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ATPconsulting
Gabriel Vaideanu
Your Best Business Partner
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Abouth us...
Over 12 years of practical experience in pharmaceutical aseptic manufacturing at TEVA Pharmaceuticals
SME on critical systems like: RO, PW, WFI, CAS, HVAC, PSS, CIP…
SME on critical equipment and processes like: Autoclave, Lyophilizer, RABS systems, filling machines, Media Fill, Process Qualification...
Part of professional training team for new equipment and processes
Part of Improvement projects of processes and equipment for Sterile Plant KFS
Quality leader for all aspects of design and qualification of critical systems and equipment
Lead critical systems and equipment preparation programs for FDA and EU inspection
For the past 7 years, part of a professional team focusing on TEVA's new sterile facility projects around the world (Japan, Hungary, Croatia, Holland…)
Part of management team of three new sterile facility projects in Israel – Kfar Saba including syringes and vials filling lines within Isolators or Open Active RABS
Lead quality and aseptic processes from initial design concepts through to operation and qualification, including regulatory readiness.
Successfully developed and implemented a risk assessment-based approach for commissioning and validation
Significant FDA and EU audit experience.
Speaker in front of more than 200 professional participants from all over the world at
Optima Pharma Forum - Germany – June 2016
ATPconsulting
Do it right for the first time!
New filling line...
Open/Close RABS - Isolator?
Kick Off meeting, Mock Up, Design meetings, FAT …. SAT, Commissioning, Validation ….
We pride ourselves on our deep knowledge, on technological field and regulatory requirements.
We have the experience with the best Pharma equipment suppliers all over Europe.
Your small investment on ATPconsulting, at the beginning of the project, will save a lot of your efforts at PQ and MP stage....
Let us know how we can assist you today.
New Production Facility ...
"Look Back To The Future"
Successfully PQ and Media Fill process starts with a good Lay Out design, HVAC detailed design, Process Mapping, validation based on Risk Assessment Approach, System Impact, Product Impact and right OPIs and SOP in place.
All of this based on your product needs, your regulatory market, your budget and timeline.
ATPconsulting, with a high level of professionalism and years of regulatory audits experience, is the solution for your project success.
Existing systems / equipment
"Continues Improvement"
Frequently needed for old facility or processes, this service has been essential to success on many occasions.
New product, new demands, new market ………
ATPconsulting is the solution for your challenges.
Let us know how we can assist you today.
Existing Process
"Do It Better ..."
Short your turn over time, lower your costs, eliminate your investigations...
Use the newest regulatory requirements and methods for an effective Quality System.
Invest minimum efforts and get the maximum results.
ATPconsulting has the knowledge and experience to do it for you.
Want to learn more about our services? Contact us today.
Get in Touch
ATPconsulting is committed to exceeding your needs. Questions, comments or special requests? Let's do it together...
We’d love to hear from you, so don’t hesitate to reach out today.