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Technical Writing for Medical Products: SOPs, Investigations and Change Records
Regina Fullin
60 Min
Product Id: 704304
In this training program, attendees will learn quick formatting tips that will make writing more readable and learn how to use formatting tools in a way to maximize the impact of their writing in an electronic system.
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FDA Regulations for Marketing OTC Drugs and New Legislation
Norma Skolnik
60 Min
Product Id: 704145
This training program will illustrate why it’s essential to understand FDA regulations and OTC labeling requirements to market OTC drugs in the U.S.
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Adopting Price Controls for U.S. Prescription Drugs: Federal Policy Outlook for 2019 and Beyond
Dennis Weissman
90 Min
Product Id: 705963
In this prescription drug pricing webinar attendees will the key components of the trump administration on drug pricing plan, elements of the white house drug pricing blueprint and the federal policy outlook for U.S. drug pricing in 2019 and beyond.
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The Most Serious FDA 483s - How to Avoid Them
John E Lincoln
90 Min
Product Id: 702766
This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.
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Reducing Variability in Cell-Based Methods Using Process Controls
Gwen Wise Blackman
60 Min
Product Id: 705933
This webinar will provide a general overview of the cell-based methods using process controls as well as specific examples of successful monitoring of cell-based methods leading to reduced assay failures.
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Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory
Gregory Martin
90 Min
Product Id: 702534
This 2-hr laboratory inspection webinar will discuss strategies to implement before your laboratory is about to undergo a pre-approval inspection or a general GMP inspection. It will help you gain an understanding of the key areas that are likely to be the subject of a laboratory inspection.
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FDA Regulations for Environmental Monitoring (EM) Program
Joy McElroy
90 Min
Product Id: 704377
This training program on applicable regulations pertaining to clean room environmental monitoring (EM) programs will discuss the basics of setting a robust and effective EM program. The course will also detail the relationship between an EM Excursion Program and CAPA and the four phases of clean room transitional monitoring.
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Current Concepts and Challenges in Cloud Compliance
Angela Bazigos
90 Min
Product Id: 703739
Cloud computing has become perhaps the most critical compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantee that management will expect compliance strategies to be developed that will support decisions to utilize cloud environments to perform regulated activities. This presentation will provide a baseline of information related to cloud computing which will help attendees better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.
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CDISC Mapping 1: Specifications and FDA Requirements
Sunil Gupta
90 Min
Product Id: 704152
This training program will discuss CDISC requirements to create SDTMs and ADaMs. It will also offer essential mapping and strategy concepts for creating and validating SDTM and ADaM variables in key CDISC datasets (DM, AE, ADSL, and ADAE).
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Pharmacokinetics/Biopharmaceutics for Chemists/Analysts
Saeed Qureshi
120 Min
Product Id: 705271
This training program will focus on defining and explaining numerous concepts and terminologies in a simple language as related to the safety, efficacy and quality assessment of pharmaceutical products for human use. It will also describe the necessity of understanding the basic physiological concepts pertinent to drug actions, product developments and evaluations.
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Successful Water System Sanitization
T.C Soli
60 Min
Product Id: 705825
This webinar will discuss common problems of sanitization process, the causes of sanitization failures and teach how to troubleshoot and take remedial actions with respect to material, construction methods, biofilm removal process and timing of sanitization.
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Achieving Success and Compliance in the Supply Chain
Danielle DeLucy
60 Min
Product Id: 705907
This webinar will help attendees to understand the quality issues and methodologies that are relevant in current supply chain management to improve your customer satisfaction.
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ASTM 2500: Lessons Learned Through a Decade of Implementation
Kelly Thomas
90 Min
Product Id: 705911
This validation training program will discuss regulatory requirements from the FDA, EU and ICH perspective, review all the detailed guidance on the concepts found in ASTM E2500 to help industry professionals understand how to implement a validation program based on the ASTM 2500 Approach.
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CMC Considerations for INDs and NDAs for 505(b)(2) Products
Peggy Berry
90 Min
Product Id: 705928
In this webinar attendees will learn which products qualify for submissions under 505(b)(2), data that may be referenced, content requirements, and regulatory benefits.
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Data Governance for Computer Systems Regulated by FDA
Carolyn Troiano
60 Min
Product Id: 704745
In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.
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Cell Based Assays: Development and Validation
Michael Simonian
60 Min
Product Id: 704528
This training program will focus on how cell cultures are used for in vitro assays. It will include examples of cell based assay systems and list the advantages of cell based assays. The webinar will help attendees understand the uses of in vitro testing with eukaryotic cell based systems, the parameters to be considered in the development and optimization of a cell based assay and the validation of a cell based assay.
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Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration
Jose Mora
90 Min
Product Id: 703396
This webinar will explain how to apply the theory of lean documents and its corollary theory of lean configuration to present a fresh approach to controlled document system for a life sciences manufacturing plant.
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Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training
Gwen Wise Blackman
180 Min
Product Id: 705019
This 3 hour virtual training will provide an overview of the concepts and types of immune responses elicited by biologics. The factors contributing to immunogenicity and impact on efficacy and safety will be identified. Validated screening and confirmatory methods that measure an immune response to a biologic during the various stages of development, clinical studies and post-approval surveillance will be discussed.
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Analytical Method Validation Best Practices for Pharma Companies
Loren Gelber
90 Min
Product Id: 705838
This analytical method validation webinar will help you understand the various parameters required for a successful method validation. It will highlight various requirements of USP and FDA for a successful method validation. This will be helpful for All pharmaceutical analytical chemists & supervisors responsible for validating new or modified analytical methods, and the personnel responsible for hosting FDA inspections, responding to 483s and Warning Letters or preparing NDAs or ANDAs.
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GMPs for Medical Marijuana Production Operations
Charles H Paul
60 Min
Product Id: 705872
In this webinar attendees will learn the good manufacturing practices required for any medical marijuana production operations related to international and US individual state cannabis regulations to determine how to best operate their cannabis operations.