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Aseptic Processing & Contamination Control (Annex 1)
Tailored In-House Training

Aseptic Processing & Contamination Control (Annex 1)

Updated Friday, 5 June 2026 at 13:07

A practical three-day seminar that bridges basic training and specialist courses, giving team leads the depth to make confident quality decisions in aseptic production.

Custom On-Site Training

This training is delivered at your location and tailored to your organisation's specific needs, processes, and compliance requirements.

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What's included

  • Programme tailored to your organisation
  • Delivered at your location
  • Flexible scheduling
  • Training certificate for participants
  • Experienced trainers from industry and regulatory

Difficulty

Beginner level Intermediate level

Topics

GMP EudraLex Volume IV Quality Assurance QC Qualification Quality Culture Sampling Manufacturing CCS Sterile Aseptic OOS Qualified Person Data Integrity ALCOA Impact Assessment Rootcause Analysis Risk Assessment Incoming Goods Awareness Quality Awareness ICH Q9 Microorganisms Env. Monitoring (EM) Gowning Sterilization Personnel PIC/S Risk Management Cleaning Validation Utilities Desinfection Cleaning Sterility Assurance Premises U.S. FDA Microbiology Cleanroom Air Handling Isolator RABS VHP WFI Gowning Depyrogenation APS Media Fill

Categories

Good Manufacturing Practice (GMP) | GMP Training Sterile Manufacturing

What you will learn

Understand the quality aspects of aseptic production and the rationale behind a Contamination Control Strategy

Navigate the legislative framework for aseptic production, with emphasis on EU GMP Annex 1, U.S. FDA regulation and PIC/S

Map every step of the aseptic production process and the control measures associated with each

Recognise microbial contamination sources and critical points of attention

Explain the role of premises, equipment, utilities and personnel in maintaining sterility assurance

Interpret Environmental Monitoring, media fills (APS) and Quality Control in relation to Annex 1

Apply practical approaches to handling deviations and quality issues

Make well-considered quality decisions as a team lead — including when processes do not run entirely as planned

Description

Within aseptic production, microbial control is critical. The revised EU GMP Annex 1 sets high expectations for knowledge, risk management and decision-making at the operational level. This three-day seminar gives team leads and related roles the depth they need to fulfil their part in the aseptic process with confidence and insight.

The course forms an essential link between basic/on-the-job training and specialised programmes such as microbiology or aseptic process design. Over three days it builds an integral picture of the full aseptic process and the way individual control measures fit together — so participants understand not just what is required, but why.

The programme combines theory with hands-on workshops, including root-cause analysis (Ishikawa/fishbone and 5x Why), hand-hygiene and gowning exercises using UV powder, cleaning and disinfection practicals, and team-lead case studies. Participants apply what they learn directly through real-world scenarios and an action plan that translates theory into their own practice.

  • Legislation and regulation: EU GMP Annex 1, U.S. FDA and PIC/S (US FDA is optional, training can also be focused solely on EU (or WHO))
  • Microbiological and Contamination Control Strategy (CCS) and the Pharmaceutical Quality System (PQS)
  • Microbiology in practice and sources of contamination
  • Premises: cleanrooms, HVAC, isolators and RABS
  • Cleanroom qualification, cleaning, disinfection and VHP
  • Equipment, utilities and water systems (WFI)
  • Personnel behaviour, gowning and responsibilities in the cleanroom
  • Aseptic processing, Environmental Monitoring, APS/media fills and Quality Control
  • Decision-making at team-lead level: what to do when things don't go entirely to plan

Target Audience

This training is designed primarily for team leads in aseptic production who already have a working knowledge of processes and quality management, as well as colleagues familiar with contamination sources and GMP legislation. It is also valuable for professionals closely involved in quality management within sterile manufacturing, and for staff working in a single department or task area who want an integral overview of the whole aseptic process and how their role connects to it. It is not an introductory course, but a deepening layer between foundational on-the-job training and specialist programmes.

Contents

Three days covering: legislation and regulation (EU GMP Annex 1, FDA, PIC/S), the (M)CCS and PQS, microbiology in practice, premises (cleanrooms, HVAC, isolators, RABS), cleanroom qualification, cleaning and disinfection, VHP, equipment and utilities, personnel behaviour and gowning, aseptic processing, Environmental Monitoring, media fills (APS), Quality Control, and team-lead decision-making. (US FDA is optional, training can also be focused solely on EU (or WHO))

Programme

Results

After this training you will have a complete picture of the key aspects of contamination prevention in the aseptic production process; understand the connections between processes, control measures and responsibilities; have in-depth insight into contamination sources and risk areas; know the relevant legislative framework (EU GMP Annex 1 and U.S. FDA); understand which measures safeguard microbial quality; and understand your own role and responsibility within the overall quality system. For the organisation this strengthens inspection readiness, risk-aware decision-making, consistency of decisions, and assurance of microbial quality. (US FDA is optional, training can also be focused solely on EU (or WHO))

Request an offer

Interested in this training for your organisation? Fill out the form below and we will prepare a tailored offer for you.