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NIR to the Rescue: Production Efficiency and Cost Savings for Pharma
August 13th 2020Near infrared (NIR) spectroscopy to the rescue: See how this vital process analytical technology tool can improve efficiency and cut costs in your pharmaceutical QC processes. Live: Wednesday, Sept. 9, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Sept. 9, 2021
Discover Functional Film Coating Formulations for an Easy and Fast Coating Process of SODFs
August 12th 2020What are the reasons for functional film coating of solid oral dosage forms? How do polymers influence the release of active ingredients in a tablet coating? Abderraouf Allia uses many practical examples and different formulations to show what needs to be taken into account during formulation. Participate in this webcast and learn how ready-to-use film coating systems can simplify the coating and formulation process. Live: Wednesday, Sept. 16, 2020 at 10 am EDT | 9am CDT | 3pm BST | 4pm CEST On demand available after airing until Sept. 16, 2021
The Ever-Changing World of Extractables and Leachables
August 12th 2020Join global industry and regulatory experts as they discuss current E&L hot topics on pharmaceuticals, biopharmaceuticals and medical devices. Live: Wednesday, Sept. 9, 2020 at 9am EDT | 2pm BST | 3pm CEST On demand available after final airing until Sept. 9, 2021
Gene Therapy Development: From Methods to GMP Testing
August 5th 2020The molecular complexity, size, and higher-order structure of gene therapies create a unique challenge for pharmaceutical development. This webcast will provide insights into characterizing viral and non-viral gene therapies to ensure quality. Live: Thursday, Aug. 20, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Aug. 20, 2021
Manufacturing amorphous solid dispersions by spray-drying: scale-up approaches
August 4th 2020This webcast focuses on manufacturing aspects of amorphous spray-dried dispersions to enable successful scale-up and optimization of the process. An overview of spray drying and typical scale-up challenges will be presented along with a robust process development strategy to ensure critical-to-quality attributes are maintained. Tools and methodologies that enable rapid scale-up that is right the first time from clinical to commercial scale will also be highlighted. Live: Tuesday, Aug. 4, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Aug. 4, 2021 Register free
Engineering Approaches to Respiratory Drug Delivery: Mannitol Case Study
July 30th 2020If you have a new compound for respiratory drug delivery, what particle engineering approach should you take? This webinar will explore both micronization and spray drying approaches in relation to product performance of the inhaled drug product. Live: Thursday, Jul. 30, 2020 at 11am EDT | 8am PDT | 4pm GMT | 5pm CEST On demand available after airing until Jul. 30, 2021 Register free
Editors’ Series: Cell and Gene Therapies: Laying the Foundation for a New Supply Chain
July 29th 2020Existing biopharma supply chain practices must evolve to meet the needs of personalized therapies, particularly for autologous treatments. Force fitting manual processes will no longer work. Hear about lessons learned in a pioneering “vein to vein” pilot program that aims to establish new rules for data management and exchange, scheduling, and automating workflow and supply chain practices for novel and complex processes. Live: Wednesday, Jul. 29, 2020, at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On Demand: available after airing until Jul. 29, 2021 Register free
Editors’ Series: Overcoming Commercialization Challenges for Cell Therapies and Gene Therapies
July 28th 2020The complexities of producing cell therapies and gene therapies are testing established biomanufacturing practices and the companies engaged in producing the treatment. Join this webcast to hear about the technical and regulatory hurdles associated with development and manufacturing steps, and strategies and solutions to facilitate development through commercialization. Live: Tuesday, Jul. 28, 2020, at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On Demand: available after airing until Jul. 28, 2021 Register free
Best Practices for Meeting and Exceeding Regulatory Standards in Primary Packaging USP and
July 22nd 2020Interested in learning more about the regulatory requirements for elastomeric components in parenteral drug packaging? Sign up for the July 22 webcast on “Best Practices for Meeting and Exceeding Regulatory Standards in Primary Packaging USP and ” . This webcast is part of a series focusing on “The Path to Patient Safety – Addressing Industry Concerns and Solutions for Primary Packaging Component Selection.” Live: Part II: Wednesday, Jul. 22, 2020 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST On demand available after airing until Jul. 22, 2021 Register free
Effective Imaging for Identification and Sizing API Domains
July 21st 2020Combining FTIR and Raman spectroscopy provides the insight needed to ensure appropriate distribution and concentration of APIs within tablets. Watch this webcast to learn more. Live: Tuesday, Jul. 21, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after final airing Jul. 21, 2021 Register free
Expedite Regulated Documents in the Era of COVID-19: From Development to Trials and Manufacturing
July 15th 2020Technology is more critical than ever to help you keep your clinical trials on track during the era of COVID-19. Gain best practices about how to empower your remote workforce, get critical regulated documents electronically signed compliantly, and to create a safe and flexible remote patient-centric experience. Live: Wednesday, Jul. 15, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Jul. 15, 2021. Register free
How to Choose the Right Approach to Enhance Drug Solubility
June 25th 2020What is the correct approach for formulation development of poorly soluble NCEs? Dr. Umesh Barabde, director and operations head, Pharmaceutical Development Services, and Dr. Vishakh Kharat, director, analytical research, Pharmaceutical Development Services, both at Piramal Pharma Solutions discuss classic and specialized techniques to enhance solubility. Live: Thursday, Jun. 25, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after final airing Jun. 25, 2021 Register free
Dry Powder Inhalers: Key Considerations for Combination Product Development
June 24th 2020Dry powder inhalers (DPIs) are an important delivery technology for inhaled medicines in both respiratory and non-respiratory disease areas. Andreas Meliniotis, director of device development at Vectura, helps navigate the complex area of DPI product development and highlights the key considerations for both novel- and generic-drug programs. Live: Wednesday, Jun. 24, 2020 at 11am EDT |8am PDT |4pm BST |5pm CEST On demand available after final airing Jun. 24, 2021 Register free
Instrument Systems Take on Burden of Compliance
June 23rd 2020Want to be sure your systems and processes are compliant? Learn how two enable 21 CFR Part 11 in the lab with compliant workflows and consistent testing. Be confident in your analyses! Live: Tuesday, Jun. 23, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after final airing Jun. 23, 2021 Register free
Specialized Clinical Services for Complex Clinical Studies
June 23rd 2020This webinar will review Lonza’s integrated clinical supply services inclusive of manufacturing, primary and secondary packaging, kitting, and distribution with special emphasis on complex clinical studies and direct-to-patient shipping. Live: Tuesday, Jun. 23, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Jun. 23, 2021 Register free
How Digital Lab Assistants Can Improve GMP Data Integrity
June 22nd 2020Recording and tracking data streams in real-time, within GMP facilities is challenging. Learn how voice-powered digital lab assistants provide a solution by directly communicating with lab instruments and by automatically transcribing voice notes from staff to ensure data can be attributed to staff members via user identification, automatic timestamps, and electronic signatures. Live: Monday, Jun. 22, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Jun. 22, 2021 Register free
Preformulation of Small Molecule Drugs
June 18th 2020Preformulation studies play a significant role in developing approaches to analytical and formulation development based on the physicochemical properties of small-molecule pharmaceuticals. This webinar will provide insights into the preformulation phase of drug development and will illustrate common issues encountered. Live: Thursday, Jun. 18, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after final airing Jun. 18, 2021 Register free
Comprehensive Analysis into Disintegration Mechanisms: How Reliable Are Textbook Recommendations?
June 10th 2020When formulating a tablet, the solubility of the tablet matrix is often used as the sole criteria for disintegrant selection. Most formulators tend to select swelling-type disintegrants for insoluble matrices and wicking-type disintegrants for soluble matrices. This webcast will present an in-depth analysis of the effects of disintegration mechanisms, pH of test media, matrix plasticity, tablet hydrophobicity, and storage effects on the disintegration behavior. Live: Wednesday, Jun. 10, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Jun. 10, 2021 Register free
Discovery, Formulation, and Performance of Self-Emulsifying Drug Delivery Systems (SEDDS)
June 4th 2020Self-emulsifying drug delivery systems, or SEDDS, are arguably the most successful technology in the market today for taking poorly water-soluble APIs and turning them into bioavailable formulations. But where do you start? Learn about the physical chemistry of these systems, discuss testing options, and uncover 10 ready-to-use formulations to be used for your next project. Live: Thursday June 4, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST On Demand: available after airing until June 4, 2021 Register free
Excipient Science in Protecting Moisture Sensitive Drugs
June 3rd 2020Don’t just rely on packaging to protect drug products from moisture. In this webcast, discover how to develop more stable formulations by selecting the right excipients for use with moisture-sensitive drugs, and in doing so, reduce the risk of degradants and impurities. Live: Asia Pacific: Wednesday, Jun. 3, 2020 at 12pm IST | 2:30pm CST | 3:30pm JST US and Europe: Wednesday, Jun. 3, 2020 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST On demand available after airing until Jun. 3, 2021 Register free
Adopting a Data-Centric Quality Mindset
May 28th 2020In this exclusive webcast, MasterControl’s Product Management Director Sue Marchant examines why document dependency has become a hindrance to manufacturers and how companies can successfully chart a clear path to digital and data maturity. She also explains the drivers behind the industry’s shift away from document-centered quality management and explores trends relating to digital quality management. Live: Thursday, May 28, 2020 at 2pm EDT| 1pm CDT| 11am PDT On demand available after airing until May 28, 2021 Register free
Practical Considerations for Bringing Drug Candidates to Phase I Clinical Trial
May 27th 2020Looking for the right approach to advance your small molecule drug candidate? Philip Jones from MD Anderson Cancer Center shares thoughts on how to bring drug candidates to Phase I clinical trials. Live: Wednesday, May 27, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until May 27, 2021 Register free
Clinical to Commercialization: The Case for Design/Build Modular Facilities
May 27th 2020Learn how biopharmaceutical development and production can be more efficient by using modular technology. Live: Wednesday, May 27, 2020 at 2pm EDT | 1pm CDT | 11am PDT On demand available after airing until May 27, 2021 Register free
Editors’ Series: Strategies for Designing Adaptable, Resilient Bio/Pharma Facilities
May 26th 2020The COVID-19 pandemic should prompt bio/pharma facilities to assess how the potential spread of the virus may impact different areas of development and manufacturing facilities, employees, visitors, and product. Learn about strategies for evaluating practices at existing facilities and options for designing new facilities that can accommodate future needs, including flexibility requirements and any emerging threats. Live: Tuesday, May 26, 2020 at 2 pm EDT| 1pm CDT| 11am PDT On demand available after airing until May 26, 2021 Register free
Ensuring Integrity of Drug Formulation from Development to QC
May 21st 2020Learn how to reduce the number of steps and resources needed to assure chemical and structural integrity throughout drug development process. See where efficiencies can be gained in analytical methods development and transfer to QC and manufacturing while staying compliant with cGxP. Thursday, May 21, 2020 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST On demand available after final airing May 21, 2021 Register free