"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
Procedures for performance:
Ways to achieve improved performance
Procedures are an important way of describing how a task is to be performed so personnel can perform the task correctly, consistently, safely, and efficiently.
Despite their critical role in making pharma and biopharma products as well as medical devices, writing a clear, easy to follow procedure — and then training people on it — isn’t as simple as it sounds.
Use a structured way to write standard operating procedures (SOPs) and provide the appropriate in order to achieve effective, efficient task performance.
This two-day workshop looks at procedures as one of several methods for managing, capturing, and transferring knowledge. Various formats of procedures will be examined and critiqued along with an examination of current regulatory requirements. Using a unique data collection form, participants will collect information that would be included in a procedure and then write (or re-write) a procedure. Participants will have an opportunity of writing (or re-writing) a procedure based on an actual need they have.
Frequently seen “error traps” in procedures will be examined along with ways to reduce procedure-related “human error” performance mistakes.
GMPs require that people be trained on the procedures before using them but there are a variety of methods that can be used, some of which give higher levels of confidence that people can actually perform the task properly. Different procedure training approaches will be discussed and compared. Ways of assessing performance and evaluating the effectiveness of the procedure training will be examined.
Who should attend:
Those who write or review procedures and those who provide procedure training, including those in quality, operations, technical services, and maintenance/engineering.
- Identify regulatory requirements and expectations related to procedures and training on procedures.
- Discuss how procedures and procedure training contribute to knowledge management.
- Discuss the differences and similarities between policies, procedures, work instructions, job aids, and performance support systems.
- Evaluate several examples of procedural instructions, describing how they contribute or don’t contribute to achieving a goal.
- Discuss common flaws and problems seen in procedures.
- Examine alternative ways (other then text) of providing procedural information.
- Given a task, write a procedure.
- Using a checklist, evaluate a procedure.
- Identify various options to provide training on a procedure including e-learning, “read-and-understand”, and hands-on training.
- Identify various options to assess performance of the procedure and evaluate its effectiveness.
Detailed course outline - Click here (open/close) »
- Workshop Introduction and Objectives
Knowledge management and the role of procedures
- Knowledge management as described in ICH Q10
- Explicit and tacit knowledge
- Sticky and leaky knowledge
- How do procedures and procedure training fit in?
- Regulatory requirements and expectations regarding procedures and procedure training
- Examples of requirements from EU, US, CA, and WHO
- Examples of citations regarding procedures
- What the regulations do not say
- Activity: What makes a good procedure?
- Activity and discussion: Applying the criteria to recipes
- Other examples of procedures
- Level of detail – how much information should be included?
- Policies, procedures, work instructions
- What procedures can look like: alternatives to traditional formats
- Job aids
- Other performance support tools
- Knowing the users
- Flow charting / process mapping
- Who does what?
- Critical hows
- Assess the risks
- Activity: Using a data collection form
- Reviews and approval
- Periodic reviews
- How much should be included in a procedure?
- What the aviation and nuclear power industries can teach us
- Points to consider when writing a procedure
- Activity: ways to reduce error traps
- Activity: Writing (or re-writing) a procedure
- Activity: Reviewing a procedure and giving feedback
- Options – training on individual procedures or competencies
- What does the person need to know: Know about? Know what? Know how?
- The problem with "read and understand"
- Assessments and effectiveness checks
- Activity: Creating a training plan for a set of SOPs
- Checklists – what they are and what they are not
- Other ways to support performance – job aids
- How will you be able to use this information?
- How do you view procedures differently now?
Video presentation of the course subject:
When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
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Bring this course in-house?
Are you a group in need of the same training?
Do you wish to customize this course to suit your needs?
If so, running the course in-house is probably the best and most cost effective solution.
Pharmaceutical, Biopharmaceutical and Medical Device
US and EU
James L. Vesper, PhD
Date, location and venue:
3-4 December 2018, Copenhagen, DenmarkDGI-byen
(Entrance from Kvægtorvsgade)
This course is offered in-house.
Click here for more info and inquiry form.
8.30-16.30 (Registration 08.00-08.30)
Register by 22 Okt: 13 780 DKK (€ 1 850)
and save 1 500 DKK (€ 200)
From 23 Okt: 15 280 DKK (€ 2 050)
Note. Due to tax/VAT regulations within the EU (for courses/seminars/conferences), the course fee is invoiced in the local currency and local VAT is added.
Accommodation is NOT included in the course fee.
For groups registered and invoiced together for the same course we offer the following quantity discount:
2-3 persons 10%
4 or more 20%
Quantity disconts can not be combined with other discounts or offers.
We do not offer or practice any general company discounts without commitments and/or written agreements.
This is primarily to protect the environment. Therefore, we encourage you to bring a laptop / tablet to the course - it is possible to make notes in the PDF file you will have access to.
1-2 weeks prior the course you will receive login details to www.Gate2GMP.com where you can download the course handouts as a PDF.
Note pads and pens will always be provided at the venue.
Cancellation of registration:
Registration is binding and when you have received our confirmation the following conditions are known and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.
All cancellations and/or substitutions must have been communicated with and confirmed by us.
Cancellations received less than 30 calendar days before course start are subjected to a service charge of 150 € (Euro)/registered course day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 7 calendar days prior the course, or failure to cancel or "no-show", will be charged in full.
Cancellation of courses: Courses may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the course start), or due to other reasons beyond our control. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled course. If you need to book flights way ahead (+35 days prior the course) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.