Course Description:

The course will give the participant the ability to formulate an QMS document and a thorough understanding of verification and validation procedures, The course will also give through guidance in development of Combination products both for the USA and European marketplace from a regulatory and manufacturing point of view. Emphasis will be placed on critical pathways, clinical development and regulatory approval.

Learning Objectives:

Upon completing this course participants should understand:

  • Office of Combination Products Update
  • The new draft guidance on CGMP requirements for combination products
  • Other recent and upcoming guidances and issues
  • The combination product development process
  • Clinical evidence development and coordination for combination products
  • Companion diagnostics regulations, guidances, and challenges
  • FDA assessment of combination product submissions
  • Industry assessment of FDA review of combination products
  • Aligning pharmaceutical CGMP and device Quality System Regulations
  • Quality by Design vs. Design Control
  • Risk management and combination products
  • Human factors and combination products – paradigm matching
  • Reconciling drug and device postmarket requirements and processes
  • Combination product inspections
  • Combination products in a global marketplace.

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Who Will Benefit:

  • Drug, device, diagnostics, and biologics regulatory, quality, and clinical professionals involved with combination product development and oversight
  • Product stewards
  • Business development executives involved in combination product strategic partnerships
  • R&D and product testing professionals
  • Combination product supply chain professionals

Course Outline:

Day 1 (8:30 AM – 4:30 PM) Day 2 (8:30 AM – 4:30 PM)
  • 8:30 – 9:00 AM: Registration
  • 9:00 AM: Session Start Time
  • Combination Product Regulatory
    • Product profile, data, and performance
    • Metrics: mean approval times by product types or regulatory pathway
    • Recent and upcoming guidance documents
    • Are companies going to OCP for help with designations?
    • Making best use of OCP during the combination product life cycle
    • Jurisdiction of kits and other ambiguous products
    • Office of Planning report on FDA handling of combination products
  • The Combination Product Development Process
    • Evaluation of process improvement
    • IT assessment
    • Evaluation of industry performance
    • Key issues and deficiency
  • Quality by Design vs. Design Control
    • Compare and contrast the objectives and approaches
    • What is part of design validation?
    • Will CDRH and CDER accept the other’s approach?
    • Aligning the processes
  • Pharmaceutical CGMP and the Medical Device QSR
    • The GMP guidance document
    • Pharmaceutical CGMP
    • Purchasing controls in drugs vs. devices
    • The problem of retains and lot sizes
    • Panel discussion – How did you modify your quality system to accommodate combination products?
    • Pharmaceutical companies
    • Medical device companies
    • Managing internal documentation at each facility
    • Case studies
  • Developing Clinical Evidence
    • Different drug and device clinical evidence requirements
    • Differing knowledge of mechanisms of action
    • Challenges of conducting device clinical studies
    • When is clinical evidence necessary, and what information should be collected (e.g. in bridging studies)
    • How do cGMPs / QSR apply during clinical studies?
    • Factors best addressed in simulated real use environment vs. controlled environment
    • Good Clinical Practices
  • Human Factors and Combination Products
    • FDA human factors guidance – status or report
    • Cultural differences – medication errors vs. engineering approaches
    • Case study – FDA review approach: roles and responsibilities of CDER vs. CDRH reviewers
    • Should non-significant risk human factor studies be submitted in the IND?
    • Value of or need for non-observational (real world use) usability testing
  • Risk Management and Combination Products
    • Reconciling drug and device approaches
    • The risk of the whole vs. the risk of the parts
  • Companion Diagnostics Regulations and Process
    • What is a companion diagnostic?
    • What are the challenges with companion diagnostics?
    • How do the proposed changes to FDA’s stance on LDT regulation affect companion diagnostics?
  • The Global Landscape of Combination Products
    • Definitions and Regulatory Pathways
    • Challenges

Meet Your Instructor

Virginia A. Lang, PhD
President & Chief Scientist, HirLan, Inc.

Virginia started in the medical research field as a Coordinator of Research at the Clinical Research Unit Kennedy Institute of Johns Hopkins Medical Center. She was responsible for the initiation, coordination, and management and/or analysis of research projects in the Clinical Research Unit. These projects were funded by various Federal Government Agencies. Subsequent to Johns Hopkins Medical Center, Virginia entered the field of Human Factors through the doctoral program at SUNY Binghamton. Virginia held a fellowship at the Aeromedical Research Laboratory of the United States Air Force at Wright-Patterson AFB, Dayton, Ohio and a fellowship at NASA. Her research dealt with cognitive factors that differentially affect the characteristics of visual displays. Applications of this research are directly related to various medical devices and software applications providing Medical Device Human Factors by HirLan clients with 30 years of Human Factors experience.

In addition, Virginia has extensive experience in the areas of product design, Customer Centered Participatory Design processes, and product lifecycle management. She is also known in the Human Computer Interaction and Usability Communities for her innovative techniques for collecting and incorporating user/customer feedback throughout the product lifecycle. In July 2014, Virginia founded and established the HirLan Institute of Human Factors with labs in Carlsbad, California and a Consortium arrangement in London, UK. In February 2013, Virginia founded HirLan International SA, a Geneva, Switzerland based company. Both HirLan and HirLan International have been supporting Top Ten pharma/medical device companies, as well as, start-ups with consulting and testing services. These services are in conjunction with their clients’ FDA 510(k) and CE mark applications.

Virginia holds a PhD in Cognitive-Experimental Psychology from SUNY Binghamton, and a Master of Science (ABT) in Applied Technology, Systems Science from SUNY Binghamton.

Register Now

Online using Credit card

Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at [email protected]

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]

Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Media Partners


Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.

Media Partner To Do
  • Banner (min 728x90 or 468x60) on the media partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the magazine and/or website.
  • Dedicated email blast to media partner’s subscribers.
  • Article on the magazine and/or website after the conference.

Local Attractions

This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.

The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).

Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.

Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.

The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.

This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.

The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Paul Revere that the British were approaching by boat, not on foot.

We need below information to serve you better



6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube


Copyright © 2023 MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method