Webcasts - Pharmaceutical Technology

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Best Practices for Effective Environmental Monitoring Program in Bio/Pharmaceutical Production
Tuesday, April 22, 2014; 11 am-noon Eastern US time and Tuesday, April 29, 10:00-11:00 Central European time

Contamination poses a threat to process and product integrity, as well as patient safety. A comprehensive environmental monitoring program can ensure that manufacturing areas, cleanrooms, production equipment, and water and gas utilities are free of viable and non-viable contamination and meet regulatory requirements. In this webcast, learn about pertinent regulatory and quality standards, as well as best practices for establishing and maintaining an effective environmental monitoring program. Review measures for testing pharmaceutical water systems according to U.S. Pharmacopeial Convention (USP) water monograph as well as procedures to evaluate the purity of production gases.

Register free at www.pharmtech.com/emp
Sponsored by SGS Life Science Services


Practical Implications of the Lifecycle Approach to API Process Validation
May 15, 2014, 10 AM EDT

API process validation experts describe the different activities required during the process design and process qualification stages, as well as continued process verification throughout the life of the commercial process. Hear about key requirements for API process validation including regulatory requirements, manufacturing conditions, data collection, testing to be performed, sampling plans, and analytical method validation.

Register free at www.pharmtech.com/processval
Sponsored by Regis Technologies Inc.


Life Cycle Management Opportunities In Softgel Technologies: Regulatory and Technological Aspects
Wednesday, May 21, 2014 at 11:00 AM EDT

Softgel expert, Kaspar van den Dries will talk about the opportunities for formulating products with softgel technologies for pediatric, adult and elderly population. Learn about registration of a generic chewable softgel for pediatric indication.

Register free at www.pharmtech.com/opportunities
Sponsored by Patheon


ON DEMAND WEBCASTS

Overcoming Challenges in the Development of Active Drug-Layered Formulations for Multiple Dosage Forms
Available through April 8, 2015

The development of active-drug-layered formulations can present many manufacturing and analytical challenges. In this webcast, experts will discuss development considerations for immediate-release dosage forms of a single drug entity or fixed-dose combination drugs and present case studies. An analytical scientist will provide insight on how to address the analytical challenges involved in the development of active-drug-layered formulations, especially those with multiple active ingredients. 

Register free at www.pharmtech.com/overcomingchallenges
Sponsored by Patheon


Meeting USP Good Storage and Distribution Practices in a Complex Supply Chain
Available through Apri 3, 2015

The latest revision of USP Chapter <1079>, Good Storage and Distribution Practices for Drug Products focuses on product quality through risk management, with an emphasis is on the use of a suite of quality management systems tools, including Good Documentation Practices, qualification and monitoring. Hear an overview of these changes, best practices to follow, and how the changes apply in the context of mapping and monitoring controlled temperature products.

Register now at www.pharmtech.com/storage
Sponsored by Vaisala


Increase Control over Quality Management Through Strong Supplier Relationships
Available through Apri 2, 2015

Understand the regulatory obligations of bio/pharmaceutical companies in a global, outsourced supply chain and challenges with building effective supplier relationships. Learn how a supplier quality management system should provide the ability to aggregate quality metrics in a consistent, measurable, normalized, and repeatable way.

Register free at www.pharmtech.com/relationships
Sponsored by Sparta Systems


Navigating the Analytical Development Challenges for Bioprocess Residuals and Impurities
Available through Apri 1, 2015

Tracking the clearance of host cell components and process additives residuals is an essential part of process development and characterization of biopharmaceuticals.
In this webinar, learn about challenges presented by residuals, regulatory expectations, analytical approaches for cell- and process-associated residuals, a platform method technology for residuals, and matrix effects.

Register free at www.pharmtech.com/navigating

Sponsored by Eurofins Lancaster Laboratories


Strategies for Successful Scale-up Using Quality by Design
Available through March 27, 2015

Successful scale-up from clinical-scale to commercial-scale production is imperative for realizing the market opportunities for a drug product. As pharmaceutical companies adopt Quality-by-Design (QbD), scalability is evermore challenging and complex. Realizing the benefits of QbD requires setting a foundation in development by identifying critical quality attributes (CQA) and critical process parameters (CPPs) and understanding how those CQAs and CPPs may need to be redefined with scale-up and related modifications in equipment, material attributes, or process changes. This 60-minute webcast will outline best practices for ensuring successful scale-up for manufacturing finished drug products by offering a systematic approach and technical case studies for implementing QbD through development to scale-up to commercial manufacture.

Register free at www.pharmtech.com/scaleup
Sponsored by DPT and Confab


Avoiding Out-of-Specification (OOS) and Aberrant Results: Weighing and Sample Prep
Available through March 26, 2015

Out-of-specification (OOS) and aberrant results are a big concern for analytical and QA/QC laboratories in the pharmaceutical industry. Accurate weighing and data integrity are essential in the preparation of analytical sample or standard solutions. Any error in these steps can have a profound impact on the product quality and the occurrence of OOS. In this 60-min webinar, learn how to improve weighing accuracy, minimize electrostatic effects, and produce traceable audit-proof data. Discover the benefits of gravimetric sample preparation, a state-of-the-art technique described in United States Pharmacopeia (USP) chapter <1251> "weighing on an analytical balance". Find out how to recognize the causes of error and variability in weighing and sample preparation and optimize the process.

Register free at www.pharmtech.com/avoid_oos
Sponsored by Mettler Toledo


Identifying, Analyzing, and Controlling Particles throughout the Biopharmaceutical Product Lifecycle
Available through March 25, 2015

Preformulation screening can identify potential problems and form the basis for long-term stability of biopharmaceutical drug products. One of the main challenges in the development of stable biopharmaceutical products is the control of aggregation and particulate formation. Review how particles can potentially develop through the life cycle of a drug, understand regulatory expectations, and assess analytical techniques available to assess protein aggregation and particulates for innovator drugs and biosimilars.

Register free at www.biopharminternational.com/particles
Sponsored by SGS Life Science Services


Best Testing Practices for Water Activity: A Risk Assessment Tool for Microbial Limits Testing and Stability Testing
Available through March 12, 2015

US Pharmacopeia (USP) Method <1112> Microbiological Attributes of Nonsterile Pharmaceutical Products—Application of Water Activity Determination outlines strategies based on water activity that can reduce the amount of microbial limit testing needed for drug products with lower water activities. Water activity not only provides the tool and rationale for reducing the frequency of microbial limit testing, it also aids in formulating naturally preserving systems and relates directly to a drug product's chemical and physical stability. This 60-minute webcast will examine the USP provisions for water-activity determination, best testing practices for water activity, and the role of water-activity determination as a risk-assessment tool in providing scientific justification for reducing microbial limit testing.

Register free at www.pharmtech.com/water
Sponsored by Decagon Devices


Best Practices for Preventing Metal Contamination of Pharmaceutical Products
Available through Jan. 22, 2015

Product quality is of the highest importance to pharmaceutical manufacturers, and the successful detection and control of contaminants are crucial. This webcast examines a comprehensive and best-practices approach for the control and prevention of metal contamination in pharmaceutical products. The process is a three-tiered approach that includes prevention activities, in-process control or removal, and detection. This approach involves: prevention measures as a key means for avoiding contamination; application of in-process controls to remove the presence of metal particles; and systems for the detection of metal contamination and monitoring controls.

Register free at www.pharmtech.com/ceia
Sponsored by CEIA


Optimizing CMO Selection for High-Potency Pharmaceutical Product Development and Manufacturing
Available through Jan. 15, 2015

High-potency manufacturing requires specialized facility capabilities, equipment selection, and manufacturing processes to achieve the desired levels of containment that meet occupational safety requirements. Selecting a contract manufacturing organization to handle your highly potent compound can be a time-consuming and difficult task. Often, much of the difficulty comes from not anticipating the information needs that a CMO requires and identifying the key technical and production capabilities required of a CMO partner is crucial for effective CMO selection and project execution. This webcast examines the definition/classification of potent compounds; types of toxicology information needed for preclinical and clinical development and commercial production; systems, processes, procedures and capabilities required for handling and manufacturing high-potency pharmaceuticals; and strategies for effective project management and execution.

Register free at www.pharmtech.com/highlypotent
Sponsored by Evonik Industries


Ensuring USP Compliance with Revised Chapters on Weighing
Sponsor by Mettler Toledo
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Available through Dec. 3, 2014

Complex Parenteral Formulations for the Delivery of Peptides, Proteins, Nucleic Acids and Small Molecules
Sponsor by Evonik Industries
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Available through Nov. 21, 2014

Ensuring Preparedness for Regulatory Inspections
Sponsor by EMC Corporation
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Available through Nov. 7, 2014

Achieving Regulatory Compliance When Moving to ICP-MS for Elemental Impurity Analysis
Sponsor by Agilent Technologies
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Available through Nov. 6, 2014

Implementing Risk Management for Regulatory Compliance
Sponsor by ETQ
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Available through Nov. 5, 2014

Keys to Regulatory Compliance in the Pharmaceutical Supply Chain
Sponsored by Aptean
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Available through Oct. 17, 2014

Optimizing Bioavailability: Enhancing Pharmaceutical Productivity
Sponsored by BASF and Catalent Pharma Solutions
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Available through Oct. 15, 2014

Optimizing Microbial Quality Control Testing
Sponsored by Rapid Micro Biosystems
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Available through Oct. 1, 2014

Meeting Regulatory and Technical Requirements for Organic Impurity Analysis
Sponsored by SGS Life Science Services
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Available through Sept. 24, 2014

Safe Automated Weighing of Potent Compounds in the Pharmaceutical Industry
Sponsored by Mettler Toledo
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Available through Sept. 17, 2014

Containment Strategies in High-Potency Manufacturing
Sponsored by Kimberly-Clark Professional
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Available through Sept. 12, 2014

Application of Engineering Solutions to Solve Challenges in Pharmaceutical Processing: Case Studies from Development to Production Scale
Sponsored by Patheon
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Available through Sept. 11, 2014

Achieving GMP Compliance for Environmental Monitoring Systems
Sponsored by Vaisala
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Available through Aug. 21, 2014

Overcoming Challenges in Development of Oral Enteric and Controlled-Release Dosage Forms
Sponsored by Patheon
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Available through July 18, 2014

Risk-Mitigation Strategies for API Manufacturing in Emerging Markets
Sponsored by Neuland
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Available through June 19, 2014

Achieving Raw-Material Transparency in the Pharmaceutical/ Biopharmaceutical Supply ChainEfficiency
Sponsored by SAFC
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Available through June 18, 2014

Ensuring Global Regulatory Compliance for Product Registrations: Strategies for Risk Reduction and Operational Efficiency
Sponsored by Sparta
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Available through June 11, 2014

Regulatory, Biosafety, and Clinical Considerations for Vaccine Development
Sponsored by SGS Life Science Services
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Available through June 11, 2014

Cleaning Validation: Science, Risk, and Novel Approaches to Testing
Sponsored by Patheon
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Available through June 4, 2014

Risk Mitigation for Alcohol-Dose Dumping in Controlled Release Forms
Sponsored by FMC
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Available through May 23, 2014

Minimizing Out-of-Specification (OOS) Errors Using a Risk-based Gravimetric Approach
Sponsored by Mettler Toledo
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Available through May 22, 2014

Trends in Safe Handling of Potent Compounds in Pharmaceutical Manufacturing Processes
Sponsored by Patheon
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Available through May 15, 2014

New Strategies for Evaluating BioPharmaceutical Stability
Sponsored by ABC Labs
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Available through May 9, 2014

A Pragmatic Application of QbD: Turning Theory into Tangible Success
Sponsored by Patheon
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Available through May 2, 2014

Questions? Contact Sara Barschdorf

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Which of the following business challenge poses the greatest threat to your company?
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Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
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