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C-TPAT Compliance for FDA-Regulated Industries
Carolyn Troiano
90 Min
Product Id: 706158
Attend this webinar to get an overview of the Customs and Trade Partnership Against Terrorism including “Tiered” strategy, guidelines, highlights, and compliance. We will also cover the major areas needed to build a successful framework that will support your compliance program including policies, SOPs, documentation, and training.
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CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule)
Sunil Gupta
90 Min
Product Id: 704313
This training program is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Through case study analysis, the course will examine best practices to provide thoughts and ideas to develop or improve the CDISC mapping system.
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Process Reliability Modeling: Measure the Cause Not the Effect of Process Variations
Michael Abitz
60 Min
Product Id: 705334
This webinar will discuss in detail Process Reliability Modeling (PRM) method including its history, the process, validation, and results of effective management, sigma score and customer satisfaction. Attendees will learn how to convert qualitative information into quantitative data to determine process and system reliability.
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Understanding Aseptic Technique and Cleanroom Behavior
Danielle DeLucy
60 Min
Product Id: 704429
This training program will discuss how, in sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination. It provides sterility, safety, and efficacy to the sterile product, especially various injections for patients. In this course, cleaning, gowning and proper methods of contamination control will be reviewed along with why clean rooms are designed the way they are.
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Combination Drug/Device Products CGMPs - Final Rule
John E Lincoln
90 Min
Product Id: 702810
This training on combination product regulations will evaluate the chief areas of concern or change in the new CGMP requirements for combination products, 21 CFR Part 4, and clarify many of the issues and questions that arise involving combination products.
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The PSMF- Accountability, Inspection Preparation and Business Analytics
Christine Wittrock
60 Min
Product Id: 706080
This webinar will discuss the structure of the PSMF as per EU Directive 2010/84/EU and how adopting this document in the US will provide a transparent process for Accountability, Inspection Preparation and Business Analytics.
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CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps
Sunil Gupta
90 Min
Product Id: 704302
This training program will assist anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this training. Effective and practical solutions to address real-world issues will be detailed.
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U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements and Cosmetics
Norma Skolnik
60 Min
Product Id: 704371
In order to market dietary supplements and OTC drugs in the U.S., reporting serious adverse events is required. It’s essential to understand these important FDA requirements to assure regulatory compliance and avoid an FDA warning letter or 483 audit issues.
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Toxic Impurities in Active Pharmaceutical Ingredients
Loren Gelber
75 Min
Product Id: 706056
The recent recalls of sartan antihypertensives due to the presence of nitrosamines may suggest increased attention from FDA to toxic impurities in drug products from active pharmaceutical ingredients. The public information about the limits of toxic impurities and about nitrosamines in sartans will be discussed and possible similar situations reviewed in this webinar.
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21 CFR 11 Compliance for Excel Spreadsheet
Angela Bazigos
90 Min
Product Id: 702450
This Excel spreadsheet compliance training will outline the FDA requirements for Excel spreadsheets used in regulated environments and provide guidance on 21 CFR Part 11 validation.
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Label Claims for food, Probiotics and Cosmetic products in Brazilian Regulatory System
Eliana Silva de Moraes
90 Min
Product Id: 706032
In this webinar attendees will learn the brazilian labeling requirement for food, cosmetic and probiotics products, Also attendees will gain a complete understanding of claims regulation for food, cosmetic and probiotics according with the local legislation.
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Pre-Formulation and Formulation Development of Small and Large Molecules for a Lyophilized Product
J. Jeff Schwegman
90 Min
Product Id: 702305
This webinar on lyophilization technology will provide you the understanding physical properties of formulated products through the use of very specialized analytical techniques. Also attendees will learn pre-formulation assessment, pre-formulation studies including choosing an optimal solution pH and buffer system, solubility enhancement, controlling oxidation, and bulking agents.
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The Brazilian Reimbursement System
Eliana Silva de Moraes
90 Min
Product Id: 706031
In this webinar attendees will learn the legal and regulatory framework for reimbursement system in Brazil to have better and effective result when marketing with medical and drug product in Brazil.
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Project Management for Auditors - Improving audit productivity for GCP, GMP and GLP
Laura Brown
60 Min
Product Id: 701982
This Project Management training for Auditors will help you understand how to apply project management principles to auditing to ensure efficient and effective quality assurance of drug development.
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New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products
Angela Bazigos
90 Min
Product Id: 704529
This training program will examine the approval process for drugs, biologics and devices and elaborate FDA submission requirements and guidances. It will also discuss electronic regulatory submission and gateway for FDA and FDA eCTD guidance and specifications.
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Software Validation and its 11 Key Documents
John E Lincoln
90 Min
Product Id: 703097
This webinar focuses on the verification and validation planning and execution of software, after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) and the growing field of "cloud"-based software. A suggested FDA model (mandated for submissions) will be evaluated, implemented, with V&V documentation and test case examples. Also attendees will learn the most recent issues the FDA has had in this area, and remediation approaches.
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FDA Establishment Inspections - What to Expect?
Charles H Paul
60 Min
Product Id: 706007
In this FDA Inspection webinar attendees will learn about the FDA inspection process & the effective techniques how you and others behave and interact with FDA inspectors during an FDA Establishment Inspections.
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Writing Effective and compliant SOPs
Angela Bazigos
90 Min
Product Id: 702429
This FDA compliant SOPs training will explain how to write, organize, and maintain Standard Operating Procedures (SOPs) and train personnel so that you can ensure FDA compliance in a way that is concise, reproducible and easy to follow.
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CDISC Mapping 2: ODM, MindMaps and References
Sunil Gupta
90 Min
Product Id: 704208
This training program will highlight key differences between SDTM and ADaM models and process flows. It will also focus on key differences between the seven CDISC classes and on best practices to create Dataset.XML from SAS. Attendees will gain a better understanding of the structure and syntax of ODM-XML files as well.
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In-Depth Testing of Computer Systems Regulated by FDA
Carolyn Troiano
90 Min
Product Id: 705976
This webinar will focus on testing as a key element of Computer System Validation (CSV). Attendees will learn the way to develop a detailed rationale for testing and how to ensure that it is fully executed and documented in accordance with FDA requirements. You will also be provided with guidance for maintaining the system in a validated state and assessing the level of any testing that might be required post-validation to ensure that compliance.