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Regulatory Compliance
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Michael Vidal
Senior Pharmaceutical Scientist,PHD Biochemistry, MA Organic Chemistry, MA Biochemistry
My expertise is in the area of product transfer, process development and process validation. In a nutshell I deal with technical operations that have to do with the development of processes all the way to bring them to a commercial scale development. Afterwards we challenge the process utilizing regulatory standards to make them comply and ensure a commercially stable and viable product.
I have analyzed areas of production that had been running with deficiencies and have developed corrective actions to ensure better operations processes. Some of my initiatives have also helped design specific courses of action for the granulation preparation process for one of the largest pharmaceutical in the world in a plant that they manufacture the 90% of their global demand.
Some of my responsibilities are to identify where are the series of causes that eventually would be documented as interruptions of processes for further analysis and come up with solutions to avoid their reoccurrence. . -
Arsenio Sánchez
BS Mechanical Engineer
My areas of expertise are in IT, Infrastructure and Compliance.
I was the dedicated contractor for the validation of applications for the whole pharmaceutical sector for Johnson & Johnson in three US and two Puerto Rico's cities.
My main goal has been to help our clients comply to 100% with applicable laws within the markets they operate.
My commitment is to provide our clients with effective solutions to common problems utilizing the best quality technology available.
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Angel Robles
BS Mechanical Engineering
Since 2006 I have been managing computer systems validations directly linked to Air Handling Units and engineering utilities. I have been deeply involved in dealing within the regulatory requirements of FDA regulated pharmaceutical industry. I define Regulatory Compliance as a set of rules that we have to follow to comply with everything related to manufacturing for the pharmaceuticals industry. We have to make sure that the production outcome complies with stated characteristic, purity, effectiveness and chemical composition.
In recent times regulations requirements had been increasing and our challenge has been geared towards ensuring that our clients can comply in every aspect. One of my biggest satisfactions is every time we can conclude a project within the allotted time and the client can feel safe that our commitment will protect them from any regulatory investigation. We make sure that the processes are being done as documented.JCA was the first organization that provided me with the opportunity to work as a consultant. At first I was concerned about the instability that I thought I was bringing into my life. Looking back I would never regret this decision. I have exposed myself to many cultural changes and there have always been more rewarding opportunities that I never thought possible. I like working as a consultant because I can enjoy the rewards of a job well done and I know that the inspiration came from the job itself.
Regulatory Compliance
Quality is about achieving customer's expectations. That is why it is so critical for the regulated life sciences industry to assure that their manufacturing units, their processes, procedures, and documentation are properly orchestrated to assure the product produced has the identity, strength, composition, quality, and purity that it is represented to possess.
Our team has the experience and the discipline required to support your operation compliance requirements.
- Computerized Systems Validation
- Equipment Validation
- Facilities
- Process Validation
- Commissioning
- Product Transfer
- Control Systems like: SCADA, Weight Scale, Fette, Tester, Coating Pan, Water System
- Applications Platforms including Intouch Wonderware, Rockwell Software, Siemens, Panel View, Versa View, PLC, Crisp/32, Advisor
- 21 CFR PART 11 Assessments and Validation
- VP, URS, TS, IQ, OQ, PQ and SOP Document Development
- Compliance Studies and Audits (e.g. CAPA investigations)
- Building Management Systems Validation
- Compressed Air Systems Commissioning
- Information security and availability Solutions
- Analytical instruments like: HPLC, GC, TOC, UV, FTIR, LAC/E
- Laboratory Applications like: Empower, LIMS, Labware, SmartLabs
- Building Management Systems
- Air Handling Units Equipment
- Calibration and Work Order Systems including Maximo / SAP
- Water Systems
- Security Control Systems
Industry focused staffing services
By leveraging our extended resource pool and our in-depth experience supporting the life sciences industry we can provide focused staffing services to your organization. High quality professionals are available to support your key initiatives covering ranges of expertise like:
- Process Engineers
- Process Scientists
- Validation Engineers
- Regulatory Affairs Specialists
- Document Control Specialists
- Technical Services Specialists
- CAPA & Non Conformance support personnel
- QA Specialists
- QA Change Control Specialists
- Procurement/Logistic Services
Our ever-growing workforce is carefully selected to have a perfect balance between education, experience and passion. We understand the criticality of matching service requirements and resource capabilities in order to achieve success. That is why we put great emphasis on our workforce continues education plans and we provide structured programs based on knowledge transfer sessions (KT), instructor lead trainings, computerized learning tools, mentoring programs aligned with market needs, resource development plans and aspirations.