Theme: Manufacturing and quality guidelines: Its importance creates its need!

GMP Summit 2017

GMP Summit 2017

Conference Series LLC is a renowned organization that organizes highly notable Conferences throughout the globe. Currently we are bringing forth “6th International Summit on GMP, GCP & Quality Control” (GMP Summit 2017) scheduled to be held during September 25-26, 2017 at Chicago, USA. The conference invites all the participants across the globe to attend and share their insights and convey recent innovations in pharmaceutical sciences, manufacturing, quality control aspects with strong emphasis on originality and scientific quality.

The main theme of the conference is “Manufacturing and quality guidelines: Its importance creates its need!”.

Conference Series LLC organizes a conference series of 1000+ Global Events inclusive of 1000+ Conferences, 500+ Upcoming and Previous Symposiums and Workshops in USA, Europe & Asia with support from 1000 more scientific societies and publishes 700+ Open access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

2017 Highlights:

  • 300+ Participation (70 Industry: 30 Academia)
  • 5+ Keynote Speakers
  • 50+ Plenary Speakers
  • 20+ Exhibitors
  • 14 Innovative Educational Sessions
  • 5+ Workshops
  • B2B Meetings

Conference Series LLC Conferences invites all the participants from all over the world to attend ‘6th International Summit on GMP, GCP & Quality Control (GMP Summit 2017)' during September 25-26, 2017 at Chicago, USA which covers on all aspects of the pharmaceutical sciences, manufacturing, quality with strong emphasis on originality and scientific quality.

The main theme of the conference is “Manufacturing and quality guidelines: Its importance creates its need!

GMP Summit 2017 is the learning of ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Advanced studies are being made to improvise quality of products, reduce safety risk and cost, and enhance international credibility and public image and many more.

Conference Series LLC organizes a conference series of 3000+ Global Events inclusive of 600+ Conferences, 1200+ Upcoming and Previous Symposiums and Workshops in USA, Europe & Asia with support from 1000 more scientific societies and publishes 700+ Open access Journals which contains over 70000 eminent personalities, reputed scientists as editorial board members.

Track-1: Good Manufacturing Practices: The Gap Within

Good Manufacturing Practice is the part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate to their intended use and as required by the marketing authorization, clinical trial authorization or product specification. Good Manufacturing practices conference aims at both production and Quality Control. Current Good Manufacturing Practices (cGMP) is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products. FDA regulates the quality of pharmaceuticals very carefully. Current Trends in the FDA is the main regulatory standard for ensuring pharmaceutical quality.

Related Conferences:

2nd Global Pharmaceutical Industry Summit, April 17-19, 2017, Zurich, Switzerland; 2nd Pharma Marketing Conference, November 02-03, 2017, Las Vegas, USA; 7th Pharmaceutical Conference on Regulatory Affairs and IPR, Sep 25-26, 2017 Chicago, USA; 2nd International Conference on Generic Drug Market and Contract Manufacturing, Sep 25-27, 2017 Berlin, Germany; 9th Biologics and Biosimilars Conference, October 05-06, 2017 Atlanta, USA; 22nd Annual GMP by The Sea, August 28-30, 2017, Cambridge, USA; IFPAC 2017 Annual Meeting, February 27- March 2, 2017, Besthesda, USA; 2017; Pharma Congress Production & Technology, March 28-29, 2017, Dusseldorf, Germany; Africa Pharma Summit 2017, February 15-16, 2017, Nairobi, Kenya; BIOMEDevice Conference & Expo, May 3-4, 2017, Boston, USA; International Pharmaceutical Federation (FIP), Pharmaceutical Society of Australia, Chinese Pharmaceutical Association, American Association of Pharmaceutical Scientists (AAPS), Austrian Pharmaceutical Society (APS).

Track-2: Current Regulations and Quality Standards

Roles of pharmaceutical inspection convention and co-operation scheme (PIC/S) are to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the pharmaceutical industry. The FDA regulations and CFR are responsible for protecting and promoting public health through the regulation and supervision of all the products available in the market to ensure patient compliance. EU-GMP guidelines are needed to maintain the products quality which is stricter when compared to WHO-GMP guidelines.

Related Conferences:

2nd Global Pharmaceutical Industry Summit, April 17-19, 2017, Zurich, Switzerland; 2nd Pharma Marketing Conference, November 02-03, 2017, Las Vegas, USA; 7th Pharmaceutical Conference on Regulatory Affairs and IPR, Sep 25-26, 2017 Chicago, USA; 2nd International Conference on Generic Drug Market and Contract Manufacturing, Sep 25-27, 2017 Berlin, Germany; 9th Biologics and Biosimilars Conference, October 05-06, 2017 Atlanta, USA;  FDA Clinical Trial Requirements Regulations, Compliance and GCP Conference, November 15-16, 2017, Orlando, USA; Device Research & Regulatory Conference, April 05-07, 2017, Scottsdale, USA; 2017 ISPE/FDA Quality Manufacturing Conference, June 05 – 07, 2017, Arlington, USA; Pharmaceutical Regulatory Summit China, March 28-31, 2017, Shanghai, China; RAPS 2017, September 17-21, 2017; Canadian Society for Pharmaceutical Sciences (CSPS), Drug Information Association (DIA), International Society for Pharmaceutical Engineering (ISPE), National Association of Pharmacy Regulatory Authorities (NAPRA), Pharmaceutical Research and Manufacturers of America (PhRMA).

Track-3: Current GMP Guidelines (cGMP)

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the US FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.

Related Conferences:

2nd Global Pharmaceutical Industry Summit, April 17-19, 2017, Zurich, Switzerland; 2nd Pharma Marketing Conference, November 02-03, 2017, Las Vegas, USA; 7th Pharmaceutical Conference on Regulatory Affairs and IPR, Sep 25-26, 2017 Chicago, USA; 2nd International Conference on Generic Drug Market and Contract Manufacturing, Sep 25-27, 2017 Berlin, Germany; 9th Biologics and Biosimilars Conference, October 05-06, 2017 Atlanta, USA; 5th Annual Corporate Compliance & Transparency in the Pharmaceutical Industry, February 22- 23, 2017, Zurich, Switzerland; PCC 2017 - CBI’s 14th Annual Pharmaceutical Compliance Congress, April 27-28, 2017, Washington, DC, USA; Pharmaceutical Compliance Congress Canada, June 6-7, 2017, Toronto, Canada; Pharma CI Conference & Exhibition, February 21-22, 2017, Prague, Czech Republic; Making pharmaceuticals Conference & Exhibition, April 25-26, Ricoh Arena, UK; Regulatory Affairs Professionals Society (RAPS), Food & Drug Administration (FDA) ,The European Federation of Pharmaceutical Industries and Associations (EFPIA), The European Generic Medicines Association (EGA), The Controlled Release Society (CRS).

Track-4: The Role of 'c' in cGMP

The CGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the "C" in CGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's quality standards.

Related Conferences:

2nd Global Pharmaceutical Industry Summit, April 17-19, 2017, Zurich, Switzerland; 2nd Pharma Marketing Conference, November 02-03, 2017, Las Vegas, USA; 7th Pharmaceutical Conference on Regulatory Affairs and IPR, Sep 25-26, 2017 Chicago, USA; 2nd International Conference on Generic Drug Market and Contract Manufacturing, Sep 25-27, 2017 Berlin, Germany; 9th Biologics and Biosimilars Conference, October 05-06, 2017 Atlanta, USA;  2017 ISPE Europe Annual Conference, April 03-06, 2017, Barcelona, Spain; 3rd International medical Expo & Conference, February 15-17, Osaka, Japan; 22nd Annual GMP by The Sea, August 28-30, 2017, Cambridge, USA; IFPAC 2017 Annual Meeting, February 27- March 2, 2017, Besthesda, USA; 2017; Pharma Congress Production & Technology, March 28-29, 2017, Dusseldorf, Germany; Regulatory Affairs Professionals Society (RAPS), Food & Drug Administration (FDA) ,The European Federation of Pharmaceutical Industries and Associations (EFPIA), National Association of Pharmacy Regulatory Authorities (NAPRA), Pharmaceutical Research and Manufacturers of America (PhRMA).

Track-5: Good Clinical Practices and Good Laboratory Practices

The role of ICH in designing GCP principles is to provide an ethical treatment to the subjects who are involved in the clinical trials. Conference on Good Clinical Practices is important because it is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. The GLP Principles describe requirements for and provide general guidance on the conduct of all nonclinical health and environmental safety studies, including invitro studies. Pre-clinical trials assess the toxicity of a drug and examine its potential effects on the human body. These trials are conducted in-vitro which is required to proceed with clinical trials. Good laboratory practices should be followed for these pre-clinical trials.

Related Conferences:

9th Conference on Pharmacovigilance, July 17-19, 2017, Munich, Germany; 6th  World Congress on Pharmacology, August 07-09, 2017, Paris, France; 4th Clinical Trials Conference, September 11-13, 2017 San Antonio, USA; 10th Pharmacovigilance Congress, September 28-29, 2017 Houston, USA; 2nd Global Pharmaceutical Industry Summit, April 17-19, 2017, Zurich, Switzerland; 8th Global Pharmacovigilance Summit, April 17-18, 2017, Bali, Indonesia; FDA Clinical Trial Requirements Regulations, Compliance and GCP Conference, May 03-04, 2017, Indianapolis, USA; Clinical Site Coordinator / Manager and GCP Workshop, July 13-14, 2017, NewJersey, USA; World Drug Safety Americas 2017, April 19 – 20, 2017, Chicago, USA; 8th Proactive GCP Compliance, April 2017, Philadelphia, USA; Oncology Clinical Trials Conference, March 30-31, 2017, Newport Beach, USA; The European Personalized Medicine Association (EPEMED), The Institute of Clinical Research (ICR), The BioIndustry Association (BIA), Canadian Generic Pharmaceutical Association (CGPA), The British Generic Manufacturers Association.

Track-6: Quality Control

Quality control (QC) is a procedure or set of procedures intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria that meets the requirements of the client or customer. A major aspect of quality control is the establishment of well-defined controls. These controls help standardize both production and reactions to quality issues. The role of Quality Impact Assessment & effectiveness checks is an essential operation of the pharmaceutical industry. To Perform Quality Control process of Project Management several quality control tools and software’s are required. Quality control also plays a major role in analytical method development so it would be great to attend the quality control summit.

Related Conferences:

8th Analytical & Bioanalytical Techniques Conference, October 16-18, 2017, Milan, Italy; 8th Annual Pharmaceutical Analysis Conference, Sep 25-27, 2017, Vienna, Austria; 3rd  Separation Techniques Conference, October 23-25, 2017 Paris, France; Pharmaceutical Methods Development and Validation Conference, Oct 22-24, 2017, Paris, France; 5th Conference on Mass spectrometry, Dec 12-14, 2017, Kualalumpur, Malaysia; 6th FIP Pharmaceutical Sciences World Congress 2017, May 21-24, 2017, Stockholm, Sweden; 2017 PDA Annual Meeting, Apr 03-05, 2017, Anaheim, CA; 13th Annual Quality in Pharma & Biotech 2017; BioPharma World Expo 2017, February 14-17, 2017, Mumbai, India; PHARM Connect Congress, February 22-23, 2017, Budapest, Hungary; Generic Pharmaceutical Association, National Association of Pharmaceutical Manufacturers, European Generic medicines Association, Generic Pharmaceutical Manufacturers Association, European Association of Euro-Pharmaceutical Companies (EAEPC).

Track-7: Quality Assurance

Quality assurance is defined as a procedure or set of procedures intended to ensure that a product or service under development meets specified requirements. A quality assurance system is said to increase customer confidence and a company's credibility, to improve work processes and efficiency, and to enable a company to better compete with others. Quality assurance conferences aims at the need for Effective Internal and External Quality Assurance Auditing and it is required, by all active pharmaceutical ingredient (API)/bulk pharmaceutical chemical, medical device and finished pharmaceutical cGMP regulations published worldwide. Quality assurance testing is done by using software called Quality Metrics.

Related Conferences:

8th Analytical & Bioanalytical Techniques Conference, October 16-18, 2017, Milan, Italy; 8th Annual Pharmaceutical Analysis Conference, Sep 25-27, 2017, Vienna, Austria; 3rd  Separation Techniques Conference, October 23-25, 2017 Paris, France;  Pharmaceutical Methods Development and Validation Conference, Oct 22-24, 2017, Paris, France; 5th Conference on Mass spectrometry, Dec 12-14, 2017, Kualalumpur, Malaysia; 2017 ISPE/FDA Quality Manufacturing Conference, 05 June 2017 - 07 June 2017, Arlington, USA;  Qbd in Pharma Development World Congress 2017, April 20-22, 2017, Hyderabad, India; World Conference on Quality and Improvement, May 01-03, 2017, Charlotte, USA; 2017 PDA Annual Meeting, Apr 03-05, 2017, Anaheim, CA; 13th Annual Quality in Pharma & Biotech 2017; Japan Generic Pharmaceutical Manufacturers Association, Association of the British Pharmaceutical Industry, Pharmaceutical Association for the Development of the Republic of China (CPMDA), The Danish Association of the Pharmaceutical Industry, Belgian Pharmaceutical Industry Association.

Track-8: Validation

Validation means establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. Validation is an integral part of quality assurance; it involves the systematic study of systems, facilities and processes aimed at determining whether they perform their intended functions adequately and consistently as specified. The Major Phases of validation include Pre validation, Process Validation and Validation maintenance Phase.

Related Conferences:

2nd Pharma Marketing Conference, November 02-03, 2017, Las Vegas, USA; 2nd Global Pharmaceutical Industry Summit, April 17-19, 2017, Zurich, Switzerland; 7th Pharmaceutical Conference on Regulatory Affairs and IPR, Sep 25-26, 2017 Chicago, USA; 2nd International Conference on Generic Drug Market and Contract Manufacturing, Sep 25-27, 2017 Berlin, Germany; 9th Biologics and Biosimilars Conference, October 05-06, 2017 Atlanta, USA;  2017 ISPE Data Integrity Workshop, 04 June 2017 - 04 June 2017, Arlington, USA; Process Validation Summit, May 2017, Philadelphia, USA; ECA Cleaning Validation Conference, February 09-10, 2017, Heidelberg, Germany; International Workshop on Validation of Test Methods, 23 January 2017, Tel Aviv, Israel; Target Identification & Validation Summit, February 8-9, 2017, San Diego, USA; Generic Pharmaceutical Manufacturers Association, European Association of Euro-Pharmaceutical Companies (EAEPC), The European Federation of Pharmaceutical Industries and Associations (EFPIA), The European Generic Medicines Association (EGA), The Controlled Release Society (CRS).

Track-9: Contract & Sterile/Aseptic Manufacturing

Traditional role of Contract manufacturing, also known as outsource manufacturing, is to produce one or more components of a final product in which a company relies on the skills of specialist manufacturers. Six sigma is a long-term, forward-thinking initiative designed to fundamentally change the way corporations do business. It is first and foremost "a business process that enables companies to increase profits dramatically by streamlining operations, improving quality, and eliminating defects or mistakes in everything a company does. Aseptic/sterile production and injectable manufacturing processes require a significant investment in terms of expertise, equipment, process, technology and quality control.

Related Conferences:

2nd Pharma Marketing Conference, November 02-03, 2017, Las Vegas, USA; 2nd Global Pharmaceutical Industry Summit, April 17-19, 2017, Zurich, Switzerland; 7th Pharmaceutical Conference on Regulatory Affairs and IPR, Sep 25-26, 2017 Chicago, USA; 2nd International Conference on Generic Drug Market and Contract Manufacturing, Sep 25-27, 2017 Berlin, Germany; 9th Biologics and Biosimilars Conference, October 05-06, 2017 Atlanta, USA;   2017 ISPE Aseptic Conference, March 07-08, 2017, Reston, USA; Outsourced Pharma Conference and Exhibition, April 26-27, 2017, Boston, USA; Lean and Six sigma conference, February 27-28, 2017, Phoenix, USA; Atlantic Design & Manufacturing Conference, June 13 - 15, 2017, New York, USA; PHARM Connect Congress, February 22-23, 2017, Budapest, Hungary; Canadian Society for Pharmaceutical Sciences (CSPS), Drug Information Association (DIA), Society for Pharmaceutical Engineering (ISPE), The European Generic Medicines Association (EGA), The Controlled Release Society (CRS).

Track-10: Storage, Distribution, Transportation

Cold chain storage is a temperature-controlled supply chain. An unbroken cold chain is an uninterrupted series of storage and distribution activities which maintain a given temperature range. It is used to help extend and ensure the shelf life of pharmaceutical drugs. Good distribution practice (GDP) deals with the guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs intended for human consumption. Supply Chain integrity, enable qualified firms to expedite the importation of active pharmaceutical ingredients and finished drug products.

Related Conferences:

2nd Pharma Marketing Conference, November 02-03, 2017, Las Vegas, USA; 2nd Global Pharmaceutical Industry Summit, April 17-19, 2017, Zurich, Switzerland; 7th Pharmaceutical Conference on Regulatory Affairs and IPR, Sep 25-26, 2017 Chicago, USA; 2nd International Conference on Generic Drug Market and Contract Manufacturing, Sep 25-27, 2017 Berlin, Germany; 9th Biologics and Biosimilars Conference, October 05-06, 2017 Atlanta, USA; 9th Annual Pharma Packaging and Labeling 2017, February 22-23, 2017, Philadelphia, USA; The Global Leading Pharma Supply Chain Event, April 25 - 27, 2017, Montreux, Switzerland; Clinical Trial Supply Europe, January 16 - 18, 2017, London, UK; Cool Chain -2017, January 31 – February 02, 2017, London, UK; Lyophilization Forum, June 2017, Philadelphia, USA; PHARM Connect Congress, February 22-23, 2017, Budapest, Hungary; International Pharmaceutical Federation (FIP), Pharmaceutical Society of Australia, Chinese Pharmaceutical Association, American Association of Pharmaceutical Scientists (AAPS), Canadian Generic Pharmaceutical Association (CGPA).

Track-11: Formulation Development

Formulation development is to be done only after successful completion of pre-formulation studies. Optimization of existing formulations is required to create new products, Reduce costs, to capitalize on trends with greater profitability, novel formulations for improved delivery of existing dosage forms, to quickly recalculate formulations based on defined criteria, to create compliant products faster by using existing validated formulas. Product/Process optimization is the practice of making changes or adjustments to a process such as Conjoint Analysis, typically used in industrial process optimization.

Related Conferences:

2nd Drug Formulation & Bioavailability Congress, May 8-10, 2017 Berlin, Germany; 3rd Biopharmaceutics Conference, Jun 22-23, 2017 Baltimore, USA; 10th Conference on Pharmaceutics & Novel Drug Delivery Systems, March 13-15, 2017, London, UK; 10th Asia-Pacific Pharma Congress, July 24-26, 2017 Melbourne, Australia; 11th World Drug Delivery Summit, October 16-18, 2017 New York, USA; 6th FIP Pharmaceutical Sciences World Congress 2017, May 21-24, 2017, Stockholm, Sweden; CBI’s 3rd annual Abuse Deterrent Formulations Summit, March 8-9, 2017, Alexandria, USA; Africa Pharmaceutical Summit 2017, February 15 - 16, 2017, Nairobi, Kenya; International Conference and Exhibition on Pharmaceutical Development and Technology, April 24-26, 2017, Dubai, UAE; 6th Annual American Drug Delivery & Formulation Summit & Expo, August 28-29, 2017, Boston, USA; The European Personalized Medicine Association (EPEMED), The Institute of Clinical Research (ICR), The BioIndustry Association (BIA), Canadian Generic Pharmaceutical Association (CGPA), The British Generic Manufacturers Association.

Track-12: GMP in Food Industry

The Quality control in typical food processing has a significant role in assuming a high quality, safe and nutritious food supply for the public, for their good health and for the economic benefits derived from trade of safe and high quality food. Quality control conference also plays a major role in food industry. Hazard Analysis & Critical Control Points (HACCP) is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. Food, Drug, and Cosmetic Act is a set of laws giving authority to the US-FDA to oversee the food safety, safety of drugs, and cosmetics. Cleaning, disinfection and hygiene should be strictly maintained in food industry.

Related Conferences:

20th Global Food Processing Summit, October 5-7, 2017 Chicago, USA; 2nd Pharma Marketing Conference, November 02-03, 2017 Las Vegas, USA; 6th Conference on Food Safety and Regulatory Measures, June 5-7, 2017 Milan, Italy; 2nd Conference on Generic Drug Market and Contract Manufacturing, Sep 25-27, 2017 Berlin, Germany; 9th Conference on Global Food Safety, December 04-06, 2017 Atlanta, USA; IFPAC® - 2017 Food Quality, Safety & Analysis, February 27- March 2, 2017, North Bethesda, USA; The Food Defense Conference 2017, May 03-04, 2017, Minneapolis, USA; Global Food Safety Conference, February 27 – March 02, 2017, Houston, USA; Food Safety Americas 2017, April 4 – 5, 2017, Orlando, USA; Food Safety Summit, May 8-11, 2017, Rosemont, USA; Generic Pharmaceutical Manufacturers Association, European Association of Euro-Pharmaceutical Companies (EAEPC), The European Federation of Pharmaceutical Industries and Associations (EFPIA), The European Generic Medicines Association (EGA), The Controlled Release Society (CRS).

Track-13: GMP in Microbiology and Biotechnology

Microbiological Assay is defined as the determination or estimation of concentration or potency of an antibiotic by means of measuring and comparing the area of zone of inhibition or turbidity produced by test substance with that of standard over a suitable microbe under standard conditions. FDA 510k Testing regulation is found in 21 CFR 807 includes information required in a 510(k). The 510(k) is not a form. Cleaning, disinfection and hygiene should be strictly maintained in Microbiology and Biotechnology.

Related Conferences:

2nd Conference on Food Microbiology, September 28-30, 2017 Madrid, Spain; 2nd Pharma Marketing Conference, November 02-03, 2017 Las Vegas, USA; 15th World Congress on Biotechnology and Biotech Industries, March 20-21, 2017, Rome, Italy; 2nd Conference on Generic Drug Market and Contract Manufacturing, September 25-27, 2017 Berlin, Germany; Biotechnology World Convention, June 22-23, 2017, Baltimore, USA; AAPS National Biotechnology Conference, 28 April 2017- 04 May 2017, San Diego, USA; 2017 PDA Europe: Pharmaceutical Microbiology, February 14-15, 2017, Porto, Portugal; Global Pharmaceutical Microbiology Conference, June 19-20, 2017, Westminster, UK; The Microbiology Society Annual Conference 2017, April 03-06, 2017, Edinburgh, UK; The BIO International Convention (BIO) 2017, June 19-22, 2017, San Diego, USA; International Pharmaceutical Federation (FIP), Pharmaceutical Society of Australia, Chinese Pharmaceutical Association, American Association of Pharmaceutical Scientists (AAPS), Austrian Pharmaceutical Society (APS).

Track-14: Softwares in GMP and GCP

The use of GMP software systems in regulated industries is vital throughout all aspects of the manufacturing process. Quality management software provides a flexible and configurable platform for tracking and managing quality and regulatory compliance events to ensure that manufacturing activities are continually measured, monitored and improved upon.  In addition to managing all aspects of the audit process, GMP software solution manages the associated findings or observations, corrective and preventive actions (CAPAs), risk assessment, risk management and the analysis and approvals of changes. This software also manages deviations, process validation, complaint handling, manufacturing incidents, training records and more.

Related Conferences:

8th Analytical & Bioanalytical Techniques Conference, October 16-18, 2017, Milan, Italy; 3rd  Separation Techniques Conference, October 23-25, 2017 Paris, France;  Pharmaceutical Methods Development and Validation Conference, Oct 22-24, 2017, Paris, France; 7th Pharmaceutical Conference on Regulatory Affairs and IPR, Sep 25-26, 2017 Chicago, USA; 2nd International Conference on Generic Drug Market and Contract Manufacturing, Sep 25-27, 2017 Berlin, Germany; Making pharmaceuticals Conference & Exhibition, April 25-26, Ricoh Arena, UK; 2017 ISPE Data Integrity Workshop, 04 June 2017 - 04 June 2017, Arlington, USA; Process Validation Summit, May 2017, Philadelphia, USA; International Workshop on Validation of Test Methods, 23 January 2017, Tel Aviv, Israel; Target Identification & Validation Summit, February 8-9, 2017, San Diego, USA; Japan Generic Pharmaceutical Manufacturers Association, Association of the British Pharmaceutical Industry, Pharmaceutical Association for the Development of the Republic of China (CPMDA), The Danish Association of the Pharmaceutical Industry, Belgian Pharmaceutical Industry Association.

Summary:

GMP Summit 2017 welcomes attendees, presenters, and exhibitors from all over the world to Chicago, USA. We are delighted to invite you all to attend and register for the “6th International Summit on GMP, GCP & Quality Control (GMP Summit 2017) which is going to be held during September 25-26, 2017 at Chicago, USA. The organizing committee is gearing up for an exciting and informative conference program including plenary lectures, symposia, workshops on a variety of topics, poster presentations and various programs for participants from all over the world. We invite you to join us at the GMP Summit 2017, where you will be sure to have a meaningful experience with scholars from around the world. All the members of GMP Summit 2017 organizing committee look forward to meet you at Chicago, USA.

Importance and Scope:

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Advanced studies are being made to improvise quality of products, reduce safety risk and cost, and enhance international credibility and public image and many more.

Why Chicago, USA?

Chicago is the 3rd largest gross metropolitan city in the United States and about $630.3 billion according to 2014-2016 estimates. The city has also been rated as having the most balanced economy in the United States, due to its high level of diversification. Chicago was named the fourth most important business center in the world. Additionally, the Chicago metropolitan area recorded the greatest number of new or expanded corporate facilities in the United States for the year 2014. Chicago is a major world financial center, with the 2nd largest central business district in the United States. The city is the headquarters of the Federal Reserve Bank of Chicago. The city has major financial and futures exchanges, including the Chicago Stock Exchange, the Chicago Board Options Exchange and the Chicago Mercantile Exchange etc.

Manufacturing, printing, publishing and food processing also play major roles in the city's economy. Several medical products and services companies are headquartered in the Chicago area, including Baxter International, Boeing, Abbott Laboratories, and the Healthcare Financial Services division of General Electric. In addition to Boeing, which located its headquarters in Chicago in 2001, and United Airlines in 2011, GE Transportation moved its offices to the city in 2013, as did ThyssenKrupp North America. In addition, the state of Illinois is home to 66 Fortune 1000 companies, including those in Chicago. The city of Chicago also hosts 12 Fortune Global 500 companies and 17 Financial Times 500 companies.

 Conference Highlights

  • Good Manufacturing Practices: The Gap within
  • Current Regulations and Quality Standards
  • Current GMP Guidelines (cGMP)
  • The Role of c in cGMP
  • Good Clinical Practices & Good Laboratory Practices
  • Quality Control
  • Quality Assurance
  • Validation
  • Contract & Sterile/Aseptic Manufacturing
  • Storage, Distribution, Transportation
  • Formulation Development
  • GMP in Food Industry
  • GMP in Microbiology and Biotechnology
  • Softwares in GMP and GCP

Societies Associated with Pharma manufacturing Industries

City (Chicago):

  • Chicago Intellectual Property Alliance
  • Chicago Manufacturing Renaissance Council
  • Institute of Food Technologists

Major Associations around USA:

  • Drug Information Association (DIA)
  • Generic Pharmaceutical Association (GPhA)
  • Pharmaceutical Research and Manufacturers of America (PhRMA)
  • The Pharmaceutical Research and Manufacturers of America (PhRMA)
  • The American Association of Pharmaceutical Scientists (AAPS)
  • Generic Pharmaceutical Association (GPhA)

Major Associations around Globe:

  • International Federation of Pharmaceutical Manufacturers Associations (IFPMA)
  • International Pharmaceutical Excipients Council (IPEC)
  • International Pharmaceutical Federation (FIP)
  • International Society for Pharmaceutical Engineering (ISPE)
  • Parenteral Drug Association (PDA)
  • Regulatory Affairs Professionals Society (RAPS)
  • The Pharmaceutical Research and Manufacturers of America (PhRMA)
  • The European Federation of Pharmaceutical Industries and Associations (EFPIA)
  • The American Association of Pharmaceutical Scientists (AAPS)
  • The European Generic Medicines Association (EGA)
  • EFPIA - The European Pharmaceutical Industry Association
  • European Generic Medicines Association
  • The British Generic Manufacturers Association
  • Association of the British Pharmaceutical Industry
  • Generic Pharmaceutical Manufacturers Association
  • Generic Pharmaceutical Association
  • European Generic medicines Association
  • Canadian Generic Pharmaceutical Association
  • Japan Generic Pharmaceutical Manufacturers Association

Statistics:

List of Pharmaceutical Industries:

City (Chicago):

  • Abbott Laboratories
  • Abbvie
  • Astellas Pharmaceuticals
  • Baxter International
  • Hospira
  • Marathon Pharmaceuticals
  • Takeda Pharmaceuticals

Major Pharmaceutical Industries around USA:

  • Johnson and Johnson             
  • Pfizer
  • Abbott Laboratories
  • Bristol Myers Squibb
  • Amgen
  • Biogen Idec
  • Celgene Corporation
  • Merck & Co
  • Gilead Sciences
  • Eli Lilly

Worldwide:

  • Abbott Laboratories
  • AbbVie
  • Actavis
  • Actelion
  • Baxter International
  • Biocon
  • Biogen Idec
  • Boehringer-Ingelheim
  • Bristol-Myers Squibb
  • Hetero Drugs
  • Hoffmann–La Roche
  • Intas Biopharmaceuticals
  • Johnson & Johnson
  • Lupin Limited
  • Merck & Co.
  • Mylan
  • Novartis
  • Novo Nordisk
  • Procter & Gamble
  • Purdue Pharma
  • Sun Pharmaceutical
  • Takeda Pharmaceutical Co.
  • Teva Pharmaceuticals
  • Torrent Pharmaceuticals
  • Vertex Pharmaceuticals
  • Wockhardt

Statistical Representation:

Target Audience:

The target audience will from the pharmaceutical, food, and biotechnology industries in Canada, associations and societies of Canada, students and professors from the academia of the various universities, researchers, scientists, experts, business delegates in the field of Pharmaceutical Sciences. 

Global Market Analysis for GMP:

The global market for pharmaceutical and biopharmaceutical contract manufacturing, research and packaging was $219.9 billion in 2012. This market is estimated to reach $242.2 billion in 2013 and $374.8 billion by 2018, a five-year compound annual growth rate (CAGR) of 9.1%.

Statistical Representation

GLOBAL Statistics:

  • Global spending on medicines is forecast to reach nearly $1.3 trillion by 2018
  • 21 pharmerging countries will increase their contribution to growth over the next five years and account for nearly 50% of absolute growth in 2018.
  • The pharmerging markets will expand at a compound annual growth rate of 8-11% through 2018
  • Total global spending will reach $1.3 trillion in 2018, an increase of $290-320 billion from 2013, driven by population growth, an aging population, and improved access in pharmerging markets.
  • A compound annual growth rate of 4-7% on a constant currency basis, will be slightly higher than the 5.2% recorded over the past five years

Statistics of the Pharmaceutical Industry in the U.S.

The U.S. pharmaceutical market is the world’s most important national market. Together with Canada and Mexico, it represents the largest continental pharma market worldwide. The United States alone holds some 40 percent of the global pharmaceutical market. In 2014, this share was valued around 365 million U.S. dollars. Many of the global top companies are located in the United States. In 2014, six out of the top eleven companies were U.S. based.

Funds allotted to Pharmaceutical Research:

Worldwide:

Pharmaceutical companies have traditionally funded their internal R&D efforts totally on their own by investing 15% or more of their top line revenues to pay for these endeavours’. In addition, in order to tap into R&D going on outside their companies, pharmaceutical companies has financially supported external R&D efforts in deals with small biotech companies, research institutes, and universities. In fact, as funding for agencies like the NIH has stagnated over recent years, pharma has become an important source of funds to support early stage research.

The R&D Funding Forecast notes that there is a continuing shift in where R&D investments are being made, with fewer in the U.S. and Europe and more in Asian countries. The U.S. now accounts for less than a third of global spending, while Europe’s 34 countries account for less than 22% and Asian countries account for nearly 40%, a trend that has continued for the past five years. This trend is expected to continue through the end of the decade with China’s R&D investments surpassing those of the U.S. by about 2022.

Members Associated with Pharmaceutical Research:

In regard to Industrial personnel:

Research Positions:-

  • Lab technician
  • Research Associate
  • Research Scientist

Clinical Development and medical Jobs:

  • Clinical Research Physician
  • Clinical Research Associate
  • Regulatory Affairs Associate
  • Bio Statistician
  • Clinical Data Manager
  • Medical Science Liaison

Manufacturing and Quality Assurance Jobs:

  • Process Engineer
  • Quality Control Analyst
  • Quality Assurance Specialist

Business Operations Jobs:

  • Market research Analyst
  • Associate Product Manager
  • Product Manager
  • Strategy Director
  • Business Development Manager

 

GMP Summit 2016

Conference Series LLC successfully anchored its leading "5th International Summit on GMP, GCP and Quality Controlslated on August 12-13, 2016 at Holiday Inn Toronto International Airport, Toronto, Canada.

GMP Summit 2016 brought together the International blend of people from pharmaceutical, biotech, food, healthcare & medical devices companies, business entrepreneurs, pharmaceutical consultants, leading universities and research institutions making it the largest endeavor from Conference Series LLC. This has provided a unique opportunity for academic and industry-wide communication and collaboration.

GMP Summit 2016 conference received salutations by the honorable guests Mohammed R KhanSynergex Consulting, Canada, Boyd L Summers, BL Summers Consulting LLC, USA and is moderated by Nadia NarineLumar Food Safety Services, Canada.

The conference was initiated with the honorable presence of the Keynote forum. The list includes:

  • Mohammed R Khan, Synergex Consulting, Canada.
  • Boyd L Summers, BL Summers Consulting LLC, USA.
  • Kenneth Christie, VTS Consultants, Inc., USA.
  • Danuta Radzioch, Mcgill University and Laurent Pharmaceuticals, Canada.
  • Rashid Mahmood, Surge Laboratories Private Limited, Pakistan.

The 5th International Summit on GMP, GCP and Quality Control was based on the theme Taking on challenges and exploring opportunities to achieve Compliance and ensuring great Quality Products" which has encrusted the below scientific sessions:

  • Good Manufacturing Practices: The Gap within
  • Current Regulations and Quality Standards
  • Current GMP Guidelines (cGMP)
  • The Role of 'c' in cGMP
  • Good Clinical Practices & Good Laboratory Practices
  • Quality Control
  • Quality Assurance
  • Validation
  • Contract & Sterile/Aseptic Manufacturing
  • Storage, Distribution, Transportation
  • Formulation Development
  • GMP in Food Industry
  • GMP in Microbiology and Biotechnology
  • Softwares in GMP & GCP

Conference Series LLC offers its heartfelt appreciation to the Keynote speakers and esteemed organizations, obliged to the Organizing Committee Members, adepts of field, various outside experts, company representatives and other eminent personalities who supported the conference by facilitating the discussion forums. Conference Series LLC also took privilege to felicitate the Organizing Committee Members, Editorial Board Members and Media Partners who supported this event.

Following on the heels of this successful event we are excited to announce, Conference Series LLC is proud to announce the "6th International Summit on GMP, GCP and Quality Control (GMP Summit 2017)" going to be held during September 25-26, 2017 at Chicago, USA.

2017 Highlights:

  • 300+ Participation (70 Industry: 30 Academia)
  • 5+ Keynote Speakers
  • 50+ Plenary Speakers
  • 20+ Exhibitors
  • 14 Innovative Educational Sessions
  • 5+ Workshops
  • B2B Meetings

For More details visithttp://gmp-gcp-quality-control.pharmaceuticalconferences.com/


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