Qualification
M.Sc. and Ph.D. in Microbiology from University of Pune, India

Professional Expertise – International Trainer, International Auditor and Consultant

Guidance to pharmaceutical professionals/organizations on current GMPs, sterile GMPs, GLPs, Validations, Microbiological Practices, Aseptic processing, process simulation/media fill study, 21 CFR Part 11 and GAMP.

Regulatory submissions of all types: For Drug Products and APIs to different regulatory agencies globally and close interaction with these agencies (Prepared 126 DMFs, 1 IND, 98 ANDAs, 59 EU Marketing Authorization Applications).

Regulatory Approvals: Consultancy provided to several companies in obtaining approvals / certifications from various regulatory agencies (42 US-FDA approvals, 27 MHRA certifications, 29 TGA certifications, 34 EDQM certifications, 11 WHO-Geneva certifications, 11 ANVISA approvals and 7 MCC S. Africa certifications).

International Auditor for R&D and Manufacturing facilities (Facilities inspected till-date: 85 APIs, 123 Dosage Forms, 17 Biopharmaceuticals, 6 Medical devices and 165 QC Laboratories (which include Chemical, Microbiological and Clinical Labs). Reviewed 143 ANDAs, 112 US + COS DMFs, 33 EU MAA Submissions, 6 BLAs of client companies.

International Trainer on cGMPs, GLPs, Validations, Regulatory, Microbiology, Aseptic processing, ICH processes, US & European guidelines, manufacturing & Laboratory technologies. Conducted more than 7100 seminars till-date.

Facility, Laboratory design and Layout : GMP and GAMP requirements for designing facilities and equipment. Successfully designed, commissioned, qualified facilities (39 oral solid dosage facilities, 53 aseptic processing injection facilities, 17 aseptic lyophilization facilities, 8 hormones facilities, 6 vaccines facilities, 67API facilities, 4 medical devices facilities, 6 oncology facilities, 3 steroids facilities).

Lyophilization technology.

Summary of Professional Experience
Started my career as a teacher at the Government Institute of Science, Aurangabad teaching Microbial Genetics and Microbial Biochemistry from August 1977 – January 1984.

Associate Professor - Microbiology.
Special area of interest
Biodegradation of hydrocarbons
Geo-microbiological extraction of minerals (bio-leaching)
Published 11 scientific papers from original research on biodegradation of hydrocarbons and 12 on bio-leaching.

Served in ARISTO Pharmaceuticals Ltd., as QA Manager in its dosage form facility at Aurangabad, India (January 1984 – July 1991).
Special achievement was the Analytical Development and GMP designing of ARISTO’s injectable facilities.

Served in Ranbaxy Laboratories Ltd., in its new Cephalosporin’s facility at Mohali, Punjab, India as QA Manager (July 1991 – March 1996). Served in QC and QA and then in Documentation function (preparing Regulatory dossiers)

Served as Divisional Manager – Regulatory Affairs & Documentation (June 1993 – Dec 1994)

Served as Divisional Manager – GMPs and Training (Dec 1994 – March 1996)

As General Manager – Systems & Documentation (April 1996 – Dec 2000) was responsible for establishing Systems and Documentation, Validations and Regulatory Compliance in Ranbaxy.
Assisted in preparation of Regulatory dossiers and their evaluation.
Responsible for training the organization to constantly remain in “state of preparedness” for inspections.
Served as Lead Escort in several US-FDA, MCA-UK (now MHRA), TGA-Australia and other Regulatory Inspections from 1996 onwards for all manufacturing sites, and were successful in getting approvals.

Served as General Manager – Quality Affairs & GMP Training (January 2001 – February 2002)
Responsible for Quality Control and Quality Assurance functions in all manufacturing facilities and also GMP Training in all manufacturing facilities and R&D.
Responsible for the Regulatory compliance and audits for GMP compliance in all manufacturing facilities

Joined ORCHID Chemicals & Pharmaceuticals Ltd., Chennai, India as Vice President – Regulatory Affairs and Quality Affairs in March 2002

Responsible for global Regulatory Submissions for APIs, Dosage Forms, IND documentation and to ensure success during Regulatory inspections by reinforcing Learning and improving the systems and practices.
Served as Lead Escort in Orchid’s USFDA, EDQM, MHRA and TGA inspections, for all manufacturing facilities, and successful in getting approvals.
Guiding the New Drug Discovery Research (R&D) in its documentation systems, procedures and practices to prepare for GLPs and IND applications.
Guided in Technology Transfer, GAMP validations, software validations, etc.

Last position held was President – Corporate Regulatory Affairs and Quality Affairs (March 2004 – June 2006

Conferences, Seminars & Workshops :

Participated in a number of International pharmaceutical conferences and workshops related to – Validations, cGMPs, Regulatory and Compliance.

Delivered more than 7600 seminars and lectures on subjects related to cGMPs, Regulatory, Validations, Documentation, Microbiology and QC-QA in India and abroad.

Professional Memberships :

Parenteral Drug Association (PDA), Bethesda, USA, since 1997;
Institute of Validation Technology (IVT), USA since 1997;
American Society for Quality (ASQ), Wisconsin, USA since 1996
Regulatory Affairs Professional Society (RAPS) USA since 1997;
International Society of Pharmaceutical Engineering (ISPE), Florida, USA, since 1997
Institute of Environmental Sciences and Technology (IEST), Illinois, USA since 1997.

Professional Contributions :

Contributed to the understanding of aseptic processing in pharmaceutical industry.
Contributed to the understanding of the Validation requirements in the pharmaceutical industry.
Contributed to the understanding of the Media Fill and Process Simulation of the aseptic processing in the pharmaceutical industry.
Contributed to the introduction of special microbiological techniques in the pharmaceutical industry.

Conferences Organized :

1. Microbiology in Support of Pharmaceutical Manufacturing – Beyond the Obvious (November 2004, Chennai)
2. Surviving Challenges of Validations in Aseptic Processing and Sterilizations (May 2005, Mumbai)
3. Technology Transfer – Conceptualization to Commercialization (July 2005, New Delhi)
4. Laboratory Controls & Laboratory Compliance – A Game-plan (February 2006, Mumbai)
5. Workshop on" Validation Week” (October 2006, Chandigarh)
6. Microbiology in Support of Pharmaceutical Manufacturing – Beyond the Obvious Part II (October 2006, Mumbai)
7. Indo-Europe API Forum – Basel, Switzerland (November 2006, Basel)
8. New Challenges in Regulatory Submissions – US & EU Scenarios (December 2006, Indore).
9. Workshop on “Good Documentation Practices” (January 2007, Dehradun)
10. Workshop on “Aseptic Processing – Assuring Sterility” (February 2007, Pune)
11. “Latest Technologies – HVAC & Water Systems” (March 2007, Amman, Jordan)
12. “Latest Technologies – Water for Pharmaceutical Use” (March 2007, Hyderabad)
13. “Surviving Challenges of Regulatory Inspection – Achieving Success” (April 2007, Ahmedabad)
14. “Microbiological Practices in the Pharmaceutical Industry” (June 2007, Dehradun)
15. Conference on “Laboratory Control & Laboratory Compliance – A Game plan to Success (September 2007, Chennai).
16. 5-day Conference cum workshop: Validation week ( June, 2008 - Chandigarh)
17. 17. Conference on Aseptic Processing and Regulatory Documentation (August, 2008- Goa)
18. 18. Training workshop on Competency development in GMPs & Regulatory Compliance (April, 2009- Pune)
19. Conference on Current Trends in Aseptic Processing – A risk based approach (June,2009- Indore)
20. Workshop on Good Engineering Practices (November, 2009 – Hyderabad)
21. Workshop on "Handling Deviations and CAPA” (November, 2009 – Dehradun)
22. Workshop on "Validation Week” (February 2010 – Aurangabad)
23. Process Validation & Product Quality Review (March, 2010 – Chandigarh)
24. Training Program on “Current Trends in Stability Studies” (March, 2010 – Dehradun)
25. Three-day Training Program on “GMP – GDP for QC-QA personnel” for Aurobindo (April 2010 – Hyderabad).
26. Training workshop on “Competency development in GMPs & Regulatory Compliance” (May, 2010 - Hyderabad).
27. Training Program on “Handling Deviations and Leveraging CAPA” (May, 2011 – Panchkula).
28. Training Program on “New GMP Initiatives” (May 2011 – Navi Mumbai).
29. Training Program on “Basic GMPs in Vaccines Manufacturing” (September 2011 – Pune).
30. Training Program on “Utilization of Statistical tools in Process Control” (November 2011 – Chennai).
31. Training Program on "Handling Deviations and CAPA” (January 2012 – Amsterdam )
32. Training Program on “Quality by Design and Regulatory Perspective” (February 2012 – Bangalore).
33. Training Program on “Execution and Packaging of Exhibit batches” (May 2012 – Mumbai).
34. Training Program on “Sterilization processes and Validation concepts” (August 2012 – New Delhi).
35. Training Program on “Competency development in GMPs & Regulatory Compliance” (September 2012 – Singapore).
36. Training workshop on “Good Documentation Practices” (October, 2012 - Hyderabad).
37. Training workshop on “Challenges of Compiling a Regulatory Dossier “ (December 3 – 4, 2012, Brussels).
38. Training Program on “Developing, Processing, Packaging Controls - Regulatory Perspective” (December 17 – 18, 2012, Pune).
39. One year Training project on “Quality – Culture of Compliance” in Ranbaxy, Dewas Indore (January 2013 – January 2014).
40. Two-day Workshop on Statistical Applications in Pharmaceutical Manufacturing (March 2013 – Singapore).
41. Three-day Workshop on “Train-the-Trainers for GMPs” for Wockhardt (November 2013 - Aurangabad)
42. Three-day Training Program on “Good Engineering Practices – Regulatory Expectations” for Wockhardt (December 2013 - Aurangabad)
43. Three-day Training Program on “Good Engineering Practices – Regulatory Expectations” for Wockhardt (February 2014 - Aurangabad)
44. Two-day Training Program on “Wisdom of Compliance Through ICH Q10” (February 2014 – Singapore).
45. Three-day Training Program on “GMP – GDP for QC-QA personnel” for Ranbaxy (June 1st week, 2014 – Mohali).
46. Three-day Training Program on “GMP – GDP for QC-QA personnel” for Ranbaxy (June 4th week, 2014 – Mohali).
47. Three-day Training Program on “GMP – GDP for QC-QA personnel” for Ranbaxy (August 2014 – Toansa).
48. Two-day Workshop on “Avoiding Data Integrity and Reliability Issues” (October 9-10, 2014 – Indore)
49. 51. Two-day Training Seminar on “Aseptic processing of sterile APIs” (November 20-21, 2014 – Mumbai).
50. Three-day Workshop on “Training the Auditors for GMPs” (December 5-6, 2014 - Pune).
51. Two-day Workshop on “ Compliance through Competence” (January 9-10, 2015).
52. One-day Seminar on “Quality by Design” in Nectar Lifesciences, Chandigarh (January 16, 2015).
53. Two-day Training Workshop on “Stability Studies” in Nektar Therpeutics, Hyderabad (August 7-8, 2015).
54. One-day Seminar on “Current Regulatory Challenges” in Hotel Taj West End, Bangalore (August 25, 2015).

GMP Pharma Institute Private Limited (abbreviated brand name PIGMP)
(Formerly: Pharma Institute of GMPs)

This is an independent organization founded by me to provide following services to the pharmaceutical industry and allied industry:

Training:
Organizing seminars, workshops, conferences for the pharmaceutical professionals on special areas – related to GMPs, GLPs, Technology Transfer, Analytical methods development & validation, Aseptic processing, Validations, Regulatory Guidelines, Regulatory Submissions & Inspections, Process Development, Bio-pharmaceutics, Clinical research, etc..
To help create awareness and competency.

Consultancy Services related to:

Facility designing,
Facility Qualifications, process validations, all other types of validations,
Development of SOPs, systems & documentation,
Regulatory submissions & responses,
Technology Transfer,
Cross contamination related,
Microbiology & Contamination related.

Auditing Services of:
API facilities, Pharmaceutical facilities, Injection facilities, Biotechnology facilities, biopharmaceutical facilities, R&D facilities, QC laboratory facilities and medical devices facilities.

GMP & Regulatory solution providers:
This service includes providing solutions to tricky problems encountered by companies related to GMPs, Contamination and Regulatory.