LIVE ONLINE COURSE · TAUGHT IN ITALIAN
GMP Microbiology
Laboratory Management
Practical guidance for managing microbiological testing, method validation, investigations and data integrity in a GMP environment.
This four-hour course examines the day-to-day responsibilities of a pharmaceutical microbiology laboratory and the decisions behind them: what must be tested, how methods should be validated, how unexpected results should be investigated and how laboratory data should be managed.
Thursday, December 3rd, 2026
09:00–13:00 CET · Online · Italian
Trainer: Eleonora Piccini
Why this course matters
Performing a microbiological test is only one part of the laboratory’s responsibility.
The method must be suitable for its intended use. Unexpected results must be investigated properly. Decisions must be scientifically justified, clearly documented and supported by reliable data.
This course looks at how those responsibilities are managed within the pharmaceutical quality system, with a practical focus on method validation, microbiological deviations, OOS/OOT investigations and Data Integrity.
What you will learn
By the end of the course, you will be able to:
Interpret the main regulatory requirements applicable to microbiology laboratories, including Annex 1 and Annex 15.
Identify the microbiological testing requirements for raw materials, intermediates and finished products.
Structure validation protocols for microbiological methods, including sterility and bioburden testing.
Approach microbiological deviations and OOS/OOT results through a structured investigation.
Assess whether an unexpected result may be linked to laboratory error or genuine batch contamination.
Apply Data Integrity principles to the recording, review and management of microbiological data.
Course programme
Module 1
The Microbiology Laboratory in the Quality System
The role and responsibilities of a microbiology laboratory in a GMP environment.
Environmental classification
Culture media and reference strains
Equipment qualification and laboratory controls
Module 2
Microbiological Testing
Testing requirements for raw materials, intermediates and finished products.
Testing by material and product category
Sampling and testing considerations
Impact of testing decisions on product quality
Module 3
Microbiological Method Validation
How to structure and justify the validation of microbiological methods.
Validation protocol design
Sterility and bioburden testing
Accuracy, precision and robustness
Module 4
Deviations and OOS/OOT Investigations
How to investigate unexpected microbiological results and define the appropriate response.
Phase I and Phase II investigations
Laboratory error and batch contamination
Root cause analysis and CAPA
Who should attend
This course is intended for professionals who perform, supervise or make decisions involving microbiological laboratory activities in GMP environments.
It is particularly relevant for:
Microbiology laboratory analysts.
Laboratory supervisors and managers.
Quality Assurance professionals involved in investigations, audits or batch release.
Production professionals whose sampling decisions may affect microbiological control.
GMP consultants working with laboratory or quality systems.
Professionals moving into pharmaceutical microbiological quality control.
The course will be especially useful to anyone who needs to review validation protocols, participate in OOS/OOT investigations, prepare laboratory documentation for audits or inspections, or strengthen Data Integrity practices.
What is included
Your registration includes:
A four-hour live online course taught in Italian.
The course presentations, sent after the session.
A signed certificate of participation issued by Biotech Academy in Rome.
About the trainer
Eleonora Piccini
Senior Quality and Regulatory Professional · EU Qualified Person
Eleonora Piccini has more than 23 years of experience across the pharmaceutical, biotechnology, medical device and food sectors.
Her work covers GMP and GxP compliance, quality management systems, regulatory strategy, technology transfer, and sterile and non-sterile production processes. She has also worked directly with regulatory authorities including AIFA, EMA, MHRA and ANVISA.
Frequently asked questions
The course will be delivered in Italian. The language of the session is indicated before registration so that participants can confirm that it is suitable for them.
Yes. The session will take place online on Thursday, September 3rd 2026, from 09:00 to 13:00 CET.
The course lasts four hours.
The €350 fee includes VAT, the live online session, the course presentations and a signed certificate of participation issued by Biotech Academy in Rome.
Yes. The course presentations will be sent to participants after the session.
Yes. A signed certificate of participation issued by Biotech Academy in Rome is included in the registration fee.
Once your payment has been confirmed, you will receive a confirmation email at the address provided during registration. The email will contain the information you need to join the online session.
You may cancel your registration for a full refund up to 48 hours before the course starts. Cancellations made after that deadline are non-refundable.
Yes. To request an invoice, send your billing details to info@biotechacademy.eu.
Strengthen your GMP microbiology practice
Join this live online course to examine the practical decisions behind microbiological testing, method validation, deviations, OOS/OOT investigations and Data Integrity.
Registered Office
Nexantia Biotherapeutics S.r.l.
Viale di Trastevere 141, 00153 Rome Italy
P.IVA: IT17204271005
SDI: 5RUO82D
