Early career professional?
We teach, coach and work with the new professionals in the bio/chem industry and help them get a firm grip and foothold
Safe Products, Laboratories, Animals, Environment, and Project Managers … Safer World
We Make Hard Tasks Simple
We meet you where you are. We listen before we talk. We serve in several think tanks and on advisory boards where we contribute with robust Biorisk management strategies and sustainable approaches.
Seasoned professional?
We provide easy costumizable templates, systems, tools and documents to those who can handle the rest on their own
Owerwhelmed??
We support during hard times and are available when you need support or ideas on how to run smarter not harder
Need Rescue?
We assist with SME support if the GMP inspection or commissioning phase failed and you need ideas to get the project back on track
Project Management
Have you defined expectations, progress, milestones ... and identified potential roadblocks?
"Excellence is a habit"
*Aristoteles
Serves as a bridge between the client and the A&E company
Vipsit captures the outside and the inside perspective at the same time. Vips has throughout her career served in roles on all sides of the table (client, production manager, consultant, lab designer, agency representative, trouble shooter, reviewer, GMP and containment inspector), and served in review boards of some of the most important risk management, construction guidelines and standards in the field.
COMMISSIONING: We hired Vips to salvage what could be saved and bring a derailed lab design project back on track. What came as a pleasant surprise to us was that Vipsit was able to think our staff members into the final GMP commissioning phase as testing and monitoring staff. Our maintenance engineers came out on the other side fully trained in startup and shut down of big utility systems due to their participation with reviewing the commissioning protocols and assisting during the 3-month long systems validation test phase.
DESIGN REVIEWS: Vips assisted with review of 30% and 60% design documents, compared the requirements to existing GMP and high containment guidelines and developed a gap analysis of what was still missing in the proposed project design, and gave us the “why” as well.
RISK ASSESSMENTS: It has been a pleasure to have Vips on our side during the preparation for the recent FDA GMP inspection of our new production line. Who knew that multi dimensional risk assessments is a team sport – and actually can be fun!
HARD AND SOFT SKILL SETS: New production facilities can be a blessing and an opportunity for changing old habits, but also a challenge for seasoned staff. We had not truly anticipated and foreseen the dynamics and effort it can take to make this transition smoothly. Vips possesses a unique combination of hard technical and soft people management skill-set that, when used together, indeed makes the transfer to new localities and transformation of mindset less painful for both leadership and production staff.
SHE DOESN'T NEED A HOBBY: Vips works in practically any time zone and environment, face-2-face, Skype/Teams/Zoom or cell phone. In a car driving through Sinai desert, on a road side in an African rainforest, on a river boat on Yangtze, at conferences, at football and baseball games, at your place, the garden, airport lounges, sidewalk cafes or from her home office. She seems to enjoy her work more than most people enjoy a hobby.
CHAOS PILOT: Vips reminds me of a structured and controlled chaos pilot who can navigate safely through all phases of combinations of GMP and biocontainment projects from the pre-design phase through detailed design, construction follow up to the final operational readiness phase and merge into the final hand over with a well planned operation and maintenance program.