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Recommended Conferences for Design Controls

Design Controls


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

Design Controls designates the application of a formal methodology to the conduct of product development activities. It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries. Design controls are an interconnected set of practices and procedures that are incorporated into the design and development process, i.e., a system of checks and balances. Design controls make systematic assessment of the design an integral part of development. As a result, deficiencies in design input requirements, and discrepancies between the proposed designs and requirements, are made evident and corrected earlier in the development process.

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Scope and Importance

Design controls increase the likelihood that the design transferred to production will translate into a device that is appropriate for its intended use.“Design controls” is a broad term that describes several procedures and processes used throughout the design and manufacture of a product, the basic focus of which are to ensure the most effective product design and that what is produced consistently reflects that design and the product's intended use. Design inputs, outputs, review, change controls, validation, verification, transfer, and the design history file all constitute aspects of design controls. Having effective design controls in place can go a long way in preventing and bolstering the defense against products-liability claims alleging a design defect—one of three bases for products liability. The basic allegation behind a design-defect claim is that a safer design exists for the product in question, but that the manufacturer failed to use the safer design. Robust design controls help to ensure that the safest, technologically feasible, design for the product is being used. Further, in the event of litigation, design controls can be used by the manufacturer to demonstrate that the risks associated with alternative designs were weighed and considered.
In addition to creating products liability risks for design flaws, failure to institute sufficient design controls is likely to result in regulatory actions. Design controls constitute about a quarter of what the FDA evaluates during a site inspection. This emphasis appears to be appropriate, as the FDA found that approximately 44 percent of the quality problems that led to voluntary recall actions during a six-year period in the 1990’s may have been prevented by adequate design controls As a significant part of the FDA’s focus in inspections, it is not surprising that 55 percent of Warning Letters issued in 2010 cited design controls as a deficiency’s. Design controls not only assure the most efficacious product design and that design inputs meet outputs, design controls also have important advantages for regulatory compliance and products-liability avoidance. Design controls are a component of a comprehensive quality system that covers the life of a device. The assurance process is a total systems approach that extends from the development of device requirements through design, production, distribution, use, maintenance, and eventually, obsolescence. Design control begins with development and approval of design inputs, and includes the design of a device and the associated manufacturing processes. Design control does not end with the transfer of a design to production. Design control applies to all changes to the device or manufacturing process design, including those occurring long after a device has been introduced to the market. This includes evolutionary changes such as performance enhancements as well as revolutionary changes such as corrective actions resulting from the analysis of failed product. The changes are part of a continuous, ongoing effort to design and develop a device that meets the needs of the user and/or patient. Thus, the design control process is revisited many times during the life of a product.
 

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 Antonio, 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
    •GlaxoSmithKline
    •Glenmark Pharmaceuticals
    •Pharmacosmos
    •Avella Specialty Pharmacy
    •Axcan Pharma
    •Aurobindo Pharma
    •Daiichi Sankyo
    •Dainippon Sumitomo Pharma
    •Dawakhana Shifaul Amraz
    •Debiopharm
    •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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