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Process Validation Guidance Requirements, FDA, EU Annex 15; Qualification and Validation
Joy McElroy
4 hrs
Product Id: 704737
This training program will illustrate how these two different concepts are integrated (Phase 1, 2, and 3 vs. Stages 1, 2, and 3) and where do they merge. Attendees will learn if they exist independently of each other or do they complement each other to enhance, build and provide a product.
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CDISC Cloud Computing in the Pharmaceutical Industry: Paradigm Shift in Project Management, Analysis and Validation
Sunil Gupta
75 Min
Product Id: 704674
This training program will help you better manage projects and offer practical tools to understand data content and quality. Attendees will learn to apply validation methods to reduce time to validate clinical summary tables. Attendees will also learn to apply advanced SAS programming techniques to standardize and automate the validation process.
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Pharmaceutical Company Specific Records and Information Management Programs
Charlie Sodano
60 Min
Product Id: 704667
This training program will focus on creating a workable and effective records and information policy. It will also discuss establishing records and information management responsibilities, determining the locations of all information resources, planning long term archiving, and content and records management software considerations and options.
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Renovating Existing Manufacturing Space to Accommodate Aseptic Fill/Finish
Erich Bozenhardt
60 Min
Product Id: 704665
This training program will give you the foundational tools necessary to identify changes that need to be made while renovating existing manufacturing space, formulate a concise implementation plan that includes compliance protocols, and allows for continuous improvement.
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FDA Compliance and Laboratory Computer System Validation
Carolyn Troiano
60 Min
Product Id: 704660
Upon completion of this training program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, based on the System Development Life Cycle (SDLC) framework. They will have received the guidance on industry best practices necessary to develop a compliant and cost-effective validation program. They will understand the steps for validating laboratory systems, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs. Attendees will gain a good grasp of how to leverage these practices across all systems by creating a standardized program.
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Preventing Recalls and Product Liability Lawsuits - Current Trends and Causes
Randall Goodden
60 Min
Product Id: 703080
This webinar will highlight the current statistics and trends regarding product recalls, product liability lawsuits, and the causes of these economic disasters for manufacturing corporations. It will also identify all the areas of manufacturing management that are typically not being handled properly and contribute to such failures, from product development thru marketing, product testing, supplier selection and control, document management, contracts and agreements, manufacturing quality, and incident investigation.
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Combination Products - The FDA's New Codifications of the cGMP Requirements Applicable to Combination Products
Angela Dunston
120 Min
Product Id: 704623
This training program will analyze the general considerations for cGMP compliance and review the cGMP requirements in 21 CFR 4.4(b). The program will also discuss applications of cGMP requirements for specific types of combination products.
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Single-Use Systems and Technologies
Mark Trotter
90 Min
Product Id: 704609
This training program will examine the many facets of disposable bioprocessing systems that incorporate a wide scope of polymeric single-use products. Single-use disposable technologies, from upstream to downstream processes, will be reviewed as related to the use of polymeric devices. Specific attention will be given to the related applications used in the production of biopharmaceuticals and pharmaceuticals.
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FDA Vs Health Canada
Angela Dunston
60 Min
Product Id: 703970
This training program will elucidate the similarities and differences between the FDA and Health Canada promulgations of regulations impact preparation. The course will also offer a review of the background and history behind the FDA and Health Canada.
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Successful Deviation Investigations
Danielle DeLucy
60 Min
Product Id: 704596
This training program will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. This webinar will focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Attendees will learn how to identify and avoid potential pitfalls during deviation investigations.
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Best Practices in Being ‘On Call’ for FDA Submission Audits in the CDISC Programming Environment
Sunil Gupta
75 Min
Product Id: 704594
This training program will assist anyone directly or indirectly responsible for the creation, content or validation of SDTMs, ADaMs, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. It will help attendees in determining how well your company is positioned to defend your FDA submission.
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Creating FDA-compliant cGMP Training Program
Henry Urbach
60 Min
Product Id: 703401
This webinar will explain how to implement an effective and FDA compliant GMP training program. It will discuss regulatory requirements and expectations for a well-trained workforce.
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Implementation of Rapid Microbial Methods for Air and Water Monitoring in Pharmaceutical Industry
Igor Gorsky
2 hrs
Product Id: 704560
This training program will dispel mistaken paradigms regarding the risk based approach to introduction of rapid microbial detection systems for water systems. Attendees will understand how to validate and transfer LIF method and how to validate LIF instrument against currently used methods.
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Biological Facility Design: Design for Compliance
Erich Bozenhardt
60 Min
Product Id: 704576
This training program will explore the ABCs of facilities enhancement – compliance-driven actions that get results. It will also discuss devising and implementing a bullet-proof plan to reach goals, set expectations, and lower costs.
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US, EU, Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus
Robert J Russell
90 Min
Product Id: 704587
This 90-minute webinar will help you gain a comprehensive understanding of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will prepare you for regulatory inspections in these countries.
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Methods for Detecting Mycoplasma Contamination in the Manufacture of Pharmaceuticals and Biologics
Michael Simonian
90 Min
Product Id: 704185
This training program will help attendees understand the sources of mycoplasma contamination and how to minimize the occurrence of contamination. The regulatory standards for testing will be described as well as the methods of mycoplasma detection and the resources for testing. At the conclusion of this webinar, attendees will have knowledge of the importance of mycoplasma contamination testing and how to successfully perform the tests in their company’s setting.
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Integration of ERP and Legacy FDA-Regulated Systems
Carolyn Troiano
60 Min
Product Id: 704547
This training program will assist those responsible for planning, executing or managing the integration of a business system with any laboratory system governed by FDA regulations. On completing the program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, and how they apply to any integrated business system.
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CAPA Investigations - Tools for a Compliant and Effective Investigation Process
Carlos Rodriguez Garcia
60 Min
Product Id: 704039
This training program will provide professionals with essential elements of CAPA investigations to assure compliance with regulatory requirements. The corrective and preventive action (CAPA) program is an essential element of a compliant quality management system, as required by international regulations and voluntary standards. Investigations are the backbone of the CAPA program.
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3D Printing for Manufacturing Regulated Products: FDA's Current Acceptance and Future Projections
Mukesh Kumar
60 Min
Product Id: 703621
The webinar will discuss the current available regulatory pathways to develop FDA-regulated 3D printed products and also predictions on what to expect in the near future. 3D printing in personalized treatments will be discussed and attendees will be provided practical tips for pursuing approval with the FDA.
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3-Hour Virtual Training: Russia Regulatory Compliance Requirements for Life Science Products
Robert J Russell
3 hrs
Product Id: 704356
This training course will provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of life science products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in Russia. It will offer a deeper understanding of cultural norms, and will discuss best practices for establishing relationships and protecting your intellectual property to be integrated into your company’s training and corporate business strategies.