"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"

Compliance Seminars®

Training session

From Training to Learning
- Improving GMP Performance

This critical workshop thoroughly covers the best way to convey your GMP knowledge to your staff efficiently, accurately and effectively.


Course description:

Through a series of hands-on exercises, you'll develop and deliver a clear and concise GMP training program that will fully prepare your employees to handle GMP with confidence. At this workshop, you will:

  • Examine training systems and programs at use in the pharma, medical device and other industries
  • Identify current expectations that regulatory agencies and quality auditors have of training systems and programs
  • Use a systematic approach to decide when training is — and isn't — a useful solution to deviations and problems
  • Examine models that are used to efficiently design and produce training solutions that meet specific goals
  • Design a training solution that would be suitable for "ongoing" or reinforcement training of operations, staff, technical and management personnel
  • Discover how the way procedures are written can help — or hurt — training efforts
  • Discuss 5 ways to assess individuals and evaluate training effectiveness

Course content:

DAY ONE

  • Training — a cost or investment?
  • Regulatory expectations for training
  • 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
  • Building a successful training program
  • Learning plans or curricula
  • Considering the learners as part of the training solution
  • What qualifies a trainer?
  • What is an expert?
  • Approaches used to design and develop training courses
  • Authentic learning — matching learning methods to the job to increase success

DAY TWO

  • Keys to a successful training system – quick review
  • Assessment and evaluation — how can you measure success?
  • Alignment: Making sure all the pieces fit
  • Other ways to get people involved
  • The connection between training and procedures
  • Tools that support performance
  • Evidence of training 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
  • Managers
  • 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

 

James Vesper - Mentor, video

 

Gate2GMP®

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 »

 

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.

Make an enquiry

 

Register  

 

Course facts

Course no:
5232
Industry:
Pharmaceuticals and Biopharmaceuticals

Level:
Intermediate
GMP region:
US and EU

Language:
English

Date, location and venue:

Preliminary april/may 2018, Copenhagen, Denmark

This course is offered in-house.
Click here for more info and inquiry form.


Time:
2 days
8.30-16.30 (Registration 08.00-08.30)

Price (excl. local VAT):
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.

Discounts:
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.

Course material (Handouts)  
No printed course material will be provided on our courses*.
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 policy - Compliance Seminars®  

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.