 | Services |  | GxP, 21CFR Part 11 (ERES), training, audits, safety, QC/QA, validations |
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Home | Links | Contents | Contact | Search | Company | Validations | Training | Prices | | Services Offered | |  | | It's not only about compliance but also savings of time and money!Increased inter and intra-departmental performance. Reduced wasted capital, time and effort. Increased Customer Satisfaction. Increased Profit.
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| | | | Services are based on 6-sigma (6-σ) and Total Quality Management (TQM) principles / methodology.Validations (Retrospective / Concurrent / Prospective)- Process
- Equipment
- Facility
- Cleaning
- Test Method (TMV)
- Computerized systems (Part 11)
- Client / Server / Network
- PLC
- PCS / SCADA
- Automated System
- Software
- ERP / MRP
- CAPA systems
- Laboratory
- Calibration Management System
- V&V
- Documentation Management Systems
- Design of Experiment Studies (DOE)
- Change Control
- Document Control
- Process Capabilities (Cpk)
- Batch Verifications
- Stability / Kinetics
- PMA / 510K submission help
- INDA / NDA submission help
- Develop Test Methods / SOP's
- Corrective Action / Preventive Action (CAPA)
- Pre-approval Inspection (PAI) Preparation
- Resolve 483's / write-ups, and CD's
- RMA's
- GMP
- QSR
- GLP
- Part 11
- Validations
- Audits
- Documentation
- Vendor / Supplier
- Validation
- Facilities
- cGLP / cGMP / QSR
- Process
- Warehouse
- Part 11 - Gap analysis
- DEA Auditing
- Cal-OSHA
- Fed-OSHA
- Proposition 65
- EPA
Development & Product Transfer- Characterize processes / formulations
- Develop methods, equipment and systems
- Simplify processes (downstream / upstream)
- Product Transfer R&D to Manufacturing
- Product / Process Xfer - Facility
- Reduce Failure rate
- Business Strategy Evaluation
- Factory Acceptance Testing / Site Acceptance Testing (FAT / SAT)
Environmental Monitoring- PM count
- RODAC™ sampling
- Surface Swabbing
- RCS Sampling
- Water PM / Bioburden
- Product Bioburden
Reference Accounts- Work Detail Performed for previous clients
- Baxter BioScience
- Intralase Corporation
- LG LifeScience - Korea
- Mills BioScience Inc. / Urocor - OKC, Oklahoma
- Roche / Oread - Palo Alto, CA
- Qualisys Diagnostics Inc.
- McGaw / B.Braun
- Allergan
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| | | | | | | | | | | Why choose me over the others?What sets me apart from others: I work mostly independently and have very little overhead. Only when necessary, I utilize experts from my network who hold supreme expertise in their field (e.g. Certified Industrial Hygienist, ex-FDA agents, etc.) I make sure that my client is fully satisfied even if that means working even harder. I am incorporated so I can work 1099 or W9 (corp-to-corp). I research subject matter thoroughly and am up-to-date with regulatory and technical positions. I have repeat clients since the beginning of my consulting career. I am hardworking and assertive, delivering the highest quality work with respect to thoroughness and deadlines. I am innovative and creative in my approach and have pharma / medical device experience since 1995. I do not price gouge. My rates are much lower and tailored towards low to mid level budgets.
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