Make biomanufacturing development/research presentations
Overview
This standard identifies the competences you need to make biomanufacturing development/research presentations, in accordance with approved procedures and practices. You will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Manufacturing Practice (GMP). You will also be required to present records and details of your biomanufacturing work to the appropriate people.
Your responsibilities will require you to comply with organisational policy and procedures for making presentations for biomanufacturing development/research purposes, and to report any problems that you cannot personally resolve to the relevant authority.
Your underpinning knowledge will provide a good understanding of general and discipline-specific existing/new product development principles and processes, and you will also be fully conversant with organisational procedures and systems. You will be required to report any problems with the biomanufacturing activities that you cannot personally resolve, or that are outside your permitted authority, to the relevant people.
Your underpinning knowledge will be sufficient to provide a sound basis for your work, and will enable you to adopt an informed approach to making presentations for development/research purposes, in accordance with approved procedures and practices. You will have an understanding of the manufacturing methods and principles used, in adequate depth to provide a sound background for carrying out the biomanufacturing activities to the required specification.
You will understand the safety precautions required when carrying out the biomanufacturing activities for scientific operations and processes. You will be required to demonstrate safe working practices throughout, and will understand your responsibility for taking the necessary safeguards to protect yourself and others in the workplace.
This activity is likely to be undertaken by someone whose work role carries out Science/Bio manufacturing work activities. This could include individuals working in the following industries, Chemical, Pharmaceutical and Life Science industries.
Performance criteria
You must be able to:
P1 ensure that your work is carried out in accordance with standard operating procedures
P2 wear the appropriate personal protection equipment (PPE) when working in the biomanufacturing environment
P3 establish the scope and purpose of the development/research presentation to be delivered
P4 determine quality, cost and delivery issues and the resources needed to deliver the presentation
P5 present the data in an appropriate presentation format and structure for the audience
P6 obtain appropriate equipment and resources, and verify their fitness for purpose
P7 deliver the prepared presentation in the correct medium for the audience
P8 ensure that the audience has the appropriate post-presentation media to support the presentation
P9 communicate the required information about the work done, to senior management and other authorised people, in accordance with organisational procedures
Knowledge and Understanding
You need to know and understand:
K1 the health and safety requirements of the area in which you are carrying out the biomanufacturing activities
K2 the implications of not taking account of legislation, regulations, standards and guidelines when conducting biomanufacturing activities
K3 the standard operating procedures, as set down in local biomanufacturing operating manuals
K4 the importance of following equipment manufacturers’ operating instructions
K5 the principles of Good Manufacturing Practice (GMP) applied in the workplace
K6 the importance of wearing protective clothing, gloves and eye protection when handling materials (including biochemical substances, biological pathogens and/or antigens), and the equipment used to contain and process them
K7 the manufactured product and batch process tracking and records system
K8 the types of handling and sorting system, and the procedures used for products undergoing processing in the manufacturing facilities
K9 the importance of correct identification, and any unique organisational or manufacturing numbers
K10 the organisational requirements for maintaining the security of the workplace
K11 the lines of communication and responsibilities in your department, and their links with the rest of the organisation
K12 the limits of your own authority and to whom you should report if you have problems that you cannot resolve
K13 the different types of laboratory audience, and their needs
K14 the purpose of the presentation, and your key messages
K15 the time available to make presentations
K16 the advantages and disadvantages of different methods of presentation delivery
K17 the materials that are appropriate to support presentations (including handouts, samples)
K18 how to use the presentation equipment
K19 the questions you might expect to receive as a result of the presentation
K20 the handouts that can be used to support a development/research presentation
K21 factors that can effect or influence the impact of a presentation (including room configuration, audio-visual systems (including microphones), dress code)
K22 any presentation venue health and safety considerations to be taken into account
Scope/range
1. carry out all of the following activities:
1.1. plan the presentation in a logical and structured way for the briefing
1.2. prepare the content to meet the needs of the target audience
1.3. rehearse the presentation, and amend as appropriate for the content and delivery timescale
1.4. prepare supporting materials (eg, handouts, copies of slides)
1.5. prepare answers to anticipated questions
1.6. use the equipment correctly to deliver the planned presentation
1.7. answer audience questions
1.8. issue the appropriate handouts to audience following the presentation
deliver presentations to both of the following laboratory audiences:
2.1. small groups
2.2. large groupspublish technical reports in both of the following formats:
3.1. draft form
3.2. final versionrecord details of the work, and communicate the details to the appropriate people, using:
4.1. verbal report
Plus one method from the following:
4.2. written or typed report
4.3. specific company documentation
4.4. computer-based record
4.5. electronic mail