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Comparing the Pharmaceutical and Medical Device Product Lifecycles
Howard Cooper
120 Min
Product Id: 704853
This webinar will help you gain a greater understanding of regulatory and compliance requirements and how the early product lifecycle requirements establish the basic groundwork as a foundation from product development to commercialization continuing to out commercialization and product discontinuation.
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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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Compliance with Canadian Quality Management System Regulatory Requirements
Edward Kimmelman
90 Min
Product Id: 704726
The training program will provide insight into complying with the key QMS requirements for organizations selling medical devices in Canada.
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Institutional Review Boards (IRBs): The Changing Landscape and the Effect on the Conduct of Clinical Research
Sarah Fowler Dixon
60 Min
Product Id: 703400
This clinical research training will explain the Institutional Review Board (IRB) models. It will discuss the regulatory framework for IRB review including 21 CFR 50, 56 and 45 CFR 46.
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Data Management in Clinical Research
Kesley Tyson
60 Min
Product Id: 704768
This training program will identify regulations and guidelines pertaining to data management in clinical research. Attendees will learn to translate the regulations and guidelines into practical application for each stage of the clinical trial: start-up, ongoing study management, and study closure. The program will also discuss the do’s/don’t for data management activities through real-life examples.
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FDA's Medical Device Software Regulation
Casper Uldriks
90 Min
Product Id: 704749
This training program will focus on FDA software guidance. It will elaborate on applying current provisions that NIST (National Institute of Science and Technology) has put forth in recent reports that FDA will integrate into its regulatory oversight as well.
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When Studies are Exempted from IND Requirements: Understanding the Criteria and the Consequences
Jennifer Holcomb
60 Min
Product Id: 702345
This Clinical compliance training will review the purpose of INDs and the process for obtaining an IND. Attendees will gain a complete understanding of the criteria for exemption and the impact an exemption has on a study.
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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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FDA Pre-Approval Inspection Readiness: Actionable Steps to Prepare for a BIMO Inspection
Nicole Tesar
60 Min
Product Id: 704640
This 60-minute training program is designed for those working in the field of clinical research either as a sponsor (pharmaceutical/biotech company) or a research site. The session will discuss key FDA inspection terminology, types of BIMO inspections, site inspection procedures, and sponsor inspection procedures. Attendees will understand when an inspection is likely to be scheduled and the current trends in findings.
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How to Write Error Free and FDA Compliant Procedures
Ginette M Collazo
90 Min
Product Id: 704122
This training program will focus on the importance of procedures. Attendees will learn why people avoid procedures and understand common human errors and deviations related to the use of procedures.
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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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Grant Writing - All You Need to Know About Criteria, Parameters, Obligations, Application Structure and Grant Reporting
Vidia Ramdeen
60 Min
Product Id: 704550
This training program will help participants identify grant opportunities and get started with the grant writing process. They will gain insight into public/private grants, the grant application process and grant reporting.
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Equipment Calibration, Maintenance, and Validation: What Auditors Look for in a Controlled Process
Jeff Kasoff
60 Min
Product Id: 701786
This webinar will discuss the different aspects which auditors generally look in equipment calibration, maintenance and validation and highlight the best practices.
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Medical Device Complaints, MDR's and Recalls
John Chapman
60 Min
Product Id: 700196
This training program on medical device complaint handling will discuss in detail the FDA regulations and the regulatory process with respect to medical device complaint handling, reporting and recalls.