Qdot Associates endeavor's to implement its collective experience and expertise spanning over four decades to deliver 'sustainable improvements' by moving beyond services and deliverables through the principles of 'design for compliance. This endeavor is achieved through a holistic life cycle approach for the systems, integrating the processes and aligning the personnel, leading to a desirable state of 'compliance by design.
Services:
Remediation:
• Audit observation
• US FDA Form 483
• Warning Letter
• Audit Response
• Import Alert
• Product Recall
Investigations:
• Root Cause Investigation / Root Cause Analysis
• Hypothesis
• Interview
• Immediate Correction
• Corrective Action Preventive Action
• Trending
• Effectiveness
• Complaints
• Deviations
Data Integrity
• ALCOA / ALCOA++
• Attributable - Legible - Contemporaneous - Original - Accurate - Complete - Consistent - Enduring - Available
• Data Reliability
Training
• Analyst Qualification
• Technical Training
• cGMP Training
• Competency Assessment / Building
Automation
• Training / Learning Management System
• Sample Management system
• Backup and Archival Management System
• Validation & Qualifications
• Equipment / Instrument Qualification
• Calibration
• GAMP
• Computer System Validation
QbD
• Control Strategy
• Quality Risk Management
• QTPP (Quality Target Product Profile)
• CQA (Critical Quality Assurance)
• CMA (Critical Material Attributes)
• CPP (Critical Process Parameters)
• Process Development Report
• Product Development
• Method Development
• Analytical Target Profile
• Established Conditions
• Design of Experiments
• Process robustness
Due Diligence (Systems, Facilities, Products)
• Pharmacopoeia
• Risk-based approach
• Gap Assessment
Company Details
- Employees
- 9
- Founded
- -
- Address
- Plot No. 181/1,, Hi-Rise Meadows,mallampet,near Bachupally,india
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- http://www.qdotassociates.com
- HQ
- Hyderabad, Telangana
Qdot Associates Questions
Qdot Associates's website is http://www.qdotassociates.com
Qdot Associates's LinkedIn profile is https://in.linkedin.com/company/qdotassociates
Qdot Associates has
9 employees.
View email and phone details for 9
employees at Qdot Associates.
Qdot Associates's industry is
Pharmaceutical Manufacturing
Qdot Associates's top competitors are
Kaizen Technologies,
8chili Inc,
100 Buddies,
Devpac Group,
Amneal Pharmaceuticals,
Avanteva Solutions (Opc) Pvt. Ltd,
Ritchietech,
Yosnapps,
Ebridge Solutions,
Aegis Smart Logix.
Qdot Associates's categories are Pharmaceutical Manufacturing
Qdot Associates's founding year is 2018
