About This Course

This highly interactive four-and-a-half-day pharmaceutical microbiology training is designed to provide the aspiring Qualified Person and pharmaceutical quality professionals with the knowledge and understanding they need to assess microbiological risks in the pharmaceutical manufacturing environment. Learn how to assist in the design and implementation of comprehensive microbiological control strategies and how to make informed decisions when microbiological problems occur.

Microbiological contamination of products and processes continues to be a major concern to the industry and its regulators. The potential impact of such contamination can be catastrophic. Put simply, microbial contamination can kill your patients and your business. This pharmaceutical microbiology course is designed to provide both non-biologists and microbiologist with the knowledge, confidence and decision making risk assessment skills to prevent this from happening.

This pharmaceutical microbiology course is approved by the Royal Society of Chemistry as suitable for their members’ continuing professional development.

Key Learning Objectives

On completion of this pharmaceutical microbiology course you will know and understand:

  • The basic characteristics of all microorganisms found in your premises (how they get there and how to remove them)
  • How to sample, isolate and identify these organisms
  • How to prevent contamination of your products and processes using risk management and assessment tools and techniques
  • The interpretation of data
  • QP decision making
  • How to satisfy the regulator and protect your patientK
  • Microorganisms
  • Micro methods
  • Microorganisms and your products, procedures and plants

Course Outline

Microorganisms: Understanding Your “Enemy!”

  • The physiology and key characteristics of microorganisms
  • Routes of contamination

Microbiological Methods: How-to Guidance on:

  • Sampling
  • Isolation and enumeration (counting)
  • Identification (how and when to identify microorganisms)
  • Tests for sterility and preservative efficacy
  • Process analytical technology (PAT)
  • Rapid (non-culturable) methods
  • The microbiology laboratory (Good Laboratory Practice)
  • Monitoring methods

Microorganisms: Your Products, Procedures and Plants

  • Raw materials
  • Contamination control strategies
  • Microbiological aspects of good plant and process design
  • How to use media fills to assess the vulnerability of your process to contamination
  • How to use risk assessment and hazard analysis to identify and remove contamination risks

Microorganisms: How to Remove Them!

  • Good sanitization practices
  • The kinetics of sterilization
  • Sterilization
  • Antibiotics (how they work and how you test them)

Decision Making and Problem Solving

  • How to interpret microbiological data and trends
  • How to identify the root cause of contamination incidents
  • How to use risk assessment techniques to assess the impact of “failures” on product quality and patient safety

Who Should Attend

The Aspiring Qualified Person

  • Our training is generally considered as the best available and our QPs are held in high regard in the industry.
  • As well as being accepted in the UK, our training courses are well known and accepted by several EU countries, including Ireland, the Netherlands, Austria, Hungary and Malta.
  • You are more likely to become a QP with us than with any other training provider.

The Pharmaceutical Technical Professional

  • Not all the people attending these courses intend to become QPs. Many use the training to develop as technical managers in other areas of pharmaceutical manufacture and control.
  • Many industry professionals from a range of disciplines attend the courses as part of their continuing professional development. Taken with some of our other QP modules, this course is designed to lead to postgraduate certificate, diploma and MSc qualifications.

Course Tutors

Course tutors will be selected from the following:

Erika Notman - A microbiologist by training, Erika has over 25 years’ experience in the pharmaceutical industry in both QC and QA, and has worked with all the major dosage forms. She also has expertise in the cosmetics and toiletry industries, and is a previous chair of the CTPA Microbiology Sub-Committee. She is eligible to act as a QP and is an honorary lecturer at the University of Strathclyde.

Tony Mayhall - Tony is a biologist and has held a number of quality and operational roles for a variety of pharmaceutical organizations. His expertise is in auditing and manufacturing liquids and oral solid doses for both specials and commercial pharmaceutical products.

Eric Dewhurst - Eric has spent most of his career working with sterile pharmaceuticals and has held senior positions in microbiology, validation, quality assurance and regulatory compliance with a number of major companies. He provides training on aseptic processing and sterilization and has written textbooks on the subject.

Gavin Halbert - A pharmacy graduate, QP and professor at the University of Strathclyde, Gavin was appointed as Director of the Department of Pharmaceutics’ Formulation Unit in 1992 with a role to formulate and manufacture anti-cancer drugs accepted by CRUK for use in human clinical trials.

Gavin teaches at both the undergraduate and postgraduate level in the areas of pharmaceutics, biopharmaceutics, pharmacokinetics and pharmaceutical microbiology.

He is a co-researcher in the EPSRC Centre for Continuous Manufacturing and Crystallisation and the EU Innovative Medicines Initiative for the Development of Novel Oral Biopharmaceutical Tools (OrBiTo).

Discounts

Early bird and multi-delegate discounts available. Discounts also offered to NHS staff, regulators and charities.

Early bird discounts cannot be used in conjunction with multi-delegate discounts.