"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
From Training to Learning
- Improving GMP Performance
Knowledge management is considered a key enabler of a modern pharmaceutical quality system. This workshop provides participants practical ways of how training and learning contribute to a robust knowledge management program, equipping people with the knowledge and skills they need to successfully and safely do their jobs.
Designed as an advanced workshop, this two-day course examines the fundamentals of knowledge management and its practical aspects that contribute to product and process understanding.
Five learning theories are discussed along with how they can be practically used to support performance and create learning programs that are authentic learning opportunities. Participants use concept mapping as a way of reflecting on the topics covered and how they can be incorporated into their own organization.
Explore ways of moving from the traditional use of training to where learning, knowledge management, and process understanding contribute to better worker performance, compliant outcomes, and high-quality, pharmaceutical products & medical devices
- Distinguish between “training” and “learning.”
- Describe knowledge management, emphasizing the roles of individual and organizational learning.
- Develop alternative approaches to knowledge transfer that are grounded in good learning practices and meet regulatory expectations.
- Identify current expectations that regulatory agencies and auditors have of knowledge management, training systems, programs, and worker performance.
- Examine models that are used to efficiently design and produce training solutions that meet specific goals.
- Discuss different models for assessing and evaluating learning and learning programs.
- Welcome and introduction
- What is this stuff called “knowledge”?
- Tacit versus explicit knowledge
- Knowledge management and what it includes: the knowledge lifecycle
- Regulatory expectations for knowledge management and process understanding
- Moving through the lifecycle: acquiring, analyzing, storing, disseminating
- Compliance failures and training — identifying the causes
- Training is not the answer to all your problems
- Competency-based training
- A quick look at learning theories: how we learn
- What qualifies a trainer?
- What is an expert?
- Keys to a successful training system – quick review
- Assessment and evaluation — how can you measure success?
- Alignment: Making sure all the pieces fit
- Organizational learning – what it can mean for the business
- Beyond training: Other ways to disseminate information
- Procedures and checklists
- The connection between training and procedures
- Other tools that support performance
- Evidence of training, learning, and performance
- Evaluating and enhancing YOUR training program
Who should attend:
- Compliance officers
- Consultants/service providers
- Engineering and design controls teams
- Executive management
- General/corporate counsel
- Manufacturing directors and supervisors
- Medical/technical writers
- Pharmaceutical and cGMP auditors
- QA/QC personnel
- R&D staff
- Regulatory/legislative affairs professionals
- Risk management specialists
- Training personnel
- Validation specialists, scientists, engineers
When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
At Gate2GMP® each course has its own page where you can download course materials, receive up to date information and communicate in the course forum.
Watch this short video to learn more about what Gate2GMP® offers »
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.
Pharmaceuticals, Biopharmaceuticals and Medical Device
US and EU
James L. Vesper, PhD
Date, location and venue:
16-17 May 2018, Copenhagen Denmark
(Entrance from Kvægtorvsgade)
This course is also offered in-house.
Click here for more info and inquiry form.
8.30-16.30 (Registration 08.00-08.30)
14 400 DKK (€ 1 925) incl. course material (pdf), lunches and refreshments
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 we offer the following quantity discount:
2-3 persons 10%
4 or more 20%
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.