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Bio/Pharma in China: New Initiatives, New Opportunities
Part 1: Wednesday, May 18, 2016 at 11:00 am EDT | 8:00 am PDT | 4:00 pm BST | 5:00 pm CEST

Part 2: Thursday, May 19, 2016 at 11:00 am EDT | 8:00 am PDT | 4:00 pm BST | 5:00 pm CEST


The China Food and Drug Administration is to moving upgrade the country’s bio/pharmaceutical industry including new manufacturing operations that meet Western standards to meet the medicinal needs of the nation’s population. In this webcast, experts offer insight into opportunities for Western bio/pharmaceutical companies in China, and address lingering and unexpected questions about doing business there.

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Sponsor: CPhI China


Drug Stability Testing from Development to Shipping
Wednesday, April 27, 2016, 11 am CEST

In this educational webcast, learn about regulatory expectations and practical approaches to stability testing of drug substances and drug products for clinical trials, packaging, storage, and transportation.

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Sponsor: SGS Life Science Services


Employing a Lean Lab Approach to Optimize Lab Processes: Part 1 "Work smarter not harder"
Tuesday, April 26, 2016 | 10:00 AM EDT

When lab workloads seem too high to handle, analysis results or approvals are late, or lead times are exceeded, it is time to take a closer look at a lean lab approach, especially before investing in new resources such as equipment, premises, or personnel.

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Sponsor: Mettler Toledo


ON DEMAND WEBCASTS

Continuous Manufacturing of Pharmaceuticals: Scale-up of a Hot-Melt Extrusion Process

Available until April 14, 2017

An understanding of the variable process parameters that have a significant impact on the final pharmaceutical product is necessary to successfully manage a hot-melt extrusion process when using twin-screw extrusion. Experts will discuss residence time, mechanical-energy consumption, and other critical parameters, as well as their effects on a scientific approach to process scale-up. 

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Sponsor: Therm Fisher Scientific


How will you respond when the FDA asks: “Are you effectively monitoring your subcontractors?

Available Until March 23, 2017

Join this informative webinar to learn how to foster relationships with contract partners to develop a quality surveillance program that will meet FDA scrutiny.

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Sponsored by Eurofins Lancaster Labs


Development Partners for Biopharma: Are you Getting What You Need?

Available Until Feb. 25, 2017

Your current contract laboratory and instrument provider may be familiar and comfortable, but, maintaining the status quo doesn’t lead to greater rewards. In fact, it often involves putting up with less-than-desired results. Join us in this web seminar to hear how Ajinomoto Althea develops unsurpassed solutions for biopharma companies, and how a team at Thermo Fisher Scientific has challenged the status quo to deliver uncompromised UHPLC.

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Sponsor: Thermo Fisher Scientific


Engineering the Mechanical Properties of Amorphous Spray-Dried Dispersions

Available Until Feb. 23, 2017

Capsugel Dosage Form Solutions will present a webinar discussing the aspect of engineering spray-dried dispersion properties, with a particular emphasis on the impact of atomization and drying rate on powder mechanical properties.

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Sponsor: Capsugel


Understanding Water Activity to Ensure Microbial Safety and Product Stability
Available until Jan. 27, 2017 


In this 60-minute webcast, experts will explain the concept of water activity and its relationship to the growth of microorganisms. Key regulatory guidance and compendial documents will be reviewed.

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Sponsor: Aqua Lab by Decagon


Comparing Performance of Gelatin Capsules and the Next Generation of HPMC Capsules
Available until Jan. 19, 2017
New in-vivo data demonstrating the performance characteristics of the next generation of HPMC capsules and early research into HPMC’s role as a functional excipient.

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Sponsor: Capsugel


Best Practices for Effective Product Transfer
Available until Jan. 20, 2017

Considerations for preparing for the process transfer, ensuring equipment and materials consistency, and post-transfer activities will be discussed.

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Sponsor: Rottendorf Pharma


 

Optimizing M&A Integration for Customer Success: The CMO Perspective
Available until Oct. 29, 2016

Merger and acquisition (M&A) trends in the contract services and biopharma space are set to continue in the coming years. Although M&A at contract manufacturing organizations (CMOs) can be a stressful time for clients, customers should know that M&As offer various opportunities for continuous improvement and the service providers that go through M&A integration most frequently are likely to be among the best proponents of the process. Learn best practices in approaching integration planning. Find out why change management is vital during acquisitions and learn what you should be communicating during integrations and when you should be talking to the CMO.

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Sponsor: AMRI


Thermal Sintering for Controlled Drug Release of Hydrophilic Drugs
Available until Oct. 22, 2016

Proper drug release of high-dose hydrophilic drugs is a challenge for formulators since both the initial drug burst release, as well as the consequent sustained release, need to be controlled. Excipients can provide an answer to drug release challenges when their hydrophobic nature is coupled with thermal sintering. This approach intensifies the retardation of drug release by forming plastic matrices of high mechanical strength, which can withstand dose dumping and achieve controlled release. In this webcast, a formulation expert will discuss BASF's Kolliwax grades and their suitability for thermal sintering; describe how high-dose hydrophilic actives were selected to demonstrate the efficacy of thermal sintering (60-65% w/w) using Kolliwax grades; and present processing parameters to enable customers to reproduce controlled drug release of hydrophilic drugs using thermal sintering.

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Sponsor: BASF


Monoclonal Antibody Purification by Protein A Affinity and Hydroxyapatite Mixed Mode: Multi-Column Continuous Chromatography

Available until Oct. 7 2016

Join Tosoh Bioscience and Semba Biosciences for a discussion on the use of high capacity protein A and hydroxyapatite resins for mAb purification using a multi-column continuous chromatography process.

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Sponsor: Tosoh Bioscience


Calibration and Qualification of Laboratory Instruments in Accordance with GMP Requirements

Available until Oct. 6 2016

Calibration, qualification, and the right appropriate level of routine testing for laboratory instruments are critical to ensuring high-quality results and maintaining GMP and USP compliance. Understand the relationship between these factors to optimize testing and be prepared for audit.  

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Sponsor: Mettler Toledo


Establishing a Risk Management Plan for Compliance and Pharmacovigilance

Available until Sept. 23 2016


Risk Management Plans have become a cornerstone in the pharmacovigilance of new drugs. It was introduced to support a proactive approach in gaining knowledge on safety concerns through early planning of pharmacovigilance activities. In this webinar, EtQ and HighPoint Solutions will cover the regulations around the European Medicines Agency’s Risk Management Plan and also the FDA's Risk Evaluation and Mitigation Strategy.

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Sponsor: EtQ


Controlling Contamination in Biopharmaceutical Manufacturing
Available until Sept. 15, 2016

In this webcast, experts will review the sources of contamination, regulations and guidance documents on the control of potential contaminants in raw materials, and best practices to guard against the introduction of contaminants in the manufacturing process. The challenges of detecting contaminants, including mycoplasma, assay development, and testing practices will be discussed.

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Sponsored by SGS Life Science Services


Twin Screw Wet Granulation for Solubility Enhancement of Poorly Water-Soluble Drugs

Available unitl September 9, 2016

Poorly-soluble APIs present formulation and development challenges. Excipient selection and manufacturing process development are crucial. Continuous twin-screw granulation is gaining acceptance as a manufacturing technology to address issues presented by these APIs and offers high production capacity in a small footprint. Learn how to improve the solubility of poorly water-soluble active ingredient using twin-screw wet granulation and proper excipients.

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Sponsored by BASF


Innovative Tools for the Development and Manufacturing of Biotherapeutic Proteins

Available until July 30, 2016

 

The biopharmaceutical industry has seen ever increasing innovation over the past five years. Most notably, there has been an increase adoption of high-throughput process development (HTPD) and single-use technologies. Join our webinar to learn effective strategies to match product quality attributes for a biosimilar product and reduce process development timelines.

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Sponsored by Patheon


Successful Binding of Peroxide-Sensitive APIs
Available until July 7, 2016

In this live webinar, experts will showcase how to formulate a peroxide-sensitive drug using a binder that combines high binding strength with no peroxide formation at all.

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Sponsored by BASF


Capsule Filling: Manufacturing Efficiency and the Added Value of Technical Service
Available until June 30, 2016

As challenging new formulations are developed, how prepared is your team to optimize the formulation performance in encapsulation? This webinar will provide insight into improving productivity in the use of capsules for pharmaceutical products for both the formulator and supply chain. Capsule filling technologies, dosing options, excipients, capsule selection, and other factors will be discussed. An example from the field will illustrate encapsulation practices.

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Sponsored by Capsugel


Strategies to Accelerate Early Phase Clinical Trials
Available until June 30, 2016

 Learn about adaptive clinical trials, patient recruitment strategies, and advanced biomarker analysis tools designed that can accelerate drug development and clinical testing processes.

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Sponsored by SGS


Trends in Quality Agreements & Communications: A CMO Perspective
Available until June 23, 2016
 
This webinar, led by Milton Boyer, senior vice-president of drug product manufacturing at AMRI, will review and challenge the changing paradigms in the CMO­/drug sponsor relationship. It is clear that both CMOs and drug sponsors are being held responsible for the actions of the other. Responsibilities once thought to be clearly defined are changing, with new guidance and expectations revealed in 483s and FDA warning letters.

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Sponsored by AMRI


Addressing Formulation Needs With a Different Technology: Say "Hello" to Ion Exchange Resins
Available until June 24, 2016

Ion exchange resins have long been in the formulator’s toolkit, but only recently have they been used as excipients. Learn the value and benefits ion exchange resins bring to drug formulation challenges such as taste masking, abuse deterrence, controlled release, and more.

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Sponsored by Dow


Hydroxyapatite Separation of Monoclonal Antibodies and Antibody Fragments
Available until June 17, 2016

Join us for a discussion on the use of hydroxyapatite in mAb and mAb fragment purification processes.

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Sponsored by Tosoh Bioscience LLC


Sample Preparation Technologies for Improved Peptide Quantitation Workflow
Available until June 16, 2016

Peptide quantitative analysis requires workflows that deliver high levels of data quality while balancing the needs of sample throughput and regulatory compliance. Learn how advances in sample preparation can enable greater speed, reproducibility, and improved data quality.

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Sponsored by Thermo Fisher Scientific


Controlling the Physical Properties and Performance of Semi-solid Formulations Through Excipient Selection
Available until June 10, 2016

Are you developing new topical products to meet specific design criteria? Are you seeking to replicate the performance of a reference product? In either case, you can achieve your goals by intelligently employing your toolkit of excipients and exploiting knowledge of how they work on a fundamental level. BASF will introduce you to cases that demonstrate the functionality of their excipients and their use in solving problems or meeting design objectives.

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Sponsored by BASF


Solubility Enhancement: Solutions using Predictive Analytics & Molecular Modeling
Available until June 4, 2016

Learn about a novel, systematic methodology to accelerate solubilization of poorly soluble molecules and speed formulation optimization and process development. Understand how molecular modeling can be used enhance the predictability of solubilization and overcome poor bioavailability.

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Sponsored by Patheon


Building the Future: Using Simulation Effectively
Available until June 3, 2016

Join our free webinar for a case study on the handling of complex manufacturing expansion projects, with insight on simulation and visualization tools, innovations for manufacturing of parenterals, effective team building, and more.

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Sponsored by Baxter


The Importance of Data Integrity in a GXP Regulated Laboratory
Available until May 27, 2016

With increased inspection scrutiny on data integrity, it is critical that managers and scientists in GXP regulated laboratories understand the current regulatory position. Discover the criteria for data integrity and learn how to assess and improve laboratory data management processes to ensure compliance with current regulations. 

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Sponsored by Mettler Toledo


Stability Assessment for Shipment of API and Drug Products
Available until May 21, 2016

Increasing requests from regulatory agencies have focused on evaluation of APIs and drug products during shipment. However, little guidance has been provided on how to address these concerns. This webinar will address these questions and explore approaches to assessing stability of biologic APIs and small molecule drug products throughout shipment.

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Sponsored by Patheon


Practical Guidance for Successful Mammalian Cell Banking & Cell Line Characterization
Available until May 14, 2016

Join this informative webinar, presented by the team at Eurofins Lancaster Laboratories, to learn about the various aspects of cell banking and cell line characterization, including GMP production master and working cell banks, GMP non-production (e.g. bioassay) master and working cell banks, R&D cell banks or banking for end of production cells.

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Sponsored by Eurofins Lancaster Laboratories


Practical Implementation of the New Elemental Impurities Guidelines
Available until May 5, 2016

The new ICH Q3D Guideline for Elemental Impurities has initiated reviews and changes in quality testing programs in bio/pharmaceutical companies around the world. Companies need to assess the risks of potential elemental impurities in their process and materials streams. In this webcast, experts review the requirements of elemental impurities guidelines, practical recommendations to address implementation challenges, and key considerations for analytical testing programs. 

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Sponsored by SGS Life Science Services


Applying Water Activity to Pharmaceutical Products
Available until March 25, 2016

Learn basics of water activity and the role it plays in the chemical stability, microbial content, and physical properties of pharmaceutical products. Hear experts discuss compendial and regulatory requirements for water-activity determination, and practical applications of water activity in marketed pharmaceuticals.

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Sponsored by Decagon Devices


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