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Understanding the Full Realm of Product Liability
Randall Goodden
60 Min
Product Id: 704743
This training program will highlight all the key areas that need to be under control or can lead to product recalls, product liability lawsuits, and the causes of these economic disasters for manufacturing corporations.
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Lyophilization: What you Need to Know, Validation and Regulatory Approaches
John R Godshalk
60 Min
Product Id: 704845
In this webinar, attendees will learn how lyophilization cycles are developed, how lyophilizers work and how they are controlled and what is important to FDA and other regulatory bodies in the inspection of lyophilizers and in the validation process.
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ISO 9001:2015 Transition Overview
Kevin Gholston
90 Min
Product Id: 704781
The new ISO 9001:2015 requires companies to establish context of the organization and utilize this perspective along with the new High Level Structure (HLS) Clauses. This webinar is designed for quality assurance managers, management representatives, ISO 9001 implementation teams, and quality management system auditors. With the release of ISO 9001:2015 in September 23, 2015, now is the time to prepare. This 9001-2015 Transition Overview course will highlight the changes from the ISO 9001:2008 revision.
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4-Hr Virtual Training: Key Factors to Write an Effective Standard Operating Procedure and Work Instructions
Joy McElroy
4 hrs
Product Id: 704778
This training program will guide attendees in writing effective Standard Operating Procedures and Work Instructions. It will also discuss how to assess and write to the audience and how to review and revise SOPs and Work Instructions.
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Risk-Based Monitoring Beyond the RACT
Beat Widler
60 Min
Product Id: 704721
This training program will explain what the strengths and weaknesses of the RACT are and where it should be used with caution. It will also elaborate on what needs to be done to establish a comprehensive risk management approach to support risk-based quality management in clinical trials.
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Social Networks and Pharmacovigilance: What Will Change?
Marco Anelli
90 Min
Product Id: 704690
This training program will examine the different types of social networks (Facebook, Twitter, etc.) and help identify similarities, differences, and challenges for pharmacovigilance (PV) professionals. It will also analyze social networks and the new approach to benefit/risk ratio.
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Sterilizing Grade and Prefilter
Mark Trotter
90 Min
Product Id: 704703
This training program will review the latest industry filtration technologies and standards with an overview of regulatory requirements. It will also discuss why and how to determine which filter, the media, and pore ratings that are appropriate for various filtration applications. The program is designed for experienced as well as those new to biopharmaceutical processes. The need-to-know current requirements for specifying sterilizing grade and prefilters in biopharm processes will also be discussed.
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Effective CDISC Clinical Data Acceptance Testing and Compliance
Sunil Gupta
75 Min
Product Id: 704687
This CDISC training program will enumerate clinical data issues, effective methods and SAS macros to identify data issues, and communicating and monitoring improvements in clinical data issues.
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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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Medication Errors: Will the New Requirements Impact Your Processes?
Marco Anelli
90 Min
Product Id: 704717
Medication errors can occur for many reasons at the time of prescribing, dispensing, storing, preparation or administration of a medicine. It is estimated that among hospitalized patients 18.7% to 56% of adverse events are caused by medication errors. This training program will analyze the European Medicines Agency’s (EMA) recently published good practice guide on medication errors to improve the reporting, evaluation and prevention of medication errors by regulatory authorities and pharmaceutical industry throughout the EU.
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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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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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Technology Transfer and Validation for Medical Devices and Pharmaceuticals: The Link between Development, Validation and Commercial Production
Carlos Rodriguez Garcia
60 Min
Product Id: 704248
The parallel requirements for medical devices and pharmaceuticals are incorporated into this comprehensive webinar that delineates the foundation for technology transfer and validation, encompassing regulatory requirements and voluntary guidance.
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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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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.