Compliance Seminars®

Introduction to Risk Assessment and Risk Management

Overview Risk assessment is currently one of the most frequently discussed topics in the pharma and biopharma industries. Is your firm ready to apply these concepts as you develop new products or improve your processes?

Course description:

This workshop-styled cGMP training course is for pharmaceutical / biotech / biologicals industry personnel who would be involved in applying the concepts and techniques of risk management.
The use of risk assessment and risk management will be examined in regards to process development, operations, and changes. Techniques such as:

  • Hazard Analysis and Critical Control Points (HACCP)
  • Failure Mode Effects Analysis (FMEA)
  • Fault Tree Analysis (FTA)
  • Event Tree Analysis (ETA)

will be discussed and used.

Course goal:

Provide participants a model for a well-written investigation report and enhance their skills at writing and reviewing such reports.


At the completion of this workshop the participant will be able to:

  • Define risk assessment, risk evaluation, and risk management.
  • Discuss the current importance of risk assessment and risk management in the pharmaceutical and biopharma industry.
  • Describe the risk management process, Hazard Analysis and Critical Control Points (HACCP), when it is used, and how it is performed.
  • Describe risk assessment techniques, such as Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), when they are used, and how they are performed.
  • Discuss how risks are evaluated.
  • Discuss how risks are controlled or mitigated.
  • Identify examples of organizational structures and systems that can help or hinder a program of risk assessment and risk management.
  • Given a process or product, identify and apply the appropriate technique.

Who should attend:

Quality, development, operations, and laboratory staff and managers in organizations that must adhere to drug, blood, or biological GMP regulations.

Instructional Methods:

Presentation with visuals, case studies, individual/group activities, small and large group discussions.


When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
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.
Watch this short video to learn more about what Gate2GMP® offers »


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.

Make an enquiry




Course facts

Course no:
Pharmaceuticals and Biopharmaceuticals

GMP region:
US and EU


Date, location and venue:
No planned sessions.

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

1 day
8.30-16.30 (Registration 08.00-08.30)

Price (excl. local VAT):
7 200 DKK (€ 965) incl. course material (pdf), lunch and refreshments
Note. Due to tax/VAT regulations within the EU (for courses/seminars/conferences), the course fee is invoiced in the local currency and local VAT is added.
Accommodation is NOT included in the course fee.

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 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.