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Validation of Purified Water Systems
Igor Gorsky
150 Min
Product Id: 704272
This training program will dispel mistaken paradigms regarding the risk based approach to water system lifecycle. It will detail how to eliminate variability – the cause of most deviations. Attendees will learn how to capitalize on the advantages of online analytical instrumentation (chemical and microbiological rapid methods).
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Lyophilization Technology
Jerry Dalfors
80 Min
Product Id: 704028
This training program will discuss each of the critical aspects of freeze drying and the related effects of variables. The course will also discuss sublimation rate variability, heat transfer, loss of protein activity, and freezing effects on primary drying.
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Nutraceuticals/Dietary Supplements: FDA Regulatory Submission and Manufacturing Quality Requirements
Gretchen Bowker
60 Min
Product Id: 702741
This dietary supplements quality compliance training will review the FDA regulatory requirements for manufacturing and commercialization of dietary supplements. You will gain a complete understanding of FDA requirements for manufacturing of nutraceuticals, food drugs, and dietary supplements.
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Maintaining a Validated State – PV, PM and Statistics Associated with Current Regulation
Jerry Dalfors
80 Min
Product Id: 703637
This course will instruct attendees on establishing an approach to process control within each unit of operation to generate overall process control needed for validation. The webinar instructor, an FDA expert, will enumerate the importance of variation in enhancing a validated means of operation and the parameters that can cause variability. The Randomized Block statistical model will also be analyzed for effective validation.
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Driving Quality and Compliance in Drug Development Through the FDA End-of-Phase 2A Meeting
Roger Toothaker
60 Min
Product Id: 703214
This training on FDA compliance will provide the attendees with an understanding of FDA expectations regarding end-of-phase 2A meeting guidance. Attendees will learn the best practices to comply with the intent of the guidance and to achieve a higher quality outcome from the meeting.
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Product Complaint Investigations - The application of Lean Six Sigma methodology for U.S. FDA-Regulated Industries
Shahbaz Shahbazi,Ray Bandziulis
75 Min
Product Id: 702614
This webinar will discuss the use of Lean Six Sigma methodology for product complaint investigations and offer a standardized approach for FDA regulated life science companies to follow whenever product complaint investigations are needed.
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Quality Assurance and Good Manufacturing Practices (GMP) in Drug Production
Charles H Paul
90 Min
Product Id: 706936
Quality Assurance (QA) and Good Manufacturing Practices (GMP) play a critical role in ensuring the safety, efficacy, and quality of drugs during their production. In the pharmaceutical industry, QA refers to the systematic processes and procedures implemented to guarantee that drugs meet the established standards and regulatory requirements. GMP, on the other hand, encompasses a set of guidelines and regulations that govern the manufacturing, testing, and quality control of pharmaceutical products.
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GAMP®5, Second Edition and Alignment with FDA’s Draft Guidance for Computer Software Assurance (CSA)
Carolyn Troiano
90 Min
Product Id: 706932
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
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US FDA Requirements for Medical Products Labeling / UDI
John E Lincoln
90 Min
Product Id: 706969
The U.S. FDA has several requirement for the labeling of medical products. The key requirements are in 21 CFR 801.
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The GLPs and Analytical Test Methods Validation
John E Lincoln
90 Min
Product Id: 706978
Both the U.S. FDA and EU's MDR expect documented risk-based device test method and design V&V under the GLPs, et al
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Integrating Production Equipment, Processes, Systems and Procedures
John E Lincoln
90 Min
Product Id: 706956
Both the U.S. FDA and EU's MDR expect documented risk-based equipment, process,systems and procedures development, integration and maintenance.
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Lean Manufacturing For U.S. FDA-Regulated Industries
John E Lincoln
90 Min
Product Id: 706960
New and Realistic Lean Manufacturing can be a key to company success, by incorporating basic lean principles, while addressing FDA / CGMP requirements.
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Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA
Carolyn Troiano
90 Min
Product Id: 706930
We will discuss the importance of complying with FDA requirements for validation of systems using technologies that have been emerging for the past couple of decades. While FDA is planning to overhaul their own infrastructure to gain efficiencies, they are also encouraging industry to take advantage of newer technology and systems. These include cloud-based systems, Software-as-a-Service (SaaS), artificial intelligence, and others.
We’ll talk about taking a risk-based approach to validation, and how to implement newer capabilities such as electronic records and electronic signatures. We’ll also cover the importance of meeting data integrity compliance.
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Clinical Trial Systems: The Trial Master File (TMF) and Electronic Trial Master File (eTMF)
Carolyn Troiano
90 Min
Product Id: 706938
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF). All of the data and documents supporting the planning, conduct and evaluation of a clinical trial must be of the highest integrity, which must be maintained through their entire life cycle. Computer System Validation will be discussed as a key methodology for meeting all of these requirements and assuring data/document integrity.
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Human Error and Documentation Practices in Good Laboratory Practices (GLP): Understanding the Criticality of Accurate and Complete Documentation in GLP
Charles H Paul
90 Min
Product Id: 706941
In today's rapidly evolving scientific landscape, the 90-minute webinar titled "Human Error and Documentation Practices in Good Laboratory Practices (GLP)" offers an essential exploration of the critical role that accurate and complete documentation plays in maintaining the integrity of research processes. Delving into the heart of Good Laboratory Practices (GLP), this enlightening session uncovers the intricate relationship between meticulous documentation and the reliability of scientific findings. Over the course of the webinar, attendees will gain a comprehensive understanding of the multifaceted challenges posed by human errors within laboratory environments. With real-world examples, the webinar illustrates the potential consequences of inadequate documentation, underscoring the significance of precise record-keeping in safeguarding data integrity, research reproducibility, and regulatory compliance. Attendees will also glean valuable insights into common documentation errors and pitfalls, as well as invaluable strategies for bolstering documentation practices. From proactive measures and standardized procedures to fostering a culture of clarity and collaboration, participants will leave equipped with the tools to elevate their documentation practices and contribute to the overall credibility of their scientific endeavors.
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Applying Lean Documents to a Project - how to create a project file, follow design controls, yet maintain a lean set of project documents
Jose Mora
60 Min
Product Id: 700358
Using the lean document approach, documents are written by the authors with the highest level of expertise, and information is presented in a simple, organized way This webinar explains the use of lean document principles and presents a step-by-step approach to creating a Design History File, a Device Master Record, and other key supporting documents
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Technology Transfer of a Pharmaceutical Manufacturing Process
Rodney E Thompson
60 Min
Product Id: 700247
This webinar will cover the essential aspects for the cGMP-compliant technology transfer of a pharmaceutical manufacturing process.
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Outsourcing analytical and pharmaceutical development
Michael Gamlen
60 Min
Product Id: 700231
This webinar is targeted at people responsible for outsourcing, and at contractors who wish to ensure they provide excellent services which will generate them repeat business.
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FDA's cGMPs for the 21st Century Initiative
Betty Jones
60 Min
Product Id: 700156
This presentation will provide and insiders view FDA’s path to restructuring its regulatory oversight of manufacturing quality that is based on quality systems and risk management approaches In 2002, FDA announced a significant new initiative, Current Good Manufacturing Practices (cGMPs) for the 21st Century intended to modernize FDA’s regulation of pharmaceutical quality and established a new regulatory framework for manufacturing.
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Challenges of an Effective Change Control Program
Kenneth Christie
Product Id: 704638
This training program will provide attendees with a better understanding of current Quality System Regulations (QSR) require companies to maintain qualified equipment, utilities and facilities in a state of control. When changes are made to these items, the change must be documented, explained as to what will be done and the items that may be impacted. This webinar will also highlight what is expected, what to include in procedures and address the challenges faced by industry in trying to establish an effective and manageable program.