"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
- Develop your QA role
Strengthen the Team Spirit within the company, fight the "Us vs. Them" mentality
No matter what you are working with, you have one thing in common with all others within the organisation - there are always people who need to be convinced, motivated and inspired. Working in QA means that there are high and sometimes conflicting demands on you from both the authorities and the organisation.
The quality function of the company has an overall responsibility and should be independent of the business operations. Although we wish that "everyone" should take responsibility for quality, we sometimes tend to think in terms “us vs. them”. How should the quality function within the company both create a quality mind set within the organisation to encourage improvements and at the same time keep enough independence and so-called "QA Oversight"?
”If you talk to a man in a language he understands, that goes to his head. If you talk to him in his language, that goes to his heart. – Nelson Mandela
The course assumes that you have basic knowledge of the GMP compliance requirements for QA/QC responsibilities. The course is preceded by a questionnaire with a number of questions we would like you to answer. This is to make it possible to adapt the course to your needs and desires.
We review different tools for clear communication about e.g. requirements and expectations in different situations. These tools may help QA staff to be seen as positive leaders that inspires quality work - ambassadors for quality that has the overall understanding of the requirements and expectations.
We train the course participants to communicate with confidence so that the members of the organisation are willing to accept and act upon what is communicated. The structures and tools we use during the training can be applied in both large and small context.
During the course we mix presentations, workshops, case studies and practical exercises. The course is led by internationally renowned trainers in leadership and communication.
The course is carried out over 2 intensive days and there will be 2 trainers working interactively with the participants. We aim for a high pace to make the course as efficient for the participants as possible. We always start from the participants' professional reality.
- Building confidence in you and your professional role
- Speaking audience-friendly and engaging, so that a positive interest is awakened
- Anchoring a message and motivate your audience to action
- Manage critical situations such as comments and objections
- Anchor ideas and changes
- Nonverbal Communication
Who should attend:
Employees within the quality function who in their daily work must deal with, discuss, argue and justify GXP issues. This course is for you who want to develop your role within the QA organisation and help your business to improve the quality system operation.
Training objectives - enhance the understanding of:
- Improve your ability to influence and persuade by master the tools and to be able to communicate in a way that arouses interest and getting others to act on what is being said.
- Learning how to manage stress and nervousness during confrontations.
- Turning situations into a positive and common goal.
Need for knowledge:
- You should have a thorough knowledge of GXP and/or Quality Systems .
- You should have at least 3 years experience of working with GXP / QS-related issues in the pharmaceutical and / or medical device operations.
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.
Pharmaceutical and Medical Device
EU and US
Date, location and venue:
29-30 May 2018, Copenhagen, Denmark
(Entrance from Kvægtorvsgade)
This course is offered in-house.
Click here for more info and inquiry form.
Day 1: 10.00-17.00, Registration 09.30-10.00
Day 2: 08.30-15.00
14 400 DKK (€ 1 925)
incl. course material (pdf), lunch 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.
* If you still want a printed course handouts binder from us, we charge 50 Euro/pcs (of which 10 Euro to TRINE for clean energy projects)
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.