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• 21 CFR 820 QSR for Medical Devices
• 21 CFR Part 210 & 211
• Auditing Knowledge Bank
• CDER ICH Q7A Guidance
• Drugs & Cosmetics Act India
• GMP Schedule M
• Good Audit Practices
• ISO 14001 Audit Checklist Word Document
• NABL Publications

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Products and Services Offered

First Party, Second Party and Third Party Audits ofManagement Systems for

1. QMS ISO 9001: 2008
2. UNI 10854: 1999
3. QMS ISO 13485: 2003, 93/42/EEC (MDD), 98/79/EC (IVD),CE Mark
4. EMS ISO 14001: 2004
5. GLP ISO 17025: 2005
6. FSMS ISO 22000: 2005
7. ICH Q7A, 21 CFR 210, 21 CFR 211, 21 CFR 820, 21 CFR 11
8. cGMP, Product and Process Audits for Food, Drug and Cosmetics
9. Risk Management and Analysis, OHS Assessment
10. EFfCI GMP Guide 2008 - The European Federation for Cosmetic Ingredients
11. Implementing Contamination Prevention, ECPA ed. 2 English (2008) - European Crop Protection Association (ECPA) and CropLife International

Visit for more information: http://www.irca.org/,http://www.iso.ch/, http://www.qcin.org/

Send your feedback and comments by Email on:pravingothe@gmail.com
Available for Private Work covering : -

1. Documentation for QMS/EMS/FSMS/CE/cGMP/WHO
2. Internal Auditors Training
3. Training and Development for Managment Systems
4. Lead Auditors Training
5. Documentation for Laboratory Accreditation
6. Second Party (Global Customer) Audits

Contact on: pravingothe@gmail.com

Audit Experience (1996 to till date....)

Audited more than 1200 organizations for ISO 9001 / 13485 / 14001 / 22000 / OHSAS 18001 / GMP / 21 CFR 210 / ICH Q7A till date including: -

1. API - Alchymars (AIS), ACI (Bangladesh), Aptuit Laurus, Divis, Dr Reddy's Lab, Jubilant, Innovasynth, Cadilla, Smruthi Organics, Sun, Gulbrandsen, Neuland Lab,
2. Animal feed - Sabar, Amul, Sumul, Sundara Agro
3. Beverages - Bombay Breweries, Champagne Indage, Parle, Marico
4. Biologicals - BASF, Phoenix, Syngenta, Sumitomo Chemicals
5. Cargo - GATI, A-1,
6. Cement - C. Raghoji, Ambuja BCT
7. Ceramics - SunEarth, H&R Johnson
8. Chemicals - BASF, DNL, Sunshield, Mitsu, Bilag, Tata Chemicals, Fine Organics, Balaji Amines, XPRO, Varda Biotech, Syngenta, GAIL, RCF, Laffans, HPCL, Sadhana Nitrochem, Sekhsaria, Rolex, IOGPT, Monarch, Colourtex Group, Thomas Baker, SC Enviro Agro,
9. Clinical Research Organizations (CRO) - SIRO Clinpharm
10. Confectionary - Cadbury's, Parle, Amul Chocolates at Mogar
11. Cosmetics - Gulbrandsen, Godrej, Royal Castor Products
12. Dyes - Zenith Intermediates,
13. Dairy Products - Baroda, Gokul, Kheda, Madhur, Mother, Panch Mahal, Sabar, Sagar, Sumul, Vasudhara, Uttam, Saurash
14. Education - Bright Schools, DAV Schools, CCDC at IES College, Dr. BS Konkan Krishi Vidyapeeth at Dapoli
15. Electricals - KC Fixtures, FCG, Govan, Intek IRD, Cona, Keystone, Situ, Axis, Paramount, Torsion, Meta Clad,
16. Electroplating - Progressive Electroplating
17. Foods - Multania Bread, Ruchi Soya, Priya, Temptation, Taj Fresh, Ekta, Madhav, HLL, Sona, CavinKare
18. Food Chemicals - Royal Castor, RPG Life Science, Everest, TabCoat, Selective, Rhodea, AIMCO,
19. Food Edible Oils - Bunge at Trichy, Liberty Oil Mills, Ruchi Soya,
20. Food Packaging - Essel, IPN, Kaira Can, Arrow, FLoeter India
21. Heavy Enginering - Carriage Workshop, Ajmer, Richardson & Cruddas, Govan, Indian Valves, NDMB C. No. 33,
22. Healthcare Specialities - ARF - Rotunda, ReGenesis, Sperm Processor, KMH, PAKH, Nirmal, Anand, GynaecWorld
23. Hospitals-Prince Aly Khan, BEAMS, Kodlikeri, ReGenesis, Anand, Nirmal
24. Infotech - Lexicon, Syntel, Vakrangee, Wipro
25. Laboratory - Padmaja, RRTL, Cera Lab
26. Leather - Superhouse, BASF,
27. Lubes - Lubrizol, Standard Greases, Pennzoil, RPJ,
28. Manning - Expo,
29. Medical Devices - Media - Himedia, Warkem,
30. Medical Devices - IVD - Accurex, Tulip Group of Companies
31. Medical Devices - Bandages - Smith + Nephew
32. Medical Devices - Electrical - HCL Tech, Celetronix Power, Red Rocket, Portescap Danaher
33. Metal forms - Accurate, Precision, Metal Craft, Wirecom, Krombach, Mill Max, Vijay Alloys, Govan
34. Metallurgy - Sterlite, Hindustan Zinc, NDMB C.No. 8, R&C,
35. Minerals - Selective Minerals
36. OTC Products - Dr. Reddy's Lab (FTO-III), Elysium, Madras Pharmaceuticals, Softgel
37. Paint - Asian PPG, Kwality, Metcon
38. Pharmaceuticals-Jenberkt, Themis Lab, Sun, Concept, Cadilla, Vamsi, Smruthi, Phoenix, Navketan, Hemkish, Dr. Reddy's Lab, Elysium, Softgel, Madras Pharmaceuticals,
39. Plastics and Rubber - Rover, Zenith, BSES, Elastimold, Hind Cables, Lloyds, Gaurav, Kisan, Tesa, Newtex, Precitex, Nagreeka, DgC, Gem,
40. Seeds and Grains - Bejo Sheetal, Rentio, Kogta, Sagar
41. Ship Recycling (Breaking) - Shree Ram Group of Companies, Alang
42. Sky Chefs (Airline Catering) - Ambassador Skychef, Muthoot, Oberoi Flight Services
43. Sports wear - Forma, Protech
44. Sugar - Ugar, Natural, Manjara, Pannageshwar, Akaluj, Sangamner,
45. Tea estates - Jayshree, Assam, Nilgiri
46. Textiles - Dhayfule, Phundipalle, Filatex, Tulsiani, Colourtex, Sagar Twisters, Dodhia Textiles,
47. Utensils & Accessories - Duraware, Nirlep

Training Experience (1997...till date...)

More than 100 Taining Programs were planned and conducted till date

1. IRCA Approved Internal Auditors Training Course(R-234) by World wide Quality Management Network (WQMN) London, UK (11)
2. IRCA Approved Lead Assessor/ Auditors Training Course (A-5700) by World wide Quality Management Network (WQMN) London, UK (10)
3. NABAT Certified Lead Auditor Training Courses (LQ-101) for ISO 9001: 2000 (8)
4. NABAT Certified (Internal) Auditor Training Course ISO 9001: 2000 (9)
5. NABAT Certified (Internal) Transition Auditor Training Course (TQ-101) (2)
6. IRCA Approved Internal Auditors Training Course (R-234) by World wide Quality Management Network (WQMN) London, UK-Review of ISO 9001:2000 FDIS QMS Requirements and Draft ISO 19011 (4)
7. ISO 14001: 2004 – EMS Internal Auditors’ Training Programs (10)
8. Food Safety / HACCP Awareness Training Progams (12)
9. HACCP Internal Auditors' Training Program (2)
10. ISO 22000: 2005 Awareness Training Programs (3)
11. ISO 13485: 2003 Awareness Training Programs (5)
12. ISO 13485: 2003 Internal Auditor's Training Programs (2)
13. IRCA IATCA Approved (A17190) Lead Auditor Course (2)
14. IRCA Approved Internal Auditor Course - EMS - BSI EN06 - (1)
15. IRCA Approved Internal Auditor Course - BSI QMS - QU-29 (1)
16. IRCA Approved Lead Auditor Courses - BSI QU-30 (6)
17. IRCA Approved Lead Auditor Course - BSI QU-30 - ISO 9001: 2008 (1)
18. IRCA Approved BSI QMS 04101 ENIN 9001 2008 Auditor/Lead Auditor Training Courses (3)
19. Available for Private Work

Work Experience 1976-1996

Total 21 + Years
1. Polypharm Pvt. Limited - Analytical Chemist - 1976
2. Indofil Chemicals Limited - Process Control Chemist - 1977
3. Roche Products Limited - Process Control Chemist - 1978-84
4. Fulford India Limited - Quality Assurance Exec. - 1984-92
5. Indoco Remedies Limited - Manager - QA Manager & MR - 1992-95
6. Advanced Biochemicals Ltd. - Manager - QA Manager & MR - 1995-96


Current occupation 
1. IRCA Registered QMS 2008 Lead Auditor Cert. No. A 015076with Expertise in Agriculture and fishing, Chemicals, Chemical products and Fibres, Education, Food Products, Beverages and tobacco, Pharmaceuticals and available for Private Work........Refer www.irca.org
2. IES College - CCDC - Visiting Faculty for 'QA in Healthcare and Pharmaceuticals' since 2000
3. Empanelled Lead Auditor with Certification Bodies for QMS / EMS / FSMS / cGMP / GCP / CE Certifications and Markings since 1997
4. External Resource (ER) and Lead Tutor for IRCA Approved Auditor / Lead Auditor Training Courses on ISO 9001: 2008 (QMS), ISO 14001: 2004 (EMS) and ISO 22000: 2005 (FSMS)

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