Vipsit provides training courses in all our competence areas as listed on this website. We customize the training to your need. We can train on site or, for some topics, remote.

Before we say yes to a request we want to understand:

• Topic?
• Who is the audience? Technicians, PhD’s, mangers, engineers, architects, mixed?
• What is their present background within the topic? None, a little, some, a lot, it depends?
• How much time has been allocated?
• When would you like it to happen?
• What would you like them to Know and be able to Do afterwards?
• And according to Bloom’s taxonomy, what outcome would you want for the selected audience?

BLOOM’S TAXONOMY

While our courses do build on PowerPoint slides, most have interactive group and post-it brainstorming exercises built in.

COURSES

Below, a few selected examples of previously taught courses are listed. If we have not developed the materials yet, we will and will do so according to your needs. In all situations we will customize training to your audience profile before execution.

BULLET-POINTS DO NOT KILL PEOPLE – PEOPLE KILL PEOPLE

Presentation techniques: Power point presentations – (bullets do not kill people, people kill people). How to make your presentation memorable. What to do and what not to do – 1 hr

GMP

GMP & Biosafety. Designing large scale facilities with conflicting guidelines in mind – 4 hr

GMP. Disposables used for biologicals. They may be closed systems, but are they robust? – 1 hr

GMP AND MORE. Methods to solve overlapping rules and guidelines. Who should win when both inspectors cannot have it their way? – 2 hr

LARGE SCALE SPILL HANDLING

Procedures for handling large scale spills . Why are normal procedures not adequate when your spill is large enough to swim in? – 2 hr

Designing for large scale spills. What features should be added during design phase? How to commission for spills – 2 hr

RISK ASSESSMENTS

Impact assessment – why the containment industry should borrow from the GMP world. How can applying GMP tools enhance the environmental, personal and animal safety. – 2 hr

Communicating risk and mitigation measures with management, inspectors, first responders and other important stakeholders or “how to get people to understand the risks you are talking about” – 3 hr

Picking the cherries from DQ, IQ, OQ and PQ in GMP for sensible biosafety validation – Getting it right the first time – 1 hr

BIOSAFETY

Biosafety Basic in the GMP world – Course in biosafety and GMP/containment  for institutions and companies. A full 5 day course, lectures and practical training – 5 days

Basic Biosafety and Containment Challenges for Architects and Engineers. Terms, definitions, guidelines and best practices. Where do the large scale GMP guidelines clash with traditional containment guidelines, and what can be done about it? – 5 days

Safety in Large scale productions and associated laboratories – Best practices, and what not to do – 2 hr

Laboratory Acquired Infections (LAIs). Why are Risk group 2 agents the biggest cause of LAIs? – 3 hr

The battling guidelines field. CWA 15793, 16335 and 16393, and why the GAP III guidelines is the first example on a GMP/BRM guideline with actual solutions. How can GAP III be applied to other fields? – Performing gap analyses, project management and changing the institutional culture – 1 day

DESIGN & CONSTRUCTION

GMP and containment design for architects and engineers, short course, highlights. 6 lectures on prudent design solutions, and lessons learned – 2 days

Designing facilities with terror threat in mind. What added features should be considered for securing your facility? Why are GMP facilities already surprisingly secure, and are there anything missing for these large scale productions?- 2 hr

Designing for large scale spills. What features should be added during design phase to prevent large volume spills in vaccine facilities? How to commission for spills – 2 hr

The clients role during the design and building process. Due diligence and being prepared to receive the A&E company. Ways to survive without killing the contractor or committing ritual suicide – 3 hr

Managing your building project and getting what you want – Why does Impact Assessments (IA’s) analyses from the GMP industry have a larger potential, and why have other industries not yet adapted these tools> Documenting the design intent – 1 hr

Construction noise. Is it a problem during animal facility refurbishment projects? How much noise does a grinder, a drill and demolition create? What are the frequencies? And what can the animals hear? Do they even care? – 1 hr

OPERATION AND MAINTENANCE

GMP facility maintenance strategies and performance indicators. What do we measure and why? – 10 hr

HEPA filters – From theory to practice. What do you do when water is dripping out of the filter box? What is the maintenance frequency, and why. Is there a difference when they serve the supply or exhaust system? – 5 hr

COMMISSIONING, QUALIFICATION AND VALIDATION

Validation of autoclaving procedures. How can we use the GMP sterility validation approach for our decontamination cycles? Why even validate? Can you autoclave animals? Does it smell? How does it look? How to identify the cold rabbit, where to place sensors – (1 hr)

The GMP qualification process adapted to containment facility design and delivery – 1 hr

Risk assessments in large scale GMP production – What specific risks come on top of normal biosafety – 2 hr

Validation by design – Can you do short cuts in your validation studies? How can you space your testing protocols in an n-dimensional grid and still cover all the bases while reducing the number of validation tests? – 2 hr

BIOSAFETY PROFESSIONALS

Biosafety Officer! Now what? A survival guide for new BSP’s in the field. How do you win over the old grumpy scientist that sees you as a nuisance, and knows so much more than you do? What soft leadership skills can you apply when you have to lead with only your winning personality and no formal authority – 4 hrs

Designing Training Programs for a learning Environment, Adult learning techniques, challenges and success models – 8 hr

Training Biosafety Training. An interactive course analyzing different training tools, strategies and their usefulness in different scenarios. Where does GMP fit in? And where does it not? – 10 hr

Personal relations and management. Building confidence between the BSP and the scientist. How do we work together instead of fighting each other? What are typical clash areas, and what secret tools can we apply? – 1 hr

ANIMALS

Animals and Biosafety versus safety for the animals. Building design and procedures for safe animal handling. Why are European animal guidelines even stricter than the US AAALAC guidelines – 2 hr

Construction of an animal facility. Lessons learned while building it twice. What went wrong. Case study from Denmark. – 1 hr

POLIO, GAPIII, TRS 629

Polio eradication. Where are we now and what does the future bring? What is the intent from the WHO? And how do they plan to achieve it. – 4 hr

Polio eradication. Historical perspective. The Danish legacy, 70 years of Polio vaccine production. Process development and current production strategy. Why is a non-animal ingredient containing media worth the trouble? – 1 hr

Eradication of pathogens. What does it take? Case study from Denmark and the evolution of guideline development targeting the large scale GMP productions serving in the post eradication era. Why the vaccine producers suddenly becomes a risk factor. How the risk for environmental release suddenly is setting the agenda for low risk pathogens that never were considered to require high containment design. – 1 hr

HEPA FILTERS

GMP, Biosafety, Facility Maintenance & Risk management. Validation of decontamination of a HEPA filter box. Why is it so challenging? What is the users obligation, how can the suppliers assist? With what? When does the suppliers responsibility stop? And how can the owner bring the final validation studies to the final end point – 30 min

BIOSECURITY

Biosecurity. How much regulation is needed? And how much is too much? Case study and comparison between the Danish rigid legislatory approach and the Dutch biosecurity regime with voluntary compliance and self assessment. pro’s and con’s – 2 hr

Implementing the Biosecurity law in a 100 year old institution in Denmark –  “Remind me again why we stored all the samples during the last 100 years?” Deciding what to keep and what to discard. Wrangling more that 1200 freezers and a cold storage site off-campus with more than 300 pallet locations. Case study of implementing the newly issued biosecurity legislation. What was the level of effort, how long did it take? What would we have done differently if we should start again? – 2 hr

Biosecurity in practice. How do we move unknown biological samples to newer, more secure storage? How do we protect and prepare the staff; lessons learned from a 100 year old institution. Case study of how we moved a forgotten stash of toxin with a strength and volume that could eradicate the population of 3 continents. How did we plan, what did we do, and how ded we destroy? – 2 hr

Facility policy development for storage of samples. What can be discarded and what should you keep? – 1 hr