On-demand, concise tutorials on the fundamental concepts of pharmaceutical manufacturing, process
development, quality control and compliance brought to you by Pharma Manufacturing.
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Aseptic Processing
The Future of Blow-Fill-Seal Innovation in the Pharmaceutical Industry
Recent innovation in Blow-Fill-Seal technology means exciting new opportunities in biotech products and vaccines.
Presented by: Megan Johnson, Nephron Pharmaceuticals
Length: 14:18, 18 slides
Sponsor: Rommelag
Aseptic Processing: Origins to Current Day Technology
Understanding the history of aseptic manufacturing helps us to better understand the correct choices today. This presentation includes:
• A pictorial history and technology evolution of aseptic processing
• Personnel’s role in contamination
• Making the best choices for today and for tomorrow
Presented by: James Agalloco, Agalloco & Associates
Length: 16:09, 29 slides
Sponsor: Central Research Laboratories
Creating a Robust Control System in Modular/Skidded Systems
A modular skidded system is commonly used in food, pharma and biotech. If you're thinking about utilizing this approach in an upcoming project, this presentation discusses the benefits you can expect to realize, lays out the typical project steps and how partner companies work together, and provides ideas for successful execution.
Presented by: Brian Gehrke, Exec VP, A&P Process Systems Corp.
Length: 8:21, 20 slides
Sponsor: Festo
Pharma lab monitoring 101 NEW!
Safeguarding valuable scientific equipment and assets from deviations in ambient conditions 24 hours a day, 7 days a week is challenging. This Fundamentals Series program will highlight what needs to be monitored, as well as the common challenges faced in lab monitoring.
Topics covered:
• How monitoring has adapted to recent trends and shifts towards biopharmaceuticals in the industry
• Three areas of lab monitoring: lab equipment, lab environment, general facility
• Common monitoring challenge
Presented by: Karen Langhauser, Chief Content Director
Length: 7:45
Sponsor: XiltriX North America
The Drug Supply Chain Security Act Explained
This Fundamentals Series program offers a high level look at the Drug Supply Chain Security Act (DSCSA), including a detailed breakdown of the contents of this newly-signed law. This presentation offers valuable insight into:
• Necessary FDA deliverables • Implementation timelines
• Verification challenges • Lot-based pedigree system requirements
• Transaction information, history and statements • Serialization requirements
Presented by: Dirk Rodgers, RxTrace.com
Length: 22:19 sec, 26 slides
Sponsor: Cognex
Paperless Lab Fundamentals Presentation
Michael Gannon, CEO of Orbis Systems presents the objectives and benefits of a lean or paperless lab: transaction reduction, error elimination and reduction of processing, risk and overhead costs.
Presented by: Michael Gannon, CEO of Orbis Systems
Length: 21:51, 28 slides
Sponsor: Thermo Scientific
Calibration for Compliance
• What is calibration & why is it so important to pharmaceutical manufacturers?
• Managing changing procedures & standards
• Creating a chain of traceability • Creating calibration guidelines
Presented by: W. Rodney Perkins, VP, PCI
Length: 8:30, 16 slides
Sponsor: beamex
Cold Chain Fundamentals
This Fundamentals Series presentation will discuss:
• An overview of the Cold Chain
• Responsibilities, regulations, risks and pitfalls of the Cold Chain
• Storage and transportation of temperature sensitive materials
• An outline of factors critical to success
• Guidance and regulatory resources
Presented by: Hedley Rees, Managing Consultant, PharmaFlow
Length: 33:19, 24 slides
Sponsor: Vaisala
Data Integrity Issues in Regulated GxP Labs
Data integrity is not just confined to emerging markets -- it is a global issue. This Fundamentals Series presentation will provide: An introduction to data integrity; Definitions of data integrity; Criteria to ensure data integrity in lab records; Discussion of GxP regulations and guidance for data integrity; and 10 most common data integrity problems and how to resolve them
Presented by: Dr. Bob McDowall and Trish Meek
Length: 36:39, 32 slides
Sponsored: Thermo Fisher Scientific
Rapid and Alternative Microbial Testing Methods
Overview of the testing platforms available, the benefits of each and thoughts to aid in the decision making process.
Presented by: Kevin Jensen, Lab Manager, Nelson Laboratories
Length: 33:25, 25 slides
Sponsor: Rapid Micro Biosystems
Quality Risk Management: An Overview of ICH/FDA Q9, Including Tools & Techniques for Success
Principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. These include development, manufacturing, distribution, inspection, and submission/review processes throughout the lifecycle of drug substances, drug products, biological and biotechnological products (including the use of raw materials, solvents, excipients, packaging and labeling materials in drug products, biological and biotechnological products.
Presented by: Tye Spillum, Spillum Associates
Length: 28:13, 26 slides
Sponsor: EtQ
Fundamentals of Successful Vision Applications and Implementation Considerations
This Fundamentals Series program explains how successful vision applications and implementation considerations are accomplished in the pharmaceutical industry, including information on how to:
• Prevent counterfeiting
• Stop parallel trade and sale through unauthorized channels
• Minimize losses
• Achieve product safety
• Provide traceability and lot control
• Accomplish supply chain efficiency
Presented by: Starke Farley, Integro Technologies Corp
Length: 25:45, 35 slides
Sponsor: Cognex
Trends, Challenges and Analysis in Food and Beverage Industry
The survey revealed that there were four main pain points that food and beverage professionals are currently struggling with. These challenges are not new and with the imminent implementation of FSMA, they continue to be a focal point for food safety improvement plans. View this on-demand presentation now to learn how FSMA is driving some of these concerns, and how the industry is overcoming them.
Length: 20:39
Sponsor: Verse
Powder Flow: Identifying Powder’s Critical Quality Attributes & Relationship to Process Behavior
Powders are highly complex variable materials and are used in the manufacture of over 80% of products currently on the market. Flow properties relate to numerous processes so powder behavior will influence all sorts of key quality attributes of the finished product. This presentation addresses:
• Identifying powder characteristics & flow behavior
• Managing powder behavior
• Identifying powder Critical Quality Attributes (CQAs)
• Recent advances in measuring powder behavior
• Powder behavioral data facilitating QbD
Presented by: Dr. David Morton, Monash Institute of Pharmaceutical Science
Length: 33:07, 36 slides
Sponsor: freeman technology
Materials Identification Using Handheld Raman Technology
This presentation addresses current uses of raman technology particularly focusing on raw materials identification, standards and a regulatory overview. The presentation also provides an overview of the advantages of raman and offers two case studies.
Presented by: Art Hamfeldt
Length: 8:52, 22 slides
Sponsor: Rigaku Raman Technologies
The Importance of Particle Size Analysis in the Pharma Industry
• Regulatory guidance overview
• Particle size’s influence on product effectiveness and processing approaches
• Questions to ask before particle size determination
• Method development & validation
Presented by: William Kopesky, Particle Technology Labs
Length: 19:43, 27 slides
Sponsor: Malvern Instruments
