System Suitability Tests (SST) and Troubleshooting for HPLC Methods - Live Online Training

Tuesday, 4 November 2025 9 .00 - 17.00 h

Course No. 22319

header-image

Speakers

Dr Heiko Brunner

Dr Heiko Brunner

Hamburg

Dr Gerd Jilge

Dr Gerd Jilge

Formerly Boehringer Ingelheim

All times mentioned are CET.

Objectives

This Live Online Training provides a comprehensive insight into the requirements of SST criteria, including their acceptance limits. The event combines theoretical concepts and case studies with practical exercises to equip participants with a thorough understanding of HPLC method evaluation and troubleshooting.

Background

The SST is an essential part of any GMP analysis, particularly when applying chromatographic methods. It ensures the proper functioning of both the analytical system and the corresponding analytical procedure, including sample preparation.
Before establishing new HPLC methods in one's own laboratory, a thorough review and evaluation are necessary. Potential sources for new methods include external laboratories (as part of method transfer), literature descriptions, pharmacopoeial monographs, or inhouse developments. A detailed analysis of potential weaknesses can help prevent later issues, including variation applications in regulatory approvals. If difficulties arise when applying a new method, troubleshooting can often be time-consuming and costly.

Target Group

This Live Online Training is designed for participants who wish to expand their knowledge of SST and troubleshooting of HPLC methods. It is particularly aimed at: ƒ
  • Heads of Quality Control
  • Qualified Persons (QP)
  • Laboratory Managers
  • and all laboratory staff in pharmaceutical quality control and analytical development.
It is also relevant for professionals from control departments of active pharmaceutical ingredient (API) and excipient manufacturers, as well as contract laboratories. Furthermore, this Live Online Training is of interest to employees and managers in quality assurance.

Date & Technical Requirements

Date
Tuesday, 04 November 2025
09.00 – 17.00 h CET

Technical Requirements
We use WebEx for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

System Suitability Tests (SST) and Troubleshooting for HPLC Methods - Live Online Training

Seminar Programme as PDF

System Suitability Test (SST)
  • Importance of SST – Why is the system suitability test so important?
  • Regulatory requirements
  • Current changes in the pharmacopoeial SST chapters
  • SST parameters and their acceptance criteria
  • How to obtain the optimal SST (development of SST)?
  • Dos and Don'ts of SST
  • How can SST contribute to the "Analytical Life Cycle"?
  • Why is SST not sufficient for the qualification of analytical systems?
  • Examples of System Suitability Tests for other chromatographic and non-chromatographic analytical Methods
  • Is an SOP required for SST?
Evaluation and Troubleshooting of HPLC Methods
  • Common issues and their causes
  • Evaluation criteria for HPLC Methods
  • Choosing the right method Parameters
  • Diagnostic tools, checklists, and performance Monitoring
  • Assessment of chromatograms
  • Approaches to error correction and solution strategies
Interactive Learning Components
  • Quiz – deepening Knowledge
  • Case studies – practical examples on troubleshooting
  • Interactive workshop – group work: troubleshooting an HPLC method

ECA-Member*: € 1090,-
Regular Fee*: € 1290,-
EU/GMP Inspectorates*: € 645,-
APIC Member Discount*: € 1190,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

icon
Further dates on-site
Further dates on-site
Not available
icon
Further dates online
Further dates online
Not available
icon
Recording
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

Woman with headset

Go back

Testimonials about our courses and conferences

"Great material and speakers" and "Great speakers a lot of experience and sharing"

Felipe Gonzalez, Mucos Emulsionsgesellschaft mbH
Live Online Training - Granulation & Tableting, September 2024

"The lectures were very informative, interesting and entertaining."

Albert Godoy Hernández, Company synaffix
Live Online Training - GMP Auditor Practice, October 2024

"Really useful training which I will use in my daily work."

Regina Mommaerts, Galapagos NV
Live Online Training - GMP Auditor Practice, October 2024

"Wonderful format of the sessions: Good range of participations and experience in the team. Would love to attend another one soon."

Roopasi Mathi, Wacker Biotech B.V.
Live Online Training - GMP Auditor Practice, October 2024

"Very good balance between general and detailed information"

Dr Ralf Albrecht, Tillotts Pharma AG
Live Online Training - Granulation & Tableting
September 2024

"Nice presentations: easy understanding, quite visual"

Susana Manrique, Boehringer Ingelheim España, S.A,
Live Online Training - Granulation & Tableting, September 2024

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Both, organizers and lecturers were very friendly, open for discussions and extremely constructive. The course was a valuable experience for me.”

Maria Dimitrova, NKN Law Firm
Pharmaceutical Contracts: GMP and Legal Compliance, March 2025