The PHSS offers a range of high quality "in-house" training programmes tailored to suit your organisations requirements - with minimal impact on time and budget.
The following courses are available for a minimum of 10 people.
Practical Isolator Training Course - 1 Day
Aseptic Processing, Advanced Pharmacy and Sterility Test Isolators, Their Roles Classification, Disinfection, use and Environmental Monitoring Requirements
Understanding Cleanroom Regulations Technology and Standards - 1 Day
An intensive 1-day Training Course designed to prepare pharmaceutical industry professionals for the effective operation and updating of existing facilities and the development of new assets. Including the NEW FDA Aseptic Processing Guidance and Developments in Annex 1 of the EU GMP.
Risk Assessment in GMP - A Practical Approach - 1 Day
The Regulatory Basis for Risk Assessment in GMP, Established Industry Risk Assessment Systems, Using Baseline Guide 5 to determine validation critically, Failure Modes and Effects Analysis, Using FMEA to determine process equipment risk, Forming the Risk Assessment Team, Hazard and Critical Control Point Analysis, Applying HACCP case study, Post Implementation, Risk Assessment - Essential Tool or Industry Fad?
Computer Validation for the Non-Specialist - 1 Day
The goal of this course is Computer Validation for non-specialists. To establish what Computer Validation is all about, how to go about monitoring a project where it is involved, determining how much is enough. Understanding the terminology, activities as well as some understanding of the theory behind the process. Actual practical exercises are completed during the course with case studies to demonstrate the theory to enable understanding.
Pharmaceutical Water - 1 Day
When designing a complete Purified or Water for Injections water system the starting point is always the point of use requirements. The system design is then generated by working backwards from the points of use and ending up at the connection to the incoming potable water supply. This one day course will follow this design process and will cover the decisions that are made about the technology selection, equipment sizing, control and monitoring and maintenance options.
Isolators and RABS - 1 Day
This course covers design fundamentals through to qualification and regulatory compliance for Pharmaceutical and Healthcare (Pharmacy) Isolators and RABS. Where you are considering specifying, operating, managing or qualifying an Isolator/ RABS system this course will cover both the basics and complex issues using a presentation format to lead discussions.
Cleanroom Clothing - Systems Options and Solutions - 1 Day
The course provides essential training for those who work in and around cleanrooms; delegates will reap the benefit of having the opportunity of one to one tutoring. The course is excellent for those with little experience of the Cleanroom environment, or individuals who simply wish to update or refresh knowledge.
Sterilisation Basics - 1 Day
To provide delegates with a good working understanding of sterilisation processes and sterilisation equipment found in the Parenteral and Laboratory environment.
Risk Management of Contamination (RMC During Manufacturing Operations in Cleanrooms - 1 Day
This course will provide a basic understanding of Risk Management of Contamination (RMC) system that can be utilised for the control of contamination during manufacturing operations in cleanrooms. This was first published in the joint PHSS / Scottish Society for Contamination Control Technical Monograph No.14. Some further enhancements to this monograph, resulting from ongoing risk assessment experiences, will also be included.
Effective Investigations and Corrective Actions- 2 Day
When unexpected events happen - you cannot follow an SOP and need to deviate from it, or you obtain an Out-Of-Specification test result, or your supplier's raw materials marginally fails specification and you desperately need the material - what do you do? A few years ago, the standard reaction to an unexpected event was to either to ignore it, it might go away, or fixit. Today such reactions are unacceptable when working in a GMP environment. Not only do you need to investigate the event to determine what happened, but you need to figure out why the event happened, and then to resolve the event in a manner that prevents its recurrence. This course teaches tools and techniques that can be employed to get to the root cause of unexpected quality events, and to resolve them in a manner such that they stay resolved in GMP manner.
Cleanroom Contamination Control and Monitoring- 2 Day
This course covers the following areas. Design for Contamination Control, Cleanroom Microbiology, Cleaning and Disinfection, Qualification and Regulatory Compliance, Environmental Monitoring, High Level Disinfection - H202 Sporicidal Gassing / Fumigation, Particle Monitoring, Viable Particle Monitoring, EM Data Results Trending Software, Made Issues and Concerns reported by Regulators
If you have any enquiries on the above courses or any other in-house training that we may be able to support you with, please do not hesitate to contact the PHSS office to discuss further.
02/03/2017Latest Edition EJPPS Volume 21 issue 4
23/01/2017PHSS Annex 1 Impact Statement 2017