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Recommended Conferences for Quality Regulation

Quality Regulation

As per available reports about10 relevant journals, 71 Conferences, 6 workshops are presently dedicated exclusively to Quality Regulation and about 1543 articles are being published on Quality Regulation.

QS Regulation: The QS regulation embraces constant "umbrella'' approach to the CGMP regulation that was the underpinning of the initial CGMP regulation. as a result of the regulation should apply to such a lot of differing kinds of devices, the regulation doesn't order thoroughly however a manufacturer should turn out a selected device. In 1990, government agency undertook the beginning of the revision of the CGMP regulation to feature the planning controls licensed by the Safe Medical Devices Act. Also, the agency believed that it might be useful to the general public and therefore the medical device business for the CGMP regulation to be consistent, to the extent attainable, with the necessities for quality systems contained in applicable international standards, primarily, the global organization for Standards (ISO) 9001:1994

OMICS International Organizes 1000+ Global Events Every Year across USA, Europe & Asia with support from 1000 more scientific societies and Publishes 700+ Open access journals which contains over 100000 eminent personalities, reputed scientists as editorial board and organizing committee members. The conference series website will provide you list and details about the conference organize worldwide.

Scope and Importance

 "Quality Systems--Model for Quality Assurance in style, Development, Production, Installation, and coupling,” and at the time the ISO committee draft (CD) revision of ISO/CD 13485 "Quality Systems--Medical Devices--Supplementary needs to ISO 9001.” once an intensive effort, the half 820 revision was printed on Oct seven, one996 (61 francium 52602) and went into result June 1, 1997. for extra data on the history and international harmonization of the revised regulation, with international standards and therefore the world Harmonization Task Force (GHTF), see the preamble (pages 52602 - 52654) to the standard System regulation (61 francium 52602), government agency has known within the QS regulation the essential components that a top quality system shall embody, while not prescribing specific ways that to determine these components. as a result of the QS regulation covers a broad spectrum of devices, production processes, etc., it permits some leeway within the details of quality system components. it's left to makers to work out the requirement for, or extent of, some quality components and to develop and implement specific procedures tailored to their specific processes and devices.
Applicability of the QS Regulation: The QS regulation applies to finished device makers UN agency shall commercially distribute medical devices. A finished device is outlined in twenty one CFR 820.3(l) as any device or accent to any device that's appropriate to be used or capable of functioning, whether or not or not it's prepackaged, labeled, or sterilized. sure parts like blood tube and diagnostic x-ray parts square measure thought of by government agency to be finished devices as a result of they're accessories to finished devices. A manufacturer of accessories is subject to the QS regulation.GMP Exemptions: FDA has determined that sure kinds of medical devices square measure exempt from GMP needs. These devices square measure exempted by government agency classification rules printed within the Federal Register and written in twenty one CFR 862 to 892. Exemption from the GMP needs doesn't exempt makers of finished devices from keeping grievance files (21 CFR 820.198) or from general needs regarding records (21 CFR 820.180). Medical devices factory-made underneath associate investigational device exemption (IDE) aren't exempt from style management needs underneath twenty one CFR 820.30 of the QS regulation.
Additional Quality System data: Quality System (QS) Regulation: twenty one CFR 820, Medical Device Quality System Regulation and Preamble, Quality System Regulation and Preamble. Quality System Regulation steerage Documents: (Withdrawn) Medical Device Quality Systems Manual Quality System data for sure Premarket Application Reviews; steerage for business and government agency employees Design managements: style Control steerage For Medical Device makers Human Factors: Human Factors and Medical Devices; steerage for business and government agency Premarket and style management Reviewers - Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management, bonk on purpose - associate Introduction to Human Factors in Medical Devices

Market Analysis

The market was valued at US$1.56 billion in 2013 and is estimated to reach a value of US$4.49 billion by the end of 2020.With the help of regulatory affairs outsourcing, life science, pharmaceutical, and medical device manufacturing companies are able to get their drugs or devices approved or launched in the global market. Regulatory affairs outsourcing by biopharmaceutical companies has minimized losses due to recalls and product approval delays. Regulatory affairs service providers also provide effective services such as clinical trial services, medical writing, and pharmacovigilance to biotech, pharma, and medical device companies.

International symposium and workshops

  • VIth Asia pacific pharma congress on July 14-16, 2016 , Kuala lumpur, Malaysia.
  • VIIth   Annual global Pharma Summit June 20-22, 2016 New Orleans, USA
  • Vth  Global Pharmacists Annual Meeting July 11-13, 2016 Brisbane, Australia

          List of Best International Conferences

  • 6th Pharmaceutical Regulatory Affairs and IPR Conference September 12-14, 2016 San Atonio, USA
  • 7th Analytical and Bioanalytical Techniques Conference, September 29-October 01, 2016 Miami, USA
  • Pharma Conference, August 25-27, 2015 Valencia, Spain
  • 8th Pharmaceutics and Novel Drug Delivery Systems Conference, March 07-09, 2016 Madrid, Spain
  • Drug Formulation and Bioavailability Conference June 06-08, 2016 Beijing, China
  • Pharma Marketing Conference November 17-19, 2016 Alicante, Spain
  • 6th Pharmacovigilance Conference Canada August 01-03, 2016 Toronto, Canada
  • 4th  GMP, GCP and Quality Control Conference October 26-28, 2015 Hyderabad, India
  • Pharma Conference Middle East November 02-04, 2015 Dubai, UAE
  • Industrial Pharmacy Conference April 11-12, 2016 Dubai, UAE
  • 3rd Annual International Conference on Pharmacology and Pharmaceutical Sciences (PHARMA) 26-27 October 2015, Bangkok Thailand
  •  Pharma Africa Market Access Conference 24 - 25 September 2015 London, UK
  •  International Conference and Expo on Bio pharmaceutics September 21-22, 2015 Baltimore, MD, USA 

    Relevant Companies
    •Abbott Laboratories
    •Ego Pharmaceuticals
    •Eli Lilly and Company
    •General Pharma
    •Getz Pharma
    •Glenmark Pharmaceuticals
    •Avella Specialty Pharmacy
    •Axcan Pharma
    •Aurobindo Pharma
    •Daiichi Sankyo
    •Dainippon Sumitomo Pharma
    •Dawakhana Shifaul Amraz
    •Diabetology Ltd
    •Diffusion Pharmaceuticals
    •Dr. Reddy's Laboratories
    Relevant Associations
    •Regulations & Guidelines - Indian Pharmaceutical Association
    •Drugs Control - Indian Pharmacist Association
    •Central Drugs Standard Control Organization
    •Indian Drug Manufacturers' Association
    •DIA- Drug Information Association
    •The California Naturopathic Doctors Association
    •Texas Pharmacy Today - Texas Pharmacy Association
    •International Harm Reduction Association
    •American Pharmacists Association (APhA)
    •American Society for Pharmacy Law
    •American Society of Consultant Pharmacists Foundation
    •American Society of Consultant Pharmacists (ASCP)
    •American Society of Health-System Pharmacists (ASHP)
    •National Community Pharmacists Association (NCPA)
    •International Pharmaceutical Federation (FIP)
    •European Pharmaceutical Union (EPU)
    •Pharmaceutical Group of the European Union (PGEU)
    •European Association of Employed Community Pharmacists in Europe (EPhEU)
    •Pharmaceutical Society of Australia
    •The Brazilian Association of Regulatory Agencies
    •Insurance Regulatory Committee
    •Compliance & Regulation(IBABC)
    •EAP: Regulations
    •Amusement Ride Safety Regulations and Standards (IAAPA)
    •Commonwealth Pharmacists Association (CPA)

This page will be updated regularly.

This page was last updated on 14th Sep, 2015

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