International Conference and Expo on Separation Techniques August 10-12, 2015 San Francisco, USA

Welcome to the Separation Technique 2015 Conference.
This high profile conference to be held in beautiful San Francisco in August 2105, will cover the multiple aspects of Separation Techniques; from distillation to chromatography but also from analytical tools to production perspectives. Experts from all fields involving Separation Techniques are expected to attend and provide the latest trends and developments in their fields. Separation Technique – 2015 will bring high level scientists from academia and industry together to discuss technologies applications as well as analytical tools that are essential to the development of new products. Having the possibility to learn the state of the art in your technology is one of the benefits but being able to also explore alternate techniques and to discover other fields of application is what makes this conference so valuable. Either through lectures, seminars or workshops sessions throughout the three day conference, young scientist as well as seasoned experts can learn from Separation Technology 2015. Finally this world class conference will be a unique opportunity to network with chemists, engineers as well as executives and VPs.
We hope sincerely that your participation to the International Expo on Separation Techniques will be an unforgettable and productive scientific event.

yours sincerely,
Olivier Dapremont, Ph.D.

Executive Director, Process Technologies
AMPAC Fine Chemicals LLC
USA

GMP-definition is the validation of "establishing documented evidence that establishes a high degree of certainty that a particular process will consistently a product that provides the previously established specifications and quality attributes are available."Appropriate and complete documentation is recognized as crucial for the validation. Standard Operating Procedures (SOPs), production formulas, detaileddocumentation batch changeControl, experimental reporting systems, analytical documents, reports development, validation protocols and reports are an integral part of validation philosophy. The validation of the documentation provides a source of information for the ongoing operation of the plant and is a resource that is used in the subsequent process of development or modification activities.All test activities will take a level of impact assessment to ensure that systems, services andProducts were determined directly affected by the test.

Track 2:Quality Assurance and Quality Control 

The process of making sure that the stakeholders are adhered to the defined standards and procedures is called quality control. In quality control, a verification process takes place.

Certain activities and products are verified against a defined set of rules or standards.

Every organization that practices QC needs to have a Quality Manual. The quality manual outlines the quality focus and the objectives in the organization.

The quality manual gives the quality guidance to different departments and functions. Therefore, everyone in the organization needs to be aware of his or her responsibilities mentioned in the quality manual.

Quality Assurance is a broad practice used for assuring the quality of products or services. There are many differences between quality control and quality assurance.

In quality assurance, a constant effort is made to enhance the quality practices in the organization.

Therefore, continuous improvements are expected in quality functions in the company. For this, there is a dedicated quality assurance team commission.

Track 3: Clinical Trials in Validation of Drugs

many Pharma companies have built experienced biomarker teams internally that are responsible for delivering appropriate biomarkers for new agents in their pipeline. The strategy employed by many of these companies is that the biomarker validation and early clinical trials of the drug/biomarker combination is outsourced to companies such as Almac Diagnostics. The advantage of this approach is that the drug can be killed quickly if efficacy is not seen in the biomarker selected population. When a biomarker is discovered in a pre-clinical setting, there are a number of important considerations that must be accommodated prior to its implementation clinically. Most commonly, the first consideration is the migration of the assay to an appropriate tissue and / or platform. Commonly, preclinical biomarker studies are carried out on cell line or animal models using fresh tissue, so a migration study is usually required as the tissue to be tested will often be formalin fixed and paraffin embedded (FFPE). Another form of migration we often have to consider is a platform migration. When discovery has been carried out on a platform such as microarray or next generation sequencing, the delivery of a clinical diagnostic may be better suited to a qPCR based platform, depending on the number of genes in the signature. Typically we carry out both a platform and tissue migration, often moving from a signature discovered from fresh tissue using a microarray to a qPCR panel optimized for performance in FFFPE.

Track 4.Hybrid Techniques in validation

Track 5: Advances in Validation Techniques

Bioanalytical method validation is a mandatory step to evaluate the ability of developed methods to provide accurate results for their routine application in order to trust the critical decisions that will be made with them. Even if several guidelines exist to help perform bioanalytical method validations, there is still the need to clarify the meaning and interpretation of bioanalytical method validation criteria and methodology. Yet, different interpretations can be made of the validation guidelines as well as for the definitions of the validation criteria. This will lead to diverse experimental designs implemented to try fulfilling these criteria. Finally, different decision methodologies can also be interpreted from these guidelines. Therefore, the risk that a validated bioanalytical method may be unfit for its future purpose will depend on analysts personal interpretation of these guidelines. The objective of this review is thus to discuss and highlight several essential aspects of methods validation, not only restricted to chromatographic ones but also to ligand binding assays owing to their increasing role in biopharmaceutical industries. The points that will be reviewed are the common validation criteria, which are selectivity, standard curve, trueness, precision, accuracy, limits of quantification and range, dilutional integrity and analyte stability. Definitions, methodology, experimental design and decision criteria are reviewed. Two other points closely connected to method validation are also examined: incurred sample reproducibility testing and measurement uncertainty as they are highly linked to bioanalytical results reliability. Their additional implementation is foreseen to strongly reduce the risk of having validated a bioanalytical method unfit for its purpose.

Track 6: Novel Approaches in Validation Techniques

Track 7: Pharmacovigilance and Regulatory Aspects

Pharmacovigilance is governed by mandatory regulations issued by medicines regulatory authorities world wide, and it is imperative that pharmaceutical companies are compliant with these. The CIOMS and ICH organizations have contributed significantly to the harmonization of the various national regulations, with the aim of defining a single set of globally accepted standards and requirements. However, there are still regional and national variations. In chapter we review the evolution of pharmacovigilance regulations to date, followed by a more detailed appraisal of the regulations themselves, focusing mainly on the regulatory framework in the three ICH Regions—Europe, the USA, and Japan—and indicating key aspects of global harmonization and variation. Pharmaceutical regulations continue to develop and evolve, and it is therefore impossible to provide a comprehensive account of all current regulatory aspects of pharmacovigilance in a book chapter. Readers are therefore strongly advised to consult local and regional regulatory documents, in order to obtain the detailed and up-to-date understanding necessary to ensure compliance with regulatory aspects of pharmacovigilance.

Track 8: Applications in Validation of Drugs

The application of a good Process Validation is critical for pharmaceutical and biotech organizations.  To assist industry, several guidances have been developed by regulatory agencies in the last few years that define the requirements and best practices for the effective implementation of Process Validation. 

Organizations that fail to develop an effective process validation system will face significant regulatory consequences including For Cause audits by regulators, recalls or plant closure.  However, the application of process validation is not limited to the manufacturer; it also extends to include suppliers.  Regulations have also been established which direct organizations to assess the adequacy of process validation activities at their suppliers.  For example, regulators expect organizations to begin process validation activities before new equipment is installed.

Track 9: Future Prospects of Validation

Interest in drug use among America's major ethnic minority groups is rapidly increasing. Despite the welcomed interest, researchers tend to use broad ethnic labels to identify their samples. Such labels as "ethnic glosses" provide little information concerning the heterogeneity of each ethnic group and, in most instances, violate the guidelines concerning appropriate descriptions of sample characteristics. Use of broad ethnic descriptors particularly in drug use research creates external validity problems and prevents replications. Researchers are encouraged to obtain detailed information on the sociocultural characteristics of their samples by obtaining measures on ethnic identification, situated identity, and acculturative status. Use of ethnic identity and acculturation measures, however, can create problems in defining appropriate sample frames.

Track 10: Pharma Market Audit

Marketing audit, which business schools now teach to students from all sectors, is very useful to high-performing brands and companies to help identify which aspects of the spend works hardest. The factors driving success can be more accurately identified, enabling more precise targeting of resources to maintain competitive edge. Marketing audit also helps underachieving brands as it will identify how and where performance can be improved and how budgets can be more effectively deployed.