AN ISO 9001:2015 CERTIFIED
Company Connect Consultancy: Your Partner in Pharmaceutical Audit Excellence
Navigating the complexities of pharmaceutical audits with expertise and precision.
Our Auditing Team
•39+ years of Progressive experience, in areas of Quality Assurance in the Pharmaceutical (Solid Oral GeneralTablets , Effervescent Tablets and Sachets, Lozenges, Liquid, Parenteral ) and API industry.
•Champion for Total Quality Management(TQM) and had been on Leadership position in Top Pharma COS for about two decades
•Proven successful track record of Quality Assurance and GLP in Quality Controls Laboratories in pharmaceutical industry with strong focus on Regulatory compliance's , Social Audit Compliance as per WalMart ,CVS requirements , Liaisons with regulatory bodies audits.
•Consistent contributor to implementing "Best Practices" in global working environment, which supports harmonization and growth to organization.
•Strategic thinker & pragmatic problem solver. Has a keen insight and understanding of US ,EU, cGMP requirements.
• Thorough exposure of multicultural, multinational ,challenging environment and excellent communication skills for dealing at all levels – unskilled workmen to senior employees within the organization.
•US -FDA -At Vovantis Laboratories Private Limited as Team Leader Get Approval and At Ipca Laboratories Limited for API– 2 times•TGA & MHRA –at J.B.Chemicals and Pharmaceuticals (JBCPL) -Unique Group-2 times.
•WHO- Geneva At Ipca Laboratories Limited for API & Pharma -2 times.
•MOH of Kenya, Ivory Cost ,Congo ,Sierra Leone, Uganda,Ghana, Yemen, Cameroon- more than 2 times•WHO India at Ipca, JBCPL ,Vovantis almost 7 times
●Social Audit :
●GMP Audit For Overseas Customer :•Intertek,UL and NSF GMP for CVS , Walmart , Walgreen ,Target. (overseas customer) - Get Certification and keep maintained more than 4 year.
• For CVS ,Walmart , Walgreen and Target (overseas customer) conducted by Intertek, UL Lab - successfully qualified and keep maintained more than 4 year.•Working as Neutral Auditor for Overseas Customer for Indian Supplier for Drug Products /Drug Substance(API)
●cGMP Documentation & Training For Quality System Implementation- Projects (Completed /Under Progress) For Regulatory compliance
• Train The Trainers
• Quality Management System
• Quality Risk Management
• Investigation Skills
• Stability Management
• Technology Transfer
• CAPA
• Quality by Design
• Trending and Data analysis,
• Technology Transfer,
• Strategist for quality compliance,
• Facility -Audit ,Gap Analysis , Design of Facility as per requirement Of Regulatory
• Qualification,
• Harmonization and simplification of best practices• Waste Elimination
• On Job Training To Workmen to Management Staff.*As a consultant in last five at different Organization remain Observer for USFDA ,Yemen MOH , NAFDAC ,WHO-India during Regulatory Audits ,Customers Audits and compliance prepared ,implemented ,Get Organization Approved from the Authorities. Gap Analysis for Plant Design and New section creation .
Comprehensive Audit Solutions
Audit Readiness Assessments
Pre-audit gap analysis and risk assessment using a 250-point checklist based on CFR Parts 210, 211.
Mock Audits
Simulated regulatory audits conducted by former FDA/EMA inspectors to identify vulnerabilities.
Audit Remediation
Development and implementation of CAPA plans to address audit findings and reduce remediation timelines.
Training Programs
Customized GMP, GLP, and GCP training programs for all personnel levels, enhancing knowledge retention.
Industry Expertise: Connecting Across Sectors
Biopharmaceutical Manufacturers
Assistance with GMP compliance for biologics production and regulatory adherence.
Generic Drug Manufacturers
Guidance on ANDA submissions and ensuring compliance with FDA regulations.
Contract Manufacturing Organizations (CMOs)
Support with supplier audits and compliance with stringent client requirements.