Sponsored Webcast: Combination Products: Regulatory Approach and cGMP Requirements

1.0
RAC Credits
Virtual Programs Virtual Programs
Wednesday, 01 December 2021 (12:00 PM) - Wednesday, 01 December 2021 (1:00 PM) Eastern Time (US & Canada)

Combination products represent a noteworthy prospect for the user with regular and long-term dosing requirements. The availability of commercialized devices with automated functions is increasing and this may benefit and reduce the burden on the user and on healthcare systems.


This event is brought to you by Qualio





This webcast will walk you through the regulatory approach and the new regulations applied for combination products. It will also cover the elements of the current Good Manufacturing Practices (cGMP) requirements that are applicable for drug-device single entities and co-packaged combo products.

This webcast will cover:

  • cGMP requirements for the classification of drug-device combination products
  • The common pitfalls drug companies face when they pursue the development of a combination product
  • The best approach for the development of drug and device products
  • Risk management and control strategies
  • The new regulations applied for combination products
  • Labelling requirements

Agenda

TBD

Learning Objectives

Upon conclusion of the program, attendees will understand:

  • cGMP regulatory framework
  • A regulatory approach to the classification of combination products
  • A device QS regulation and drug cGMP based streamlined approach

Pricing Amounts & Deadlines 

Complimentary

Who Should Attend? 

  • Quality professionals
  • Regulatory professionals
  • Compliance managers
  • Risk management professionals

Audience Learning Level

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.


Speaker(s)


Senior Quality Specialist, Qualio

Sumatha Kondabolu has more than 18 years of quality and regulatory experience in the medical device and pharmaceutical industries. She has spent time with start-up, mid-size and multinational companies. Kondabolu has experience in implementing quality management systems—requirements for regulatory purposes US FDA QSR, Canada’s Medical Devices Regulations, NIOSH, and specific requirements of the medical device regulatory authorities participating in the MDSAP program, COFEPRIS, and EU MDR. She holds a master’s in chemistry, and an advanced certificate in quality assurance management, along with auditor certifications for ISO 13485, ISO 17025, and ISO 9001.



Director of Quality, Qualio

Kelly brings over 20 years of experience in both the pharmaceutical and medical device industries to the world of small start-ups and scalable quality system implementations. Having been an implementer, administrator and user of many different eQMS tools on the market, she has built several quality systems and is an advisor to over 30 Medical Device and Pharma companies. She is currently the Director of Quality at Qualio, helping customers and the company adhere to the evolving regulatory landscape.


Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. 

All cancellation requests must be submitted in writing to support@raps.org. RAPS is unable to accept cancellations by phone. 

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee. 


Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance at the following the workshop.


Questions

Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org  

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