"GMP rules. GMP Audit"

Invited Trainers:

Dr. Werner Gielsdorf, HSC- Germany

General Manager of TACIS project of European Commission in CIS, Manager of UNCTAD, WTO, ITC ,

EU, World Bank, UNCTAD/WTO,

trainer of GCP, GLP, GDP,GMP,

(Curriculum Vitae)

Dr.Zadorin Eugene, PhD, MBA
International BioPharmaceutical Association,
Gerson
Lehrman healthcare Council, First Clinical Research LLC Speakers
Bureau, former head of consulting Group of the Department of Clinical Research

( 2006-2008 ).(Curriculum Vitae)

What is cGMP?

Current Good Manufacturing Practices (cGMP) consist of the regulations, guidelines and recommended practices issued by the FDA and other international regulatory authorities as well as current industry practice.  They form the basis for production and testing of pharmaceutical products that are safe and effective for human use.  Regulatory publications are necessarily vague so that manufacturers have the opportunity to incorporate innovations into their products.  Thus the practitioner of cGMP must strive to be up to date on the latest innovations.  cGMP compliance ensures that the products produced meet specific requirements for identity, strength, quality, and purity.  FDA regulates practitioners of cGMP using the following tools:

21 CFR Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, Or Holding Of Drugs; General Part

21 CFR Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals

21 CFR Part 600 - Biological Products: General

21 CFR Part 11 - Electronic Records; Electronic Signatures

Registration

Accreditation

International accreditation has been requested from:
HSC-Germany ,NBScience

GMP training certification

GMP training certification is the formal recognition of clinical research professionals who have met professional eligibility requirements and demonstrated job-related knowledge and skills. The NBScience's certification is granted in recognition of documented and verified work experience and successful performance on a multiple-choice exam.

Sponsoring & Exhibition

Social program

Visa procedure

Hotels

Training Topics:

Background

• Documents
• Regulatory and Advisory Bodies
• Definitions

Annexe 13

• Content
• Implications

New EU Guideline on IMPs and Non-IMPs

• Content
• Implications

Requirements for Manufacturing

• What constitutes manufacturing
• Role of QP
• Licenses required

Site Management of IMP

• Personnel
• Premises
• Equipment

Registration

The success of the NBScience international is built on forging profitable business relationships between the Pharmaceutical and Biotechnology industries and their partners in clinical research.
With our 5 years of experience in increasing our partners' return on investment we've developed winning strategies guaranteed to build and sustain successful partnerships in clinical trials outsourcing.

• pharmaceutical companies
• CRO
• Investigators
• GCP,cGMP auditors

NBScience already has many partnerships with societies, universities, statutory organisations and NGOs locally, nationally and internationally. We aim to strengthen these relationships and develop new collaborations in the future.