Expert Details

Expert in Regulatory Affairs, Technology Management, Pharmaceutical Industry, Turnaround Management

Expert ID: 725858 India

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Expert has experience in applying 21 CFR Part 11 to the manufacturing of pharmaceuticals and preparing and facing FDA inspections. He has more than 20 years of experience in various facets of API industry ranging from research to manufacturing, projects, regulatory affairs, quality assurance / process control, general management. He has studied applied organic chemistry at Post graduate and doctorate level and came out with flying colors. He has hands on experience in Aseptic pharmaceutical Process Validation for Sterile Cephalosporins (APIs). He has experience in bulk packing of generics and APIs which involves use of bulk packing materials. He has experience in bulk packing of generics and APIs which involves use of bulk packing materials. He successfully handled contract manufacturing at major strategic partners during his association with Actavis / Alpharma and Kopran.

He has successfully applied cGMP during his tenure at Ipca, Ranbaxy, Kopran, Actavis / Alpharma, and plant got approved by various regulatory agencies. He has got experience in the development of various APIs and Dosage forms. He worked with world's top ten generic company and worked on the end to end development of generic drugs ranging from API development, API manufacturing, DMF filing, Dosage form Development, bio batches, ANDA filing, commercial production and product launch. He has worked on the synthesis of heterocyclic compounds during Ph.D. He has hands on experience in nonaseptic process validation during his employment and association with various companies. Organic chemistry was his specialization during M.Sc. and Ph.D. and worked in industries who are involved in manufacturing or organic compounds. He helped the alliance partner in preparing for PAI and company got approved without any 483. Presently assisting the client for PAI.

He provided regulatory consultancy to one of the client for the preparation of US FDA Pre Approval Inspection. This is an extensive green field project which includes creation of Quality Management System, helping the client in compilation of Dossier, Process Validation, and Cleaning Validation and conducting mock PAI.He audited API manufacturing facility to ascertain client's preparation for inspection and suggested the ways to correct the gaps.

Education

Year Degree Subject Institution
Year: 1982 Degree: Ph.D Subject: Synthetic Organic Chemistry Institution: National Chemical Laboratory, Pune, India
Year: 1978 Degree: M.Sc. Subject: Organic Chemistry (Drugs) Institution: Vikram University, Ujjain, India
Year: 1976 Degree: B.Sc. Subject: Chemistry, Botany, Zoology Institution: Vikram University, Ujjain, India
Year: 1987 Degree: P.G.Diploma in Production Management Subject: Production management, marketing, finance mgt. Institution: Marathwada Univerity, Aurangabad, India

Work History

Years Employer Title Department Responsibilities
Years: 2008 to Present Employer: Undisclosed Title: Associate Department: Regulatory Affairs Responsibilities: He works with clients in the pharmaceutical industries to develop quality assurance and regulatory strategies for compliance with US FDA and European regulations by:

• Conducting assessments of client studies, procedures, and programs to determine compliance.
• Development and adherence to Quality Systems;
• Development and control of various documents.
• GMP for process and facility;
• Validation with respect to,
-Validation Master Plan (VMP) drafting, incl.facilities, utilities, equipments, process &
analytical methods;
-Generating of validation protocols and reports;
- Validation training;
- Execution of DQ, IQ, OQ & PQs ;
• cGMP and GLP compliance with .respect to,
- Auditing (self-inspections and suppliers);
- Preparing for inspections and pre-approval inspections;
- Sterile and aseptic production techniques;
- Documentation control and support and Standard Operating Procedures (SOPs).
Years: 2005 to 2007 Employer: Actavis Group / Alpharma Inc. Title: Technical Director (Asia) Department: Alliance Management Responsibilities: He managed Human Pharmaceuticals Div. development programs and initiatives including product Research & Development, Technical Services organization projects, Business Development due diligence support and Scientific Affairs Regulatory Compliance activities performed through one or more partner companies in the Asian Sector.
• He proactively managed cross-functional teams between parent and partner organizations to include the areas of Research & Development, Technical Services, Manufacturing, Operations, Quality, Regulatory, Marketing, Intellectual Property and Legal to ensure that Scientific Affairs objectives including completing ANDA and MA filings and launching new products are achieved in a timely and GMP compliant manner.
• He proactively managed cross-functional teams of technical and non-technical personnel to assure efficient technical transfer of new products/processes to commercial operations and to prepare the organization for FDA and European regulatory authority pre-approval inspection (PAI) audits.
Years: 2000 to 2005 Employer: Kopran Limited, Mumbai, India Title: Vice President - Technical Department: Profit center -API Responsibilities: - He functioned as a change agent in evaluating all operations, developing / implementing sound manufacturing strategies to optimize resources and equipments while ensuring product quality and timely delivery.
- He defined and recommended mfg. objectives, develop specific short-term and long-range plans and program together with supporting budget requests and financial estimates.
- He continually and aggressively reduced the business unit’s cost position. He optimized production while driving efficiency.
- He identified and prioritized opportunities to improve overall gross margins.
- He directed, reviewed and approved the development of objectives, policies and programs for operations activities involving sourcing, supply chain mgt., quality, manufacturing, mfg, engineering, projects, regulatory affairs and process development.
- He provided leadership on production-related procurement by developing strategies and objectives along with the strategic sourcing team to identify and develop high-quality, low-cost suppliers on a worldwide basis.
- He was actively involved in promoting key strategic alliance partnerships, new business development, joint ventures and technology transfers at an international level.
Years: 1996 to 1999 Employer: Ranbaxy Laboratories Limited, Dewas, India Title: General Manager - Manufacturing Department: Unit Head -API Responsibilities: His overall responsibility was for API manufacturing at site.
Years: 1993 to 1995 Employer: Ipca Laboratories Ltd., Indore, India Title: General Manager Department: Profit centre- API Responsibilities: He had multi locational responsibility manufacturing API and APIs intermediates.
Years: 1990 to 1993 Employer: Stellar Chemical Laboratory, Derol, India Title: Works Manager Department: Profit Center - API Responsibilities: He set up R & D Center, Pilot Plant and commercial plant and managing commercial production of APIs.
Years: 1989 to 1990 Employer: Jayant Vitamins Ltd., Ratlam, India Title: Manager - Process Control Department: Process Control / R & D Responsibilities: He managed the Process Control and R & D departments
Years: 1988 to 1989 Employer: Nicholas Laboratories India Ltd., Mumbai, india Title: Manager - Bulk Drugs Department: API Responsibilities: He set up API division which includes setting up of R & D Center, pilot plant and commercial plant for the manufacture of APIs.

Career Accomplishments

Associations / Societies
He is a Member, Indian Institute of Management, Ahmedabad and Administrative Staff College of India Alumni Association.
Professional Appointments
He has been: Secretary, Chemical Association during M.Sc. and Secretary, Student Union during B.Sc.
Awards / Recognition
• Significant Performance Award by Wockhardt and helped the company in winning Award for R & D Efforts in Industry of Govt. of India.
• Merit and National Scholarships, Junior & Senior Research Fellowship of CSIR., Govt. Of India
• N.C.C. ‘B’ Certificate.
Publications and Patents Summary
He published three papers in international and national journals during Ph.D and published one Us and one India patent.

Additional Experience

Training / Seminars
He delivered various seminars and imparted training to employees at Ipca Labs, Ranbaxy Labs, Actavis partner companies and Marion Weinreb & Associates clients on the following
? GMP Basics
? Regulatory compliance
? In- house Seminars.
? Training Modules preparation
Vendor Selection
He has hands on experieence in developing strategic alliance partnerships, auditing various facilities for future tie-ups, auditing Clinical Research Organizations and Research Centers, technical due deligence.
Developed long term contracts for supply of key raw materials
Marketing Experience
He has expertise in various facets of Pharmaceutical industry ranging from general mgt, Operations, R & D, projects, process control, regulatory affairs, business development & partnership management.Areas of expertise include the following:
MANUFACTURING / OPERATIONS
? Cost Reduction – Quickly analyze variable and fixed operating
costs and reduce spend
? Restructuring/turnaround management – Optimize operations,
consolidate, outsource and reduce costs
? Performance Improvement – Lean efficiency transformations, best
practices, employee involvement and sustainable results
? Interim Management – Immediately step into a key
operations or manufacturing role and hit the ground running,
provide expertise, leadership, teamwork and stability
? Improving capacity & through-put
? Multi location operations.
? Team building
? Handling of cross-functional teams
? Manufacturing of Sterile API

PROJECTS
? End-to End Development Projects
? Facility Designs
? Partnership Management
? Capacity expansion
? Quality & Research Laboratory Design
? Quality & Research Laboratory Design
? Improving capacity & through-put

REGULATORY COMPLIANCE

? Quality System Development & Implementation
? Internal GMP Audits
? SOP Preparation
? Analytical Laboratory Audit
? Audit of CROs (Clinical).
? Audit of Vendors / Suppliers
? Audit of Research Laboratories

PROCESS DEVELOPMENT

? Process Start-ups, Scale-Up & Commercialization
? Process Optimization
? Process Reengineering
? CMC Documentation
? Technology Transfer

VALIDATION

? Preparation of Validation Protocols & Master Plans
? Protocol Implementation
? IQ, OQ and PQ of Systems
? Process Validation
? Cleaning Validation
? Analytical Methods Validation
? Utility Validation
Other Relevant Experience
He is a turnaround expert in pharmaceutical industry specifically API industry.

Language Skills

Language Proficiency
German
English very profiecient
Gujarati
Marathi

Fields of Expertise

21 CFR Part 11, Food and Drug Administration regulation, active pharmaceutical ingredient, bulk drug, bulk pharmaceutical chemical manufacturing, contract manufacturing, bulk packaging material, aseptic pharmaceutical process validation, applied organic chemistry, Current Good Manufacturing Practice, Food and Drug Administration compliance, Good Manufacturing Practice, drug development, generic drug, generic drug manufacturing, heterocyclic compound synthesis, nonaseptic pharmaceutical process validation, organic chemistry, synthetic organic chemistry, pre-approval inspection, chiral synthesis, pharmaceutical technology, antidepressant drug, calcium alginate, drug product approval, organic chemical separation, pharmaceutical manufacturer, drug formulation, pharmaceutical research and development, pharmaceutical manufacturing facility auditing, drug processing, pharmaceutical product shelf life testing, pharmaceutical capsule, organic compound process development, tablet manufacturing, pharmaceutical quality assurance, Food and Drug Administration CFR-21 part 175, organic reaction, drug stability, addition reaction, pharmaceutical industry, pharmaceutical engineering, pharmaceutical analysis, pharmaceutical quality control, antihypertensive drug, drug regulation, organic compound, pharmaceutical reactor, pharmaceutical chemistry, organic synthesis, organic chemical structure, injectable drug, Good Laboratory Practice, drug screening, dosage form, chemical analysis, anticonvulsant drug, anti-inflammatory drug

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