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  #2  
27th October 2014, 01:17 PM
Super Moderator
 
Join Date: Apr 2013
Re: GMP Auditor Courses

Auditing is a important role inside a pharmaceutical company. It presents administration with detail info. on the subject of how successfully the group run the excellence of their method and goods. Auditors should make their jobs expertly to make sure their company’s observance with pharmaceutical USFDA GMP regulations and other quality standards like ICH Q10. Auditing for GMP is particularly planned to deal with the confront of GMP auditing for the pharmaceutical industry.

COURSE ELIGIBILITY:
Eligibility : B.Pharm, M Pharm, BSc., MSc., B Chem, M Chem, Doctorates in science disciplines, BE, DE.

DURATION : 10 MONTHS

COURSE PROGRAMME:
Part 1: Auditing Basics

Purpose of audits and audit models (overview)
Role Characteristics of the Auditor
Audit Types and Classification
Audit Methods
General Themes for All Audits

Part 2: Auditing Tools and Techniques

Basic auditing tools
Audit Techniques
Audit scheduling, planning and management

Part 3: The audit process

Audit scheduling
Conducting the audit
Managing an Audit Team
The Exit Meeting
Audit Reporting and closeout

Part 4: Improving the audit system

Adding Value from the Audit programme
Organisation of the internal audit programme (Self Inspection)

Part 5: How to Audit CAPA, OOS and QRM

The necessity for structured investigation
Corrective and Preventive Action procedures
Out of Specification procedures
Risk Assessment techniques

Part 6: Auditing API Manufacturers

Why Audit API Manufacturers
What is different about API operations"
Control of raw materials and process intermediates
Handling Manufacturing Deviations
QC Laboratories
Distribution
Computer systems
QP Declaration

Part 7: Auditing Products Manufacturers

Oral solid and liquid dosage forms
Packaging and labelling
Distribution
QC Laboratories
Computer systems

Part 8: Auditing for Approval of Contractors / Suppliers

Technical requirements (physical properties, purity, quantity, frequency, etc)
Critical steps and controls
Preferred location (UK, EU, Far East, world-wide)
Key points of contract (Quality Technical Agreement)

Following Is the institute that Offer GMP Auditor Course:

CONTACT DETAIL:
Pharma Courses Ltd
Suite 1327 Kemp House
152 City Road
London
EC1V 2NX
Telephone +44 (0)20 71937703
  #3  
21st March 2015, 03:26 PM
Unregistered
Guest
 
Re: GMP Auditor Courses

Can you list me the names of courses that offered under Good Manufacturing Practices (GMP) as I want to take admission in it? List me the names of some good institutes that offer the courses?
  #4  
21st March 2015, 03:35 PM
Super Moderator
 
Join Date: Apr 2013
Re: GMP Auditor Courses

Good manufacturing practices (GMP) are the practices required in order to conform to guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.


International Society for Pharmaceutical Engineering
No. 2236 Chino Roces Avenue 1231, Philippines ‎

University College Cork
Coláiste Na Hollscoile, Bóthar an Choláiste, Corcaigh, Ireland ‎

PharmaTraining Ltd
152 City Road, London EC1V 2NX, United Kingdom ‎

ISPE
600 N. Westshore Blvd., Suite 900 Tampa, Florida 33609 USA

ISPE China
Level 4, Puxi Management Center, No. 801 Jumen Road Shanghai 200023, China –

Ontario College of Technology
4002 Sheppard Ave. East, Suite 308
Toronto, Ontario, Canada M1S 1S6

The Center for Professional Advancement
190 Rt. 18 Suite 203
East Brunswick, NJ USA 08816

NIHR Biomedical Research Centre at Guy's and St Thomas' NHS Foundation Trust and King's College London
16th Floor Tower Wing
Guy’s Hospital
London
SE1 9RT

GMP Training Courses
Quality Systems
Facilities and Equipment Systems
Materials Systems
Production Systems
Packaging and Labeling Systems
Laboratory Control Systems
Certified Process Validation Professional (CPVP)
Current Good Manufacturing Practices (cGMP) Certified Professional (GMPCP)
Pharmaceutical Development Certified Professional (PDCP)
cGMP Quality Principles
Effective Risk-Based Applications of Drug cGMPs
Good Manufacturing Practices (cGMP)


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