2019

Medical Device Risk Management
Atlanta, GA

The gale force flags are flying!

Risk management is just plain hard — complicated, conflicted, confusing. And it’s getting even harder.

The international standard is under revision. While the changes in the process are not intended as “major”, the new standard adds new definitions… changes the clause numbering… introduces new requirements… changes many of the annexes, and moves them to a new document.

In a sister storm, the EU is in transition to new regulations. There are new concepts… new risk reduction requirements… and new applications. Two areas of impact are side-effects (residual risk) and benefit-risk analysis as a life-cycle requirement.

The storm surge affects the many standards that require ISO 14971:2007. Some of them are already in various stages of transition, but all will need an update. Your procedures in these areas require a major refit.

  • ISO 10993-1:2018 on biocompatibility is the new version — it currently requires ISO 14971:2007 but will need an adjustment.
  • IEC 62366-1:2015 on usability has an amendment underway that may include some issues related to the new risk management standard.
  • Other areas that will require adjustment — at the SOP level initially — include software, electrical medical devices, and animal tissues.
  • Your risk management procedures will require a major overhaul.

This workshop — led by industry expert Dan O’Leary — provides the information you need to batten down the hatches and survive the storms. Dan will explain the new version of 14971 and its implementation. He’ll cover the new EU regulation’s risk management requirements through the product life cycle (initial CE Mark and post-market issues). And provide current information on the standards that require risk management and their implementation. During the workshop you’ll:

  • Learn the fundamental concepts of risk management
  • Understand the regulatory structure including the US, Canada, the EU current state, and the EU future state
  • Review recent FDA Warning Letters and understand how to avoid their problems
  • Learn the process flow in the new standard, ISO 14971:xxxx
  • Understand the details of the EU variant, EN ISO 14971:xxxx including the five Z annexes
  • Understand the risk management changes arising from the EU-MDR and EU-IVDR
  • Review the potential relationship between the ISO 14971:xxxx Risk Management System (RMS) and an ISO 13485:2016 Quality Management System (QMS)
  • Review the risk management audit tasks from the MDSAP Audit Model
  • Understand the role of risk management in post-market surveillance
  • Review the entire Workshop agenda.

Your risk management guide is Dan O’Leary, a favorite presenter at dozens of FDAnews-sponsored workshops. Dan provides the understanding and practical tools to join the disparate pieces into a coherent whole and create a solid foundation for the coming changes. Dan boasts more than 30 years’ experience in quality, operations and program management in regulated industries including aviation, defense, medical devices and clinical labs.

Risk management affects nearly every aspect of medical device manufacture. Yet many devicemakers lag behind the curve, courting warning letters or worse. Get your operation up to speed quickly and easily.

For details and registration, Click Here

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.

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

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!

www.phleb.com/privategroups

Webinars

January 17, 2019

FDAnews/CenterWatch Webinar

Recent Developments in ICH Harmonization: Lifecycle Management, Biowaivers & Bioanalytical Method Validation

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

ICH is developing guidelines to improve implementation of post-approval chemistry, manufacturing, and controls (CMC) changes, harmonization of the biopharmaceutics classification system (BCS)-based biowaivers, and bioanalytical method validation.

The ICH Q12 on Lifecycle Management and ICH M9 on Biopharmaceutics Classification System-Based Biowaivers were recently released for public comment. The ICH M10 Bioanalytical Method Validation is currently at Step 1 in the development process.

These guidances promise to streamline global drug development as well as improve pharmaceutical manufacturing and quality assurance.

Keith Webber and Aloka Srinivasan — both of Lachman Consultant Services, Inc. — will discuss the current status and expectations of the ICH guidelines. Over the course of 90-minutes you’ll learn:

  • Why the ICH Q12 guideline is a game-changer for pharmaceutical regulatory and quality professionals
  • What the phrase “Established Conditions” really means
  • How to prepare successful Post-Approval Change Management Protocols to expedite manufacturing process improvements
  • How to use product lifecycle management documents in your submissions and future change management
  • The most problematic components of your submission of product lifecycle management plans
  • The nuances in global harmonization of the BCS classification system for requesting biowaivers under ICH M9
  • What to expect for the global harmonization of bioanalytical method validation under ICH M10

Get ready to streamline your global drug development. Register today.

Who Will Benefit

  • Biopharmaceutical manufacturers
  • New Drug and Generic Drug manufacturers
  • Active Pharmaceutical Ingredient manufacturers
  • Quality professionals
  • Regulatory professionals

REGISTER NOW

January 18, 2019

FDAnews/CenterWatch Webinar

Building a World-Class Drug Supply Chain: Tips for Compliance and Digital Transformation

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

Many manufacturers have acquired the skills and capabilities necessary to “serialize” products, but they are far from efficiently running their manufacturing and supply chain operations.

The ultimate regulatory deadline of 2023 may be five years away, but now is the time for all industry stakeholders — manufacturers, wholesalers, distributors and dispensers — to take a step back and plan for the next five years, while considering the challenges and learnings from the first five years of implementation, keeping the digital future in mind.

2019 is shaping up to be a critical year for industry collaboration and knowledge sharing. Track-and-trace expert Evren Ozkaya — founder and CEO of Supply Chain Wizard, LLC — will discuss laying down a digital supply foundation with track-and-trace capabilities at the center of the systems and processes.

Over the course of 90 minutes he’ll cover:

  • Lessons learned from the first five years of US DSCSA implementations and pilots
  • What the next five year journey will look like for manufacturers, wholesalers and dispensers
  • How to setup the right foundation for digital supply chain & digital transformation
  • Planning for the right ROI initiatives to deliver immediate value vs. strategic value in the long term
  • New technologies (e.g., Blockchain, Internet of Things) that will define supply chain capabilities

It’s time to focus on the challenges and opportunities to minimize regulatory risks and maximize business value the next five years. Register today.

Who Will Benefit

  • Digital Transformation Leaders
  • Chief Executives (CEO, COO, CIO)
  • Operational Executives (Head of Supply Chain, Head of Manufacturing)
  • Serialization Project/Program Managers/Leads
  • Supply Chain/Operations Managers
  • Packaging/Engineering Managers/Leaders
  • QA/QC personnel
  • IT Managers, IT Business Partners

REGISTER NOW

January 29, 2019

FDAnews/CenterWatch Webinar

Developing Pharmaceutical Investigational Brochures & Annual Reports: Secrets to Practical Success and Total Compliance

1:30 p.m. – 3:00 p.m. EST

Are your investigational brochures and annual reports up to snuff?

Whether you’re new to the process or an experienced hand this webinar will provide practical tips and guidance for writing IBs and annual reports that will help you avoid being cited by the FDA.

Tiffany Guckin, associate director of regulatory affairs, Invicro, will discuss the importance of both FDA IND annual reports and investigator brochures and the benefits of timely submissions and reviews as well as the content and structure. Over the course of 90-minutes she’ll help you understand:

  • Essential content to be included in an annual report as outlined in 21CFR312.33
  • The importance of annual reports to the FDA and Sponsors as well as how to develop a world-class annual report compliant with federal regulations
  • Structure and content of an IB per ICH E6 (R2) Good Clinical Practice: Integrated Addendum to ICH E6 (R1)
  • The significance of IBs to research staff and investigators
  • How to ensure that you are accurately representing your investigation to potential subjects
  • Highlight timely submissions and reviews of both annual reports and IBs, including deadlines for filing of documents in order to maintain compliance
  • Best practices that can be included in SOPs or other regulatory processes, including the nuances included in the working instruction documents

This presentation will highlight appropriate content to be included in annual reports and investigational brochures.

Who Will Benefit?

  • Clinical research associates
  • Investigators
  • Clinical project managers
  • Regulatory affairs personnel
  • Medical writers
  • Sponsors

REGISTER NOW

January 30, 2019

FDAnews/CenterWatch Webinar

Regulating Software Used by Life Science Manufacturers: Is it a Medical Device or Not?

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

Life science companies using software in clinical trials, software developers, and producer of artificial intelligence products need to know what software is a medical device and what’s not.

Life science companies utilizing AI or buying off-the-shelf software products often don’t realize that they’re using those products as medical devices and that significant fact impacts the ability to get their device approved and the validity of the data they’ve collected and compiled.

Many life sciences manufacturers simply don’t realize their product will be considered a medical device and don’t know what regulations apply. James Rogers, founder and head of Compass Life Science Solutions, has more than 20 years experience dealing with compliance requirements. Over the course of 90-minutes he’ll help you understand:

  • The process by which to classify an SaMD based on U.S. and international guidance
  • How a company’s use of a software product impacts the classification of SaMD
  • When a purchased software product becomes an SaMD
  • Remediation approaches to resolve SaMD compliance issues
  • Best practices on development and validation strategies for SaMD

This presentation will help you assess your software products and implement software development and validation best practices. Register today.

Who Will Benefit

  • Owners of SaMD companies
  • Quality individuals responsible to the use of software in clinical trials
  • Quality individuals responsible for the validation of device software.

REGISTER NOW