"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"

Compliance Seminars®

Combination product - Insulin pen

US Combination products requirements for
the Pharmaceutical & Biotech Industry

With the new final FDA Guidance
"CGMP Requirements for Combination Products"
issued January 2017

Understanding the additional requirements from 21 CFR 820 when applying the streamlined approach


Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. Because combination products involve constituent parts  that would normally be regulated under different types of regulations, and usually by different FDA Centers. This course will specifically focus on the compliance challenges for a manufacturer of a medicinal product (drug product) that also is combined with a medical device, either as a single entity combination product or as a co-packed combination product.

Course description:

This course will discuss the scope of CGMP requirements for combination products (21 CFR 4) out of a pharmaceutical and biopharmaceutical based quality systems point of view. It will cover compliance requirements related to the medical device constituent part  in US. The first part of the course will walk through the overall topics related to combination products and compare the different regulations, look into similarities and differences. The later part will focus entirely on the quality system requirements normally not required according to medicinal (drug) product regulations.

Course outline:

  • Overview of Combination products regulations in the USA & Europe
  • Introduction to 21 CFR 4
  • Management Controls
  • Design Controls
  • Purchasing controls
  • CAPA
  • Differences in Process Validation approach

Who should attend:

This course is for any professional involved in the development, manufacturing, control or QA of a Combination product within the pharmaceutical and biopharmaceutical industry. It will also be useful for individuals that have oversight for or actively participate in drug delivery combination product development teams. It will certainly be of interest for any professional who needs additional knowledge to be able to audit against 21 CFR 820 requirements in addition to drug CGMPs.


The objective of this 2 day session is to understand the additional requirements from 21 CFR 820 that needs to be taken into consideration for a pharmaceutical CGMP based quality system. This course will provide the audience the ability to create a GAP analysis of the company situation and position in terms of compliance with the combination product requirements. After the course the attendees will be able to explain the GMP/QS expectations and responsibilities relevant to companies developing and manufacturing a combination product.


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At Gate2GMP® each course has its own page where you can download course materials, receive up to date information and communicate in the course forum.
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Bring this course in-house?

Are you a group in need of the same training?
Do you wish to customize this course to suit your needs?

 If so, running the course in-house is probably the best and most cost effective solution.

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Course facts

Course no:
Pharmaceuticals and Biopharmaceuticals

GMP region:
EU and US


Date, location and venue:

This course is also offered in-house.
Click here for more info and inquiry form.

2 days
8.30-16.30 (Registration 08.00-08.30, day 1)

Price :
1 925 Euro incl. course material (pdf), lunches and refreshments.

Accommodation is NOT included in the course fee.
Note. 25% VAT (deductible) is added for Swedish customers.

For groups registered and invoiced together we offer the following quantity discount:
2-3 persons 10%
4 or more 20%
We do not offer or practice any general company discounts without commitments and/or written agreements.

Course material (Handouts)  
No printed course material will be provided on our courses*.
This is primarily to protect the environment. Therefore, we encourage you to bring a laptop / tablet to the course - it is possible to make notes in the PDF file you will have access to.
1-2 weeks prior the course you will receive login details to www.Gate2GMP.com where you can download the course handouts as a PDF.
Note pads and pens will always be provided at the venue.

Cancellation policy - Compliance Seminars®  

Cancellation of registration:

Registration is binding and when you have received our confirmation the following conditions are known and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.
All cancellations and/or substitutions must have been communicated with and confirmed by us.
Cancellations received less than 30 calendar days before course start are subjected to a service charge of 150 € (Euro)/registered course day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 7 calendar days prior the course, or failure to cancel or "no-show", will be charged in full.

Cancellation of courses: Courses may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the course start), or due to other reasons beyond our control. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled course. If you need to book flights way ahead (+35 days prior the course) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.