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Establishing a Culture of Compliance
Ron Johnson, President of Becker & Associates Consulting, an NSF International Company, discusses the critical need for establishing a “culture of compliance” for companies seeking to prevent, or remediate, regulatory compliance violations. An organization’s culture is shaped by its values, principles and beliefs. These are established at the top of the organization and must be effectively communicated throughout the enterprise. Training of employees and management is one of several critical elements to the establishment of a culture of quality.
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The Evolution and Implementation of Intelligent Sensors into BioTech and Pharmaceutical Markets
This podcast will discuss the evolution and implementation of intelligent sensors into the BioTech and Pharmaceutical markets, discussing key points like implementation, advantages, and process of information being received.
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Realizing opportunities in caregiver-intensive settings through transdermal drug delivery
With a growing portion of population affected by chronic conditions, the burden on health care providers, patients and their caregivers continues to increase. Selecting a patient and caregiver-focused drug delivery method is an effective solution to meet these needs.
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Vetter´s Development Service Doubles Revenues and Grows Capabilities
Join Sara Barschdorf and Dr. Paul Nelles, Vice President Vetter Development Service, as they discuss the increase in customer demand for development support of complex compounds. Listen to hear tips and suggestions that will help you choose the best CDMO to support your parenteral drug project.
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Topical Drug Development for Dermatology Products
Very few new drugs have been approved for the treatment of dermatology diseases. The challenges and unique requirements of dermatology drug development will be discussed including regulatory, preclinical and clinical issues and strategies for successful product development. Rapid early proof-of-concept, life cycle management and 505b2 approaches will be discussed, as well as risk management and minimization of attrition.
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The Awesome Power of Virtual “Quality” in a Regulated Environment
Pharmaceutical Technology interviews Troy Fugate, Vice President of Compliance Insight on virtual quality in a regulated environment.
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Navigating Transdermal Outsourcing: Points to consider when seeking a Transdermal Drug Delivery manufacturing partner.
Considerations when choosing a transdermal manufacturing partner.
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Breathe easy: Expert advice for selecting the right manufacturing partner for inhalation drug delivery
How pharmaceutical companies go about selecting a manufacturing partner for their inhalation drug delivery products.
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Asset Accuracy: Know What You Have and What It’s Worth
Pharm Tech interviews Christopher Kinzie, the Director of Appraisal and Valuation Services for EquipNet, Inc. Chris outlines how pharmaceutical companies use appraisal and valuation services to capitalize on their assets and reduce the risk of liability.
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Single-Use Pumps in Biologicals Production
Biologicals represent the new frontier in drug production. In order to optimize biological production, drug manufacturers must utilize pumps that are compatible with the filtering systems used in the production process and operate in a way that doesn't damage the biological matter. This means incorporating single-use pumps that can deliver reliable low-shear, low-slip, low-temperature, low-pulsation flow rates through specialized filtration equipment such as tangential flow filters, chromatography columns and centrifuges. Single-use positive displacement four-piston diaphragm pumps from Quattroflow™ have been proven to be the best choice for use in all varieties of critical biological-production and -handling applications.
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Drug Delivery Insights
Kurt Nielsen, PhD and senior vice-president, innovation and growth, Catalent Pharma Solutions, discusses strategies to resolve bioavailability and solubility challenges with Patricia Van Arnum, executive editor of Pharmaceutical Technology and Pharmaceutical Technology Europe (Posted April 2012).
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What You Should Know About Lean Six Sigma Initiatives
Lean Six Sigma as a means of continuous process improvement has been deployed by many companies with mixed results. In this podcast, Compliance Insight’s James C. Webber lays out some critical success factors, and failure modes, important to consider to ensure your initiative gets the expected results.
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DCAT President Discusses Industry Trends and Association Activities
As the industry readies for DCAT Week, which is being held this month March 12-March 15th, Patricia Van Arnum, executive editor of Pharmaceutical Technology and Pharmaceutical Technology Europe, speaks with Joan Connolly, president of the Drug, Chemical and Associated Technologies Association (DCAT) and principal with Connovan Consulting, to gain a perspective on industry trends affecting the pharmaceutical supply chain and the key goals and activities of the association. (Posted March 2012).
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Informex Roundup
In this podcast on Informex, which was held Feb. 14–17, in New Orleans, Patricia Van Arnum, executive editor of Pharmaceutical Technology and Pharmaceutical Technology Europe, speaks with Mike Feighery, sales manager of Informex with UBM Live and Caitlin Devlin, Informex marketing manager at UBM Live, to discuss the show. (Posted March 2012).
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Process Validation for Sterile Manufacturing
This podcast discusses the 2011 FDA Guidance for the Industry, Process Validation: General Principles and Practices, and the impact the guidance has for biotechnology and pharmaceutical companies performing sterile manufacturing process validation. The three stages of process validation in the guidance and their implications for sterile manufacturing are discussed.
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Pharmaceutical Forensics for Identification and Source Determination of Particulate Contamination in a Parenteral Manufacturing Process
In this podcast David Exline, Senior V.P at Gateway Analytical discusses the pharmaceutical forensic approach that Gateway Analytical takes to determine the source of a contaminant when found in the parenteral manufacturing process.
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Baseline Guide® Risk-based Manufacture of Pharmaceutical Products (Risk-MaPP) – Approach and Experience
We will discuss how Oso BioPharmaceuticals has successfully implemented a scientific, risk-based approach to handling hazardous compounds, how it has impacted their clients, and the reaction of regulatory bodies. OsoBio will share how implementation of this approach has affected its business as well as its processes.
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Technical Perspectives: Antibody Drug Conjugates
Grant E. Boldt, PhD, director of European business development for SAFC, discusses manufacturing considerations in producing antibody drug conjugates with Patricia Van Arnum, executive editor of Pharmaceutical Technology.
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Pfizer Outlines its Supply Strategy
John Kelly, vice-president of strategy and transitioning sites for Pfizer Global Supply, discusses the company's manufacturing and supply strategy and network with Patricia Van Arnum, senior editor of Pharmaceutical Technology (Posted November 2011).
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Perspectives from CPhI Worldwide
Patricia Van Arnum, senior editor of Pharmaceutical Technology, discusses strategies in optimizing API syntheses and manufacturing. Participants include Jan-Olav Henck, PhD, chief scientific officer at Aptuit, Fred Fleitz, senior manager of process R&D with Cambridge Major Laboratories, and Roger McDonald, director of business development with Cambridge Major Laboratories. Also, Annemieke Timmers, CPhI brand director with UBM, discusses CPhI Worldwide, which was held in Frankfurt in October 2011 and other CPhI events (Posted November 2011).
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AAPS 2011 Scientific Award Winners
Student winners provide a detailed look at their research through PowerPoint presentations and self-recorded podcasts (Posted October 2011).
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US Pharmacopeia Leaders Discuss the Future of Biologics and Biosimilars
Senior Managing Editor Angie Drakulich interviews leaders and speakers from the US Pharmacopeia 2011 Science and Standards Symposium on emerging topics in biologics, including biosimilars, new USP monoclonal antibody chapters, FDA approvals, and more. Featuring USP's Tina Morris and Matthew van Hook, and Engel & Novitt's Gillian Woollett (Posted October 2011).
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Vetter´s Chicago Facility Fully Operational
Peter Soelkner speaks with us about Vetter’s new fully operational site located in Chicago at the Illinois Science + Technology Park in Skokie (Posted October 2011).
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CPhI Show Daily Podcast Series
European Editor, Rich Whitworth interviews key organizational leaders to explore new product launches, developments and technical highlights to be found at the 2011 CPhI Worldwide and ICSE exhibition (Posted October 2011).
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The Case for Upgrading existing HPLC Assays to UPLC
Eric Hill of Impact Analytical discusses the emergence new analytical technologies, specifically UPLC. He outlines the advantages of converting existing HPLC assays to UPLC, including both increased performance and cost savings. With minimal upfront investment, the long term gains are significant.
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Step-by-Step Validation for Bio/Pharmaceuticals: Meeting New Regulatory Expectations
FDA published the long-awaited Process Validation: General Principles and Practices guidance in January 2011. Industry has since been scrambling to make changes to its validation plans and programs to comply with new regulatory expectations. This 3-part podcast series provides listeners with best practices as well as practical insight into implementation of and regulatory expectations for a start-to-finish validation plan in the bio/pharmaceutical manufacturing industry (Posted October 2011).
Part 1 focuses on how to prepare a process validation plan; Part 2 addresses how to implement changes to current process validation programs based on the new FDA Process Validation guidance; and Part 3 covers how to meet common challenges when performing a cleaning validation program for bio/pharmaceuticals, including practices tied to the new guidance. Risk-based approaches and related international guidelines will be discussed.
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Considerations in ophthalmic formulation development for various ocular diseases
Dr. Yunik Chang shares ophthalmic formulation technology with scientists and formulators who are interested in developing eye-care products.
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PDA-FDA 2011 Joint Regulatory Conference Promo
Susan Schniepp, co-chair of this year's meeting, and Angie Drakulich, sr. managing editor of Pharmaceutical Technology, discuss what to expect at the 2011 PDA-FDA Joint Regulatory Conference, featuring a focus on FDA enforcement, compliance, and industry best practice. Audoi (Posted September 2011).
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Pharma Faceoff: Should Pharma Invest in R&D or Search for External Drug Candidates?
Join Shire's Renee Cohen, Sanofi's Ray Jupp, Deutsche Bank's Barbara Ryan, Ken Kaitin of Tufts University, and Charlotte Sibley as they debate how pharma can find new drug candidates and refill the pipeline. Audio and Video.
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Pharma Faceoff: Debate Vermont’s Data Mining Law
Physician privacy vs. Rep Free Speech: Before the Supreme Court decides Sorrell v. IMS Health, find out what’s at stake. Jody Fisher, vice-president of marketing for SDI and Frank Pasquale, the Schering-Plough Professor in Health Care Regulation and Enforcement at Seton Hall Law School, face off in this episode of Pharma Faceoff. Audio and Video.
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A Conversation with NIH's Francis S. Collins
Sr. Managing Editor Angie Drakluich talks with Dr. Collins about NIH's efforts to improve global healthcare, including an update on the human genome project, a focus on infectious and rare diseases in the developing world, and R&D grants for small businesse (Posted June 2011)s.
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ExcipientFest/IPEC Speakers Roundtables 2011
Sr. Managing Editor Angie Drakulich moderates live roundtables on excipient functionality and continuous manufacturing featuring speakers from FDA, USP, industry, and academi (Posted May 2011).
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A Conversation with Jim Greenwood
Editorial Director Michelle Hoffman talks with BIO President and CEO Jim Greenwood about innovation and more.
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| PharmTech podcasts are developed and produced by Phamaceutical Technology, a division of Advanstar Communications, Inc., which is solely responsible for podcast content |
