MEDATEQ LABS team of pharma professionals rationally design quality management systems and help to implement through trainings. Our experts perform third party evaluation and gap analysis with a quantified tool to assess the company’s state of regulatory compliance. We help the companies in designing CAPA for deficiencies raised by regulatory inspections. An online and offline monitoring of QMS at site is performed by our experts through quality matrices. This tool is significantly helpful for pharma companies to remain in state of compliance and all time ready for regulatory inspections. Pharma technology solutions and compliance consulting services in India. It covers different categories of pharmaceutical manufacturers: Formulations, APIs, Sterile/Injectable and Ayurvedic/ Phytopharmaceutical products.

Experts in MEDATEQ LABS are qualified trainers on cGMP and Pharmaceutical Quality Management Systems. We conduct trainings and workshops on current focus areas of regulators such as Data Integrity, OOS Root Cause analysis and CAPA, Quality Matrices, QbD, Handling of regulatory audits and Certification of internal Auditors. The key conditions, required actions, and responsibilities for implementing the Revised Schedule M as per CDSCO and MoHFW guidelines.

Training modules as per the customer specific requirements in RA, QA, cGMP, GLP, GCP, ISO, 21 CFR parts, Audits, Validations and many more topics.
Upgrading the GMP standards of the existing plant, without much of additional investment.
Evaluation of supervisory staff and managers after training.
Personal Behavior in Clean areas
COST Improvement Projects

Trainings & Workshops

Pharmaceuticals Manufacturing Support
Technology Transfer
Standard Operating Procedures – QA/QC/Manufacturing/Maintenance/ GMP Environment.
QMS (Deviation, Change Control, Out of Specification, out of trend, market complaint & Product Recall Root Cause Analysis, CAPA)
Schedule –M
GMP and Compliance
GMP Auditor Training for Quality Systems.
GMP requirement for pharmaceutical facilities, Warehouse, Utilities & Quality control.
cGMP in-line with ICHQ7
WHO guidelines & WHO-TRS 986
Site Master File
Quality Manual
Quality Policy
Validation Master Plan
Risk Management as per ICH Q9
Internal Audit/Self Inspections
Data Integrity
Job Trainings
Training of Trainers
Validations (Process Validation, Analytical Method Validation, Installation Qualification, Operational Qualification Method Validation, Facility Qualification, Purified Water validation, Transferring Skill on Validation, Computer System Validation)
Qualification
Calibration Procedures and Maintaining Records
Chromatography and its Applications in Pharmaceutical Analysis
Clean Room Operations, Equipment Handling and Documentation Activities