Validation and Pharmacovigilance Conference 2020

New York, USA

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About Conference

The Validation and Pharmacovigilance conference 2020 is an unparalleled event which draws young professionals to the senior-most executives of pharmaceutical and biopharmaceutical industry-related drug manufacturing, supply chain, devices and equipment and services, and global regulatory agencies. The conference leads the path to most advanced technological solutions to the pharmaceutical industry.

The two-day conference brings along the business leaders on science and risk- and statistics-based validation. The conference transcends way beyond best apply and consists of both Presentations and workshops on completely different aspects of cleansing validation and Pharmacovigilance. Attendees can thus gain a deeper understanding of the new Standards, use of statistics in validation, further as risk analysis and data integrity in validation - among different things and end to end Pharmacovigilance Services from data entry to regulatory Submissions. United Pharma Technologies concentrates on Pre-Clinical and Post marketing cases together with AE, SAE, Initial Receipt, case process, follow-up, medical review and case closure.

In addition to the various presentations and workshops, the conference also provides several opportunities for networking. Also it allows you to seek concerning individual presentations within the full agenda.

Conference objectives: The key objective of this conference is to provide participants with sensible data and understanding of regulatory needs and techniques that may be placed to use in their own validation strategy. The presenters can specialise in the foremost recent information offered and can cowl a good vary of subjects relevant to cleaning validation.

The conference is primarily relevant for R&D staff, Leaders, Supporters, Validation teams in production and Quality Assurance seeking the latest knowledge about risk- and statistics-based cleaning validation, as well as for engineering companies wanting to learn more about the viewpoint of the pharmaceutical industry and exchanging experiences.

Top Reasons to Attend:

With like minds around the globe, determined to learn about the validation and Pharmacovigilance and its advances in the recent times, and to pave a distinct path, this is your best chance to arrive at the biggest congress of members from the Pharmacovigilance domain. This could be the best place to conduct, convey valuable research information, interact with potential researchers, make a mark with innovative drug advancements, and receive recognition at this 2-days event. This is a great platform with renowned speakers from around the world, with latest advancements, and most recent studies in Pharmacovigilance.

  • Risk based implementation  
  • Study of Validation Master Plan (VMP)
  • Set up submissive Continued Process Verification (CPV) process
  • Leverage technology transfer
  • Discover Quality by Design (QbD) approach
  • Procedure Performance Qualification (PPQ)
  • Develop gap analysis list  
  • Importance of statistics in process validation
  • Effective approach for combination products

Must Attend areas of study:

  • Validation
  • QA/QC
  • Engineering  
  • Regulatory Affairs
  • Compliance
  • Manufacturing
  • Laboratory

Target Audience:

  • Pharmacovigilance Students, Scientists
  • Validation engineers
  • Validation analysts
  • Pharmacovigilance Researchers
  • Pharmacovigilance Faculty
  • Medical Colleges
  • Pharmacovigilance Associations and Societies
  • Business Entrepreneurs
  • Training Institutes
  • Software Developing Companies
  • Manufacturing Medical Devices Companies
  • Data Management Companies

The vantage point of pharma industry, towards the contract manufacturing organizations, has been ever changing. The working process is volatile, due to increase in pressure on quality, cost and scalability. These factors control and determine not just, to which manufacturer the industry outsources to, but the number of manufacturers as well.

Considering this, we have designed a most intuitive and interactive 2-day program, to give the pharrna industry a chance to talk about their biggest challenges that they are facing at the moment. If you are looking for something which can streamline your external work of CMO, or to find out the best practices and factors in selecting the CMO, this is the best place to acknowledge and find solutions. We agree that, managing emerging markets, and the lever expertise to assess the external partners, without compromising the quality aspect is one of the prime concerns in the present market. So we assure you, to identify all your concerns and guide you through the entire business process.

Tracks:

Track:1 Validation:

Pharmaceutical facilities consist of various processes, and the accuracy of each process is of utmost importance to ensure that the end product is of high quality. Validation is the most recognized and most important parameter of GMPs. The process validation is the most important aspect according to the U.S. Food and Drug Administration (FDA) in pharmaceutical manufacturing. Our attempt is to present an introduction and bring forward a general overview on process validation of pharmaceutical manufacturing process. Quality cannot just rely on sampling, testing, release of materials and products. Quality check should not be a process done at the end, but instead, quality assurance techniques, should be incorporated at every step to build a quality product. Process validation of a process ensures production of drug with reproducible quality. Process Validation performs this task to build quality into the product, as it had proven to be an important aspect for quality management of pharmaceuticals according to ISO 9000:2000.

Track: 2 Importance of validation:

  • Increased throughput
  • More rapid and reliable start up of new equipment
  • Easier scale-up from development work
  • More rapid automation
  • Reduction in utility cost

Track: 3 Process Validation: General Principles and Practices

This guidance aligns process validation activities with a product lifecycle concept and with existing FDA guidance, including the FDA/International Conference on Harmonisation (ICH) guidances for industry, Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. 2 Although this guidance does not repeat the concepts and principles explained in those guidances, FDA encourages the use of modern pharmaceutical development concepts, quality risk management, and quality systems at all stages of the manufacturing process lifecycle.

Track: 4 Process Validation and Drug Quality:

The Process Validation is generally seen as the collection and evaluation of data, from the design state to the commercial production stage. This establishes the evidence, if a process is effectively capable of delivering the same quality consistently each time the drug is produced. This principle also brings forward the understanding that the below conditions exist:

  • Product is built and designed with Quality, safety and efficacy.
  • In-process or finished-product inspection and testing cannot guarantee Quality.