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Pharmaceutical Microbiology Training

Dates

Times

5 days20 hrs VILT, 5.5 hrs self-paced

Location

Virtual Learning

Availability

About This Course

This highly interactive, pharmaceutical microbiology course is designed to provide the aspiring Qualified Person and pharmaceutical 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.

Our virtual instructor-led training will be delivered via a combination of live instructor-led virtual classrooms and self-paced online learning. Full details will be sent following registration.

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)
  • Microbiological methods
  • 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 patient

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
  • Rapid (non-culturable) methods
  • Monitoring methods

Microorganisms: Your Products, Procedures and Plants

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

Microorganisms: How to Remove Them!

  • Good disinfection practices
  • Sterilisation and filtration

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
  • Taken with some of our other QP modules, this course is designed to lead to postgraduate certificate, diploma and MSc qualifications

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

Course Tutors

Alan Whipple – Alan is a pharmaceutical microbiologist with more than 35 years of operational experience. He has managed site microbiology units supporting the manufacture of sterile and non-sterile products. His expertise is in sterile manufacture and microbiology of API and non-sterile products.

Ian Harwood – Ian is a GMP Consultant with over 20 years’ industry experience, including extensive knowledge of Pharmaceutical Quality Systems and GMP for steriles, biotech, IMPs, radiopharmaceuticals and unlicenced medicines. He spent 8 years as a GMP Inspector with the MHRA and is eligible to act as a Qualified Person.

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.

Joanne Spiers - Joanne has nearly 30 years of experience in the pharmaceutical industry providing diverse experience in all areas of quality assurance (QA) across multiple dosage delivery platforms.

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

Multi-delegate discounts available. Discounts also offered to NHS staff and charities.

Qualified Person Training With NSF

Watch the video
  • The course gave me an excellent view about the microbiological hazards in the pharma industry. Once you know the hazards you can fight them.
    Rafael Ramos Curto
    MSD Animal Health, Spain
  • Interactive, excellent buzz groups to help link learnings of course to real life. Excellent delivery of each session by all tutors.
    Pauline Chan
    Merck Sharp and Dohme, UK
  • Really useful amount of information, with good focus on practical aspects and application.
    Fiona MacDougall
    Fiona MacDougall

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