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