Pharmaceutical Microbiology (QLP Module 4)
Print
The responsibility of the Quality Leader today demands a unique skill set of technical, managerial and leadership characteristics.
Tuesday 12 to Thursday 14 June 2025
Royal Sonesta Hotel Boston, MA, USA
$2950.00 per delegate. Additional delegates from the same site and early bird discount $2360.00 per delegate
Type: Pharmaceutical
About this course
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 course, for non-biologists and microbiologists, is designed to provide you with the knowledge, confidence and decision making risk assessment skills to prevent this happening.
You will learn:
- The basic characteristics of all microorganisms found in your pharmaceutical environment, how they get there and how you can remove them!
- How you can sample, isolate, count and identify these microorganisms
- How to prevent contamination of our products and processes using practical risk management and risk assessment tools and techniques
- How to interpret microbiological data in order to make the right ‘risk-based’ decisions – decisions that will satisfy the regulators, protect your patient and improve your operational efficiency
How This Training Will Benefit You
Pharmaceutical Microbiology represents a fundamental module of the Quality Leadership Program and knowledge requisite for the Quality Leader and Technical Professional. Whether supporting sterile or non-sterile APIs and dosage forms this knowledge base allows them to make informed, science and risk based decisions to benefit both the business and the patient.
It will provide the background and knowledge needed by every Quality Professional and Technical Leader whether in Production, Quality, R&D, Validation, Engineering, or any other technical discipline. As with all of NSF-DBA’s QLP modules, it is led by industry and academic experts; frequently incorporating case studies and small group sessions to facilitate learning.
NSF-DBA’s format of extended days and pre-work ensures that both you and your company benefit from the learning experience in an efficient way and with minimal time away from the workplace.
The Quality Leadership Program and this module on Microbiology is based upon a key component of the Qualified Persons instruction which NSF-DBA offers in Europe. It sets a new standard for practical, results oriented instruction.
A Certificate is granted by NSF-DBA for attendance. Higher degree options – a Diploma and a Masters in Pharmaceutical Quality and Good Manufacturing Practice from the University of Strathclyde can be obtained by attending the full series.
Course outline
Microorganisms: Understanding your ‘Enemy’!
- The physiology and key characteristics of microorganisms
- Routes of contamination
Microbiological Methods: ‘How to’ Guidance on…
- Methods of sampling
- Isolation and enumeration (counting)
- Methods of identification: How and WHEN to identify microorganisms
- A review of key test methods including the test for sterility and preservative efficacy
- The use of Process Analytical Technology (PAT)
- Rapid (non-culturable) methods
- The microbiology laboratory: What are ‘Good Laboratory Practices’?
- Monitoring methods: How to establish a sensitive and cost effective monitoring program
Microorganisms and your Products, Procedures and Plants
- Raw materials: The microbiological risk assessment and testing of raw materials and non-sterile products. Who must do what, when and how
- Contamination control strategies: How to prevent contamination of your product and plant
- Microbiological aspects of good plant and process design (sterile and non-sterile)
- 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: The principles, practice and validation of
- Moist heat
- Filtration
- Dry heat
- Other methods
- 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
Discussion and Working Groups
A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.
Additionally, discussion periods, provide delegates with an opportunity to obtain answers to their specific questions and concerns.
Venue
Royal Sonesta Hotel Boston, MA, USA
The Royal Sonesta hotel is minutes from downtown Boston. Located
along the Charles River, it is close to many of the Boston historic sites,
including the Boston Science Museum. There is excellent shopping
nearby.
Hotel Accommodation
NSF-DBA has negotiated a preferred rate with the Royal Sonesta
Hotel. A limited number of rooms are available at this rate. Hotel
reservations and payment are the responsibility of each delegate.
We will be happy to help but final confirmation and bill settlement
is the delegate’s responsibility.
There are a number of other hotels located within minutes from the
Royal Sonesta Hotel including the Marriott Hotel, the Courtyard Inn
and Le Meridien Hotel, all situated in Cambridge. Downtown Boston
hotels are within 15 minutes by taxi or public transportation of the meeting venue.
Royal Sonesta Hotel, 40 Edwin Land Blvd., Cambridge, MA 02142, Tel: 617-806-4200.
Tutors
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our experts for this course are:
What you've said
“Very good course that delivered just what I had hoped for – an overall review of Microbiology as it’s applicable to the Pharmaceutical Industry. Instructors are very knowledgeable and up-to-date with current requirements.”
Yvette Tanner, Gilead Sciences
“Applicability of the course material is completely relevant and immediately useful to me. Buzz groups are excellent challenges, really enjoyed the investigation into antacid product complaint investigation.”
Ann Farnsworth, Merrimack Pharmaceuticals
“The tutors were very informative and assisted in making suggestions in regular work processes.”
Kiee Garland, OPK Biotech
“Len was excellent, great addition to have a former FDA person. All tutors were very engaging. Nice balance of material and buzz groups.”
Debra Lane, Shire Human Genetic Therapies
“Found the information relevant. Particularly pleased with exercises.”
Anonymous
An NSF International Company
