Products

As well as creating customised content, E-Learning Guru have joined forces with Peter Stewart Associates (PSA) to develop and supply generic e-learning modules covering the following:

These modules are lessons containing PSA audio visual presentations, that are off the shelf and can be integrated into a Learning Management System (LMS) or delivered from an intranet.

  • Introduction to GMP for Toiletries and Cosmetics
  • What's So Special About a Medical Device?

    •  A General Introduction to GMP

    A short induction programme, suitable for any new employee working in the pharmaceutical and healthcare industry for the first time. The emphasis is on accountability in what they do - in every part of the organisation - and personal responsibility to the people who use their products.

      -Run time: 20 minutes with assessment
      -Demo Available:
      -Price on request

     Batch Manufacturing Records and GMP: Version 1

    For process operators involved in the formulation and manufacture of medicinal products in final dosage form.

    Draws a distinction between manual batch records and electronically generated batch records. Follows the same theme as (1), but with examples of GMP set in a chemical processing environment.

    -Run time: 30 minutes with assessment
    -Demo Available:
    -Price on request

     Batch Manufacturing Records and GMP: Version 2

    For process operators employed in the manufacture of active pharmaceutical ingredients.

    What is a batch record and where does it originate? Why do we need a batch record and who else uses it? The significance of signatures and counter-signatures. The basic rules for hand written data. Final release of batch records and the role of a Qualified Person.

    -Run time: 30 minutes with assessment
    -Demo Available:
    -Price on request

     Packaging and GMP

    For operators working on packaging lines.

    Personal hygiene. Line clearance procedures. Avoiding mix-ups. Packaging instructions. On-line checks and controls. Importance of following validated procedures. Documentation. Rules for handwritten data. Signatures. Reconciliation.

    -Run time: 30 minutes with assessment
    -Demo Available:
    -Price on request

     Standards of Maintenance and GMP

    For maintenance personnel who work in pharmaceutical manufacturing areas, including instrument mechanics.

    Examples of good and bad practices. Personal hygiene and protective clothing. The risk of contamination and cross-contamination. Record keeping and rules for handwritten data. The importance of following laid down procedures (SOPs).

    -Run time: 30 minutes with assessment
    -Demo Available:
    -Price on request

     Warehouse Procedures and GMP

    For all warehouse personnel.

    GMPs involved from the receipt of raw materials, through to the dispatch of packed stock. Importance of checking identity of materials. Guidelines for handwritten data. Status labels. Traceability. Care in the physical handling of goods. Order picking and dispatch.

    -Run time: 30 minutes with assessment
    -Demo Available:
    -Price on request

     Contamination Control

    A series of three modules which examine, in uncomplicated terms, the most common causes of product contamination, their origins, and methods of control.

    For all personnel employed in storage areas, and in the manufacture and packaging of healthcare products.

     Pharmaceutical Hygiene - Part 1

    The potential consequences of distributing a contaminated product. Common sources of product contamination. Methods of detecting the presence of contamination. A basic introduction to microbiology. Personal hygiene and protective clothing. The importance of good housekeeping.

    -Run time: 30 minutes with assessment
    -Demo Available:
    -Price on request

     Pharmaceutical Hygiene - Part 2

    Checking each delivery of raw materials. What to look for. Storage conditions. The risk of 'adulteration'. Process water as a potential source of contamination. Environmental and particulate contamination. Cross-contamination.

    -Run time: 30 minutes with assessment
    -Demo Available:
    -Price on request

     Pharmaceutical Hygiene - Part 3

    Suitable as an induction programme for granulation operators. Why granulate? Equipment used for granulation. Basic principles of granulation. How granulation is achieved. Problems that can arise during the granulation process. The effect of problems during granulation at the compression stage.

    -Run time: 30 minutes with assessment
    -Demo Available:
    -Price on request

     Tablet Compression Faults

    For newly qualified and experienced tabletting operators.

    This video refers to the rotary tabletting press and examines the most common types of tablet imperfections which occur at the compression stage, i.e. binding, sticking, capping, laminating, chipping and cracking. It discusses the likely causes and what (if anything) the operator can do to rectify the situation. It also refers to adverse conditions at the granulation stage, which may also be the cause and therefore outside the operator's control.

    -Run time: 30 minutes with assessment
    -Demo Available:
    -Price on request

     Principles of Granulation

    Design of equipment and facilities in order to keep contamination under control. Importance of following validated cleaning and sanitising procedures. Using approved materials. Importance of drying equipment after cleaning. Potential harm in allowing water to stagnate in vessels and equipment. Protection of equipment after cleaning. Documentation. The impact of maintenance work in relation to pharmaceutical hygiene. Cleaning floors. Sanitising drains.

    -Run time: 30 minutes with assessment
    -Demo Available:
    -Price on request

     Good Control Laboratory Practice

    Part 1

    GCLP and its contribution to GMP. Importance of complying with Standard Operating Procedures and Methods of Analysis. Consequences of non-compliance. Dealing with samples. Equipment:- calibration, SOPs, checking before and after use. Reference standards and working standards.

    Part 2

    Record keeping. Analytical tests and assessment. Basic rules for compliance. Analytical reports. Standards for hand written data. Signatures. Computer generated documentation. Security procedures. Storage of laboratory records.

    Part 3

    Safety in a laboratory. Safe handling of laboratory waste. Accidents:- handling glassware, spillages, burns, fumes, etc. Good house-keeping. Responsibility to others. Personal hygiene. COSHH regulations. Reporting of potential hazards.

    -Run time: 30 minutes for each part with assessment
    -Demo Available:
    -Price on request

     Drug Substance Synthesis

    Where does GMP begin in R & D? How does GMP in R & D, differ to GMP as it applies to the manufacture of medicinal products for sale? The rationale of documentation as a means of providing a system of information and control. Process controls. Contamination control. Explanation of the terms Validation and Qualification.

    The video gives some practical advice (in terms of do's and don'ts) and underlines the importance of being in compliance at all times.

    -Run time: 30 minutes with assessment
    -Demo Available:
    -Price on request

     Manufacture of Medicines for Clinical Trials

    The concept of GMP in an R & D environment. The difference between producing medicinal products for sale and producing development products for clinical trials. Regulatory Authorities and site inspections. Documentation in R & D, its significance and purpose. Contamination control. Cleaning and cleaning validation. How clean is 'clean'? The principles of Validation and Qualification.

    The video gives some practical advice (in terms of do's and don'ts) and underlines the importance of being in compliance at all times.

    -Run time: 30 minutes with assessment
    -Demo Available:
    -Price on request

     Packaging of Medicines for Clinical Trials

    The differences between packaging medicinal products for clinical trials and packaging medicinal products for sale. Operating procedures. Cleaning. Potential sources of contamination. Documentation. Consequences of failure to work to GMP. What else can go wrong?

    The video gives some practical advice (in terms of do's and don'ts) and underlines the importance of being in compliance at all times.

    -Run time: 30 minutes with assessment
    -Demo Available:
    -Price on request

     A Regulatory Inspection: Version 1

    For all personnel on site who need to fully understand the importance of a Regulatory Inspection.

    It is vital that a Regulatory Inspection runs smoothly and to this end much will depend on the co-operation of all personnel who may be involved. They need to understand who the Inspectors are and the reason for an investigation on site.

    The video gives some practical advice (in terms of do's and don'ts) and underlines the importance of being in compliance at all times.

    -Run time: 30 minutes with assessment
    -Demo Available:
    -Price on request

     A Regulatory Inspection: Version 2

    For all personnel on site who need to fully understand the importance of a Regulatory Inspection.

    Identical to A Regulatory Inspection (1), modified to reflect the same messages for personnel employed in the manufacture of active pharmaceutical ingredients (APIs).

    The video gives some practical advice (in terms of do's and don'ts) and underlines the importance of being in compliance at all times.

    -Run time: 30 minutes with assessment
    -Demo Available:
    -Price on request

     Introduction to GMP for Toiletries and Cosmetics

    Suitable for the induction of all personnel involved in the manufacture, packaging and storage of toiletries and cosmetics.

    Written and produced in collaboration with members of the CTPA GMP Sub-committee. Emphasises the need for quality systems to meet customer expectations. Storage conditions. Bulk manufacture. Packaging. On-line tests and controls. Personal hygiene. Contamination and contamination control.

    -Run time: 30 minutes with assessment
    -Demo Available:
    -Price on request

     What's so special about a Medical Device?

    For production employees of medical device companies who may be unfamiliar with the concept of Current Good Manufacturing Practice (cGMP).

    The aim of this presentation is to define the meaning of QUALITY, regardless of the enormous diversity of products classified as Medical Devices.

    The presentation takes account of regulatory guidelines ISO 13485 and 21 CFR 820.

    -Run time: 30 minutes with assessment
    -Demo Available:
    -Price on request

    VAT must be added to the list price for all EU countries.
    Content available in DVD or Video (without assessments)

    Contact us at info@elearningguru.ie for a more information or to avail of free trial.

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