Skills

MY BACKGROUND: Senior Professional having extensive experience in Regulatory and Quality Management Systems.  Certified auditor to conduct audit as a lead auditor.

MY SPECIALIZATION:

• ISO 9001:2015, ISO 13485:2016, ISO 14971, ISO 22716, ISO 31000
• USFDA 21CFR Part 4, 111,210,211,700,701,740,820
• 21CFR part 11, GAMP 5, EU Annex 11
• EU GMP
• ICH Q7, Q9, Q10
• PIC/S

WHAT I CAN DELIVER:

• Consulting and support to get ISO approval
• Develop Quality management System
• Risk management
• Regulatory Support
• Feasibility study
• Site Master File as per PIC/S Guideline and Site Validation Master Plan
• Risk based Facility, Utility, Equipment Qualification
• Computer System Validation
• Risk Based Process Validation, Cleaning Validation
• Transport Validation
• SOP preparation, Gap Analysis of cGMP and define action plan
• Training material/plan/report
• Manage Audit as a “Certified Auditor”
• Project Management / Coordination with Clients, Subcontractors and Suppliers
• Preparation of manufacturing and Quality Agreement

Refrences

KEY PROJECTS:
? Sterile facility renovation: Risk Assessment, Gap Analysis and Qualification
? Achieved accreditation of PIC/S GMP certificate for Sterile manufacturing facilities: Preparation and submission of CTD Dossier, Management of Audit conducted by PIC/S authority
? Implementation of New Cleaning Validation concept:
? by matrix approach in terms of maximum-minimum lethal dose, therapeutic dose, cleanability and solubility profile recommended by pharmacopoeia.
? 10ppm, therapeutic dose and PDE criteria
? PDE determination for OEB 1,2, 3 as per EMA Guideline.
? Define Training package and procedure for new/existing/job rotation/long absence
? CAPA tracking

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