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Amorphous Dispersion Drug Formulations: A Modern Simulation-Based Approach
Wednesday, Sept. 07, 2016 at 11:00 AM EDT

Nearly 75% of drugs in development have solubility challenges which often leads to failure in clinical trials. Fortunately, by addressing solubility earlier in a development program, timelines can be shortened and risks can be mitigated.

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Sponsored by Patheon

Understanding the Relationship between Critical Quality Attributes and the Microstructure of Topical Semi-Solid Formulations
Thursday, September 8, 2016 at 11 am EDT | 10 am CDT | 8 am PDT

R&D teams developing topical semi-solid dermatology products can gain an understanding of the key factors that influence the formation of the complex assemblage of microstructures that compose the Q3, as defined by the arrangement of matter in a formulation, as well as how the microstructure influences the critical quality and performance attributes of the final product.

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Sponsored by BASF

Sustained-Release Formulation: Overcoming Key Challenges Like Alcohol-Induced Dose Dumping
Tuesday, September 13, 2016 at 11 am EDT | 10 am CDT | 8 am PDT

Sustained-release drugs offer patients benefits but present formulation challenges. In this webcast, experts review principles of sustained release formulation, as well as research conducted by the Free University of Berlin (Germany) and BASF, which investigated methods to successfully formulate sustained-release drugs that comply with regulatory requirements for alcohol-induced dose dumping.

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Sponsored by BASF

Best Practices for Effective Excipient Sourcing and Testing
North America Broadcast: Wednesday, Sept. 20, 2016 at 11:00 AM EDT
Europe Broadcast: Tuesday, Sept. 27, 2016 at 11:00am CEST

A complex supply chain and the potential for lot-to-lot variability makes sourcing and testing of excipients and ongoing challenge for drug manufacturers. In this webcast, experts will review measures drug manufacturers must take to comply with regulatory requirements; outline best practices for selecting and working with excipient suppliers; ad explain challenges with excipient testing programs including compendial method verification.

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Sponsored by SGS

New Trends in Hygienic Diaphragm Valves that Improve Reliability
Thursday, Sept. 22, 2016 at 11:00 AM EDT

The biopharmaceutical industry is under constant pressure to increase productivity, extend preventative maintenance intervals, and reduce overall operating costs—all without affecting product quality or purity. One area where performance can be improved is in the reliability of the facility’s hygienic diaphragm valves.

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Sponsored by ITT Engineered Valves

Enabling Formulation of Water-Soluble and Water-Insoluble Molecules Using a Lipophilic Salt Approach
Wednesday, Sept. 27, 2016 at 11:00 AM EDT

The use of lipophilic salt forms can give more APIs access to the well-established benefits of lipid formulations by overcoming certain product design constraints, such as the number and/or size of dosage unit. This webcast will describe an approach to prepare lipophilic salt forms for a range of APIs and formulate these in concentrated lipid formulations ready for oral delivery.

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Sponsor: Capsugel

Getting the Full Picture: Predicting Protein Stability Using Chemical and Thermal Denaturation
Wednesday, Sept. 28, 2016 at 11:00 AM EDT 

Biologic drug formulators require an understanding of the stability of proteins over time. In this web seminar, experts describe the use of nanoDSF, a label-free differential scanning fluorimetry method, for automated analysis of chemical and thermal unfolding of protein samples.

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Sponsor: NanoTemper Technologies

Employing a Lean Lab Approach to Optimize Lab Processes: Part 2 “Improve Productivity”
Tuesday, Oct. 11, 2016 at 11:00 AM EDT

If Lean Lab is properly implemented, the results can be impressive, delivering simpler workflows and processes, reduced lead times, and increased laboratory efficiency. In Part 2 of this webinar, experts will give advice on how to identify the actions that have the biggest potential impact on improving lab productivity and determine the next step toward a lean lab.  

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Sponsored by Mettler Toledo

Don't let the diluent be your weakest link in your drug product
North America and Europe Broadcast: Thursday, Oct. 13, 2016 at 10:00 AM EDT
Asia and Pacific Broadcast: Thursday, Oct. 13, 2016 at 3:00pm CST

Given today’s high cost of drug development and the increasing number of new drugs utilizing lyophilization, it is critical to choose the right diluent option and diluent program to support the efficacy of your drug product. Vetter experts Daniela Guttmann, Product and Service Manager, and Karin Kottig, Manager Contract Service Analytics, provide valuable insight on the choices of diluent programs available, and what factors you should consider to make the right choice for your injectable. 

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Sponsored by Vetter

Strategies for IND Filing Success
Friday, Oct. 21, 2016 at 11:00 AM EDT

For small pharma companies advancing a new API to the IND stage for the first time, the application process and compilation of the supporting CMC information can seem daunting. In this webcast, experts will demystify the process and provide practical guidelines and instructions for filing successfully.

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Sponsored by Regis Technologies, Inc.


The Advantages of a Employing a Lipid-Based Formulation Process in Early Development
Available until July 12, 2017

Lipid formulations are the most used dosage form for bioavailability improvement for approved drugs. Many early clinical development programs, however, are initiated with conventional formulation options despite the potential risk of product failure at a later stage. In this webinar, experts will explain the benefits of considering lipid formulation early in the development process and how a structured screening and development approach can assist in overcoming potential barriers associated with lipid formulations.

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Sponsored by Patheon

Compliance is Key: Solutions to Decrease the Likelihood of Receiving a Form 483
Available until June 23, 2017

What drives a pharmaceutical company to scrutinize an instrument manufacturer and every detail of the instrument during instrument qualification? The answer is simple, compliance. Every company that produces pharmaceutical products must guarantee a consistent quality product that meets regulated specifications for the entire product life cycle, from production to consumption. What happens when that compliance falls short? A review of inspection citations from 2015 can help you learn from the mistakes of others. Learn about solutions to decrease the likelihood of receiving an FDA Form 483.

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Sponsored by Anton Paar

Effective Extractables and Leachables Evaluation Programs for Single-Use Systems
Available until May 24, 2017

As single-use systems gain wider use in biopharmaceutical manufacturing, drug owners must understand the risk of potential contaminants from plastics interacting with the drug. Establishing clearly defined standards for acceptable testing protocols and has proven difficult. In this webcast learn about available guidance documents, a risk-based materials qualification process for extractables and leachables studies; and the value of standardized and custom testing protocols.

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Sponsor: SGS Life Science Services

Bio/Pharma in China: New Initiatives, New Opportunities
Part I: Available until May 18, 2017
Part 2: Available until May 19, 2017

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
Available until April 27, 2017

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"

Available until April 26, 2017

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

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: Thermo 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

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