Monday, 21 November 2011

Pharmig Training Packs

Pharmig Training CDs

Pharmig have issued two training CDs ("electronic packs"), designed to promote best practice in microbiology laboratories. They are designed to act as training guides for new laboratory mangers and supervisors and to provide a way for established laboratories to benchmark their systems against current industry standards. The CDs contain notes, presentations and a wealth of forms and templates. The CDs are:
  • Best Practices in Microbiological Documentation
  • Setting up and managing an effective training programme in the microbiology laboratory
The contents of each CD runs (see below):


Pharmig Electronic Pack 1: Best Practices in Microbiological Documentation
Folder
Contents
Notes
A: Introduction
Introduction to the Good Documentation Practice and the contents of the CD

B: General Documentation
B1. A. Confidentiality agreement
B2. Technical agreement
B3. Quality manual
B4. SOP template
B5. Document change form
B6. Internal audit report
B7. Training worksheet
These documents provide examples of the general laboratory documentation required. These are: confidentiality agreement (a pre-requisite for a contract test laboratory to have with its clients); technical agreement (typically drawn up between the client and the test laboratory); the quality manual, required by all GMP inspectable organisations; a generic SOP template, detailing each of the required headings; an example of a form used to request changes to documentation; an example of an internal audit report, as an example of best practise; and an example of training documentation.
C. Equipment Documentation
C1. New equipment approval form
C2. New equipment risk assessment
C3. User requirement specification
C4. Validation master plan
C5. DQ protocol
C6. IQ protocol
C7. DQ/IQ combined template
C8. OQ protocol
C9. PQ protocol
C10. Validation of equipment risk assessment
C11. Validation report
This section of the CD contains eleven documentation examples and templates relating to equipment validation. This consists of a template for approving new equipment and for the related risk assessment for the introduction of a new item of equipment. The form for the user to define the equipment requirements (URS) and an example of a validation master plan. There section includes the various qualification templates for equipment validation: design qualification (DQ), installation qualification (IQ), plus an example of how these two stages can be combined; operational qualification (OQ), performance qualification (PQ), validation of equipment risk assessment, and a generic validation report.
D. Laboratory Documentation
D1. Document distribution form
D2. Document read list
D3. Document reconciliation form
D4. Document request form
D5. Document review form
D6. Document signature list
D7. Equipment clearance certificate
D8. Stability study test protocol
This part of the pack contains the basic laboratory documentation, centred on documentation control. This includes example documentation for distributing documentation between staff, reading lists to demonstrate training compliance, forms of the reconciliation of documentation and review and   signature lists. Also include is a template for an equipment clearance form (required for external examination or calibration of equipment) and an example laboratory protocol relating to a stability trial.
E. Laboratory Test Documentation
E1. Request for analysis form
E2. Additional sample request form
E3. Laboratory validation protocol
E4. Laboratory test sample plan
E5. Autoclave log book
E6. Media QC logbook
E7. Equipment log folder
E8.Example of a test work sheet
E9. Balance logbook
E10. Change control form
E11. Deviation report
E12. Bacterial Endotoxin test method
E13. Sterility test method traceability
E14. Total viable aerobic count method
E15. Out of specification form
E16. Laboratory report template
This section of the pack contains the essential test and analysis documentation for the laboratory. This includes forms for requesting samples for analysis; a template for devising a laboratory validation protocol and a laboratory sample plan. The section also includes example equipment log folders and logbooks (including an autoclave and balance). Other aspects of documentation are covered through change control, deviation reports and out of limits forms. Also included are examples of general test paperwork relating to areas like endotoxin and sterility testing.
F. Electronic Data Management Systems
PowerPoint slides
This section contains a set of PowerPoint slides on the subject of Electronic Data Management Systems and the design of documentation management systems. Reference is made to Good Automated Manufacturing Practice.
G. Documentation Non-Conformances
PowerPoint slides
This section contains a set of PowerPoint slides written by Tim Sandle on the subject of non-conformance relating to documentation. Coverage is given to issues raised by regulatory authorities and to the concept of human error.

Pharmig Electronic Pack 2: Setting Up & Managing an Effective Training Programme in the Micro Laboratory
Folder
Contents
Notes
A: Introduction
Introduction to the Best Microbiology Laboratory Training

B: Induction material
B1. Induction Programme
Induction
 B2. Training Programme
Induction
B3. Probation Review
B4. Job description
B5. Abbreviated CV
This file contains examples of the important forms required for new starter induction, including the training programme.
Also included in this section are a draft job description for a microbiology technician and an abbreviated curriculum vitae.
C. Employee development
C1. Personal development review plan
C2. Personal development review plan continued
C3. Personal development review plan continued
C4. Personal development review plan continued
C5. Personal development review plan for learning and development
C6. Personal development review plan for performance objectives
C7. Personal development review plan for manager and staff review
C8. Personal development review plan for establishment of development needs
C9. Personal development review plan for progress review

This section contains a variety of materials geared towards the new employee induction and development, including the mechanism for capturing and identifying training needs.
The section also includes employee performance objectives.
D. Employee appraisal
D1. Self appraisal form
D2. Appraisal interview summary

This section contains a basic appraisal system framework for both running the review and for the employee’s own self assessment
E. Good Manufacturing Practice
E. Introductory GMP training questions
This section contains examples of GMP training questions, both of a general nature   and in relation to microbiological practices
F. External training
F. External Training and Development
This form is a useful one for capturing the external training that  anew employee has been on and for facilitating feedback and learning outcomes
G. Measuring training
G1. Personal and Development Training
G2. Personal and Development Training SOP
G3. Company training worksheet example 1
G4. Company training worksheet example 2
This section contains the paperwork required for reviewing, measuring, recording and trending training against SOPs. It contains several useful reconciliation tools. This section is presented as an example of best practice.
H. Training in microbiological techniques
H1. General Microbiology
H2. Gram Staining
H3. Aseptic Techniques
H4. Media QC
H5. Environmental Sampling
H6. Sampling & Plate Counting
H7. Identifications
H8. Microbial Limit Tests
H9. Endotoxin Testing
H10. Sterility Testing
H11. Cleaning & Disinfection
This section contains several examples of training in microbiological techniques. This includes the practical areas to be assessed and the types of questions required for assessment and the means to measure competency.
I. Training Non-Conformances
PowerPoint slides
This section contains a set of PowerPoint slides written by Tim Sandle on the subject of non-conformance relating to training issues. Coverage is given to issues raised by regulatory authorities.
J. Train the Trainer
PowerPoint slides
This section contains a set of PowerPoint slides written by Brian Alexander on the how to make a good trainer and the type of training needed for a microbiology trainer.
K. Training matrix
J1. SOP defining the training matrix
J2. Example of a training matrix
This section examines how training can be tracked across the laboratory using a training matrix and how different levels of training, from beginner to expert, can be defined.

The CDs have been written and produced by Tim Sandle and Brian Alexander.

The full references are:

Sandle, T. and Alexander, B. (2011). Electronic Pack 1: Best Practices in Microbiological Documentation, Pharmaceutical Microbiology Interest Group, Pharmig: Stanstead Abbotts, UK

Sandle, T. and Alexander, B. Electronic Pack 2: Setting up and managing an effective training programme in the microbiology laboratory, Pharmaceutical Microbiology Interest Group Pharmig: Stanstead Abbotts, UK

The CDs cost £75.00 ($130) for Pharmig members and £99.00 ($175) for non-members.

Go to: Pharmig publications
Or email: Info at Pharmig

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