Pravin Gothe

Products and Services Offered

2007-05-10T20:30:00.006+05:30

First Party, Second Party and Third Party Audits of Management Systems for

QMS ISO 9001: 2008

UNI 10854: 1999

QMS ISO 13485: 2003, 93/42/EEC (MDD), 98/79/EC (IVD), CE Mark

EMS ISO 14001: 2004

GLP ISO 17025: 2005

FSMS ISO 22000: 2005

ICH Q7A, 21 CFR 210, 21 CFR 211, 21 CFR 820, 21 CFR 11

cGMP, Product and Process Audits for Food, Drug and Cosmetics

Risk Management and Analysis, OHS Assessment
EFfCI GMP Guide 2008 - The European Federation for Cosmetic Ingredients
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 : -

Documentation for QMS/EMS/FSMS/CE/cGMP/WHO

Internal Auditors Training

Training and Development for Managment Systems

Lead Auditors Training

Documentation for Laboratory Accreditation
Second Party (Global Customer) Audits

Contact on: pravingothe@gmail.com

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

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

API - Alchymars (AIS), ACI (Bangladesh), Aptuit Laurus, Divis, Dr Reddy's Lab, Jubilant, Innovasynth, Cadilla, Smruthi Organics, Sun, Gulbrandsen, Neuland Lab, Mehta API, Anuh Pharma, Spectrochem,
Animal feed - Sabar, Amul, Sumul, Sundara Agro
Beverages - Bombay Breweries, Champagne Indage, Parle, Marico
Biologicals - BASF, Phoenix, Syngenta, Sumitomo Chemicals
Cargo - GATI, A-1,
Cement - C. Raghoji, Ambuja BCT
Ceramics - SunEarth, H&R Johnson
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,
Clinical Research Organizations (CRO) - SIRO Clinpharm
Confectionary - Cadbury's, Parle, Amul Chocolates at Mogar
Cosmetics - Gulbrandsen, Godrej, Royal Castor Products
Dyes - Zenith Intermediates,
Dairy Products - Baroda, Gokul, Kheda, Madhur, Mother, Panch Mahal, Sabar, Sagar, Sumul, Vasudhara, Uttam, Saurash
Education - Bright Schools, DAV Schools, CCDC at IES College, Dr. BS Konkan Krishi Vidyapeeth at Dapoli
Electricals - KC Fixtures, FCG, Govan, Intek IRD, Cona, Keystone, Situ, Axis, Paramount, Torsion, Meta Clad,
Electroplating - Progressive Electroplating
Foods - Multania Bread, Ruchi Soya, Priya, Temptation, Taj Fresh, Ekta, Madhav, HLL, Sona, CavinKare
Food Chemicals - Royal Castor, RPG Life Science, Everest, TabCoat, Selective, Rhodea, AIMCO,
Food Edible Oils - Bunge at Trichy, Liberty Oil Mills, Ruchi Soya,
Food & Pharma Packaging - Essel Propack, IPN, Kaira Can, Arrow, FLoeter India, Kris Flexi, Pearl Polymers
Heavy Enginering - Carriage Workshop, Ajmer, Richardson & Cruddas, Govan, Indian Valves, NDMB C. No. 33,
Healthcare Specialities - ARF - Rotunda, ReGenesis, Sperm Processor, KMH, PAKH, Nirmal, Anand, GynaecWorld
Hospitals-Prince Aly Khan, BEAMS, Kodlikeri, ReGenesis, Anand, Nirmal
Infotech - Lexicon, Syntel, Vakrangee, Wipro
Laboratory - Padmaja, RRTL, Cera Lab
Leather - Superhouse, BASF,
Lubes - Lubrizol, Standard Greases, Pennzoil, RPJ,
Manning - Expo,
Medical Devices - Media - Himedia, Warkem,
Medical Devices - IVD - Accurex, Tulip Group of Companies
Medical Devices - Bandages - Smith + Nephew
Medical Devices - Electrical - HCL Tech, Celetronix Power, Red Rocket, Portescap Danaher
Metal forms - Accurate, Precision, Metal Craft, Wirecom, Krombach, Mill Max, Vijay Alloys, Govan
Metallurgy - Sterlite, Hindustan Zinc, NDMB C.No. 8, R&C,
Minerals - Selective Minerals
OTC Products - Dr. Reddy's Lab (FTO-III), Elysium, Madras Pharmaceuticals, Softgel
Paint - Asian PPG, Kwality, Metcon
Pharmaceuticals-Jenberkt, Themis Lab, Sun, Concept, Cadilla, Vamsi, Smruthi, Phoenix, Navketan, Hemkish, Dr. Reddy's Lab, Elysium, Softgel, Madras Pharmaceuticals,
Pharma Packaging - Pioneer extruder, Essel Propack, Kris Flexi, KK foils, Ishan Industries, Jeevanlakshmi, Paper Products Ltd, Impress, Pearl Polymers, Bilcare, SS Enterprises, Webtech, Interlabels, EssDee, Rajesh Plastics
Plastics and Rubber - Rover, Zenith, BSES, Elastimold, Hind Cables, Lloyds, Gaurav, Kisan, Tesa, Newtex, Precitex, Nagreeka, DgC, Gem,
Seeds and Grains - Bejo Sheetal, Rentio, Kogta, Sagar
Ship Recycling (Breaking) - Shree Ram Group of Companies, Alang
Sky Chefs (Airline Catering) - Ambassador Skychef, Muthoot, Oberoi Flight Services
Sports wear - Forma, Protech
Sugar - Ugar, Natural, Manjara, Pannageshwar, Akaluj, Sangamner,
Tea estates - Jayshree, Assam, Nilgiri
Textiles - Dhayfule, Phundipalle, Filatex, Tulsiani, Colourtex, Sagar Twisters, Dodhia Textiles,
Utensils & Accessories - Duraware, Nirlep

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

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More than 100 Taining Programs were planned and conducted till date

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

Work Experience 1976-1996

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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 015076 with 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)