CDISC for US FDA Submissions - Are you Compliant?
Kit Howard
90 Min
Product Id: 702428
This 90-minute webinar will discuss timelines for CDISC requirements among different market segments (drugs, devices, etc.) and provide clarity on what "compliance" with CDISC standards means. It will also cover resources that you can use for developing and interpreting these standards.
Software Verification and Validation Planning to Meet CGMP Requirements
John E Lincoln
90 Min
Product Id: 701694
This Software Verification and Validation training will help you understand and recognize the most common software V&V failings and their fixes. You will learn how to develop and use a repeatable software V&V template for all software validation projects.
When Employer Rights Clash with Employee Privacy Rights
Susan Fahey Desmond
60 Min
Product Id: 702472
This webinar will help you identify scenarios and situations where the law protects an individual’s (employee’s) privacy and how an employer can conduct a lawful investigation without crossing the line of violating their employee’s privacy rights.
3-hr Virtual Seminar: Human Resources Metrics
Marna Hayden
3 hrs
Product Id: 702471
This 3-hr virtual seminar on logical and meaningful HR metrics will help you in determining what measurements should be used by your company on an ongoing basis and to measure special company goals or initiatives.
Mobile Medical Applications for Devices: Trends, Bills and Guidance
Kosta Makrodimitris
90 Min
Product Id: 702459
This 90-minute webinar will help you understand the current landscape of the growing field of mobile medical applications and the current regulatory efforts to ensure that the related medical devices will not pose high risks for patient safety and promote innovations.
Applying Quality Systems Concepts to Clinical Research Activities
Glenda Guest
60 Min
Product Id: 702492
This webinar will help you identify key concepts from the US FDA Quality System Regulation (QSR - 21 CFR Part 820) that are applicable in the clinical arena, and show how you can build them into your clinical research activities.
Freeze Drying in the Pharmaceutical, Biological and Food industry
J. Jeff Schwegman
90 Min
Product Id: 702486
This 90-minute session will cover the basics of freeze drying as it relates to the pharmaceutical, biological and food industries. Specifically, this session will highlight using a scientific approach to developing an optimal formulation and lyophilization cycle for those freeze-drying in these industries.
Logical Water System Validation
T.C Soli
90 Min
Product Id: 701358
This Water system validation training will guide you on how validation should be customized to your particular water system design and maintenance practices, what operational elements should be included in the microbial testing during validation and which ones need not be. Understanding the purpose of water system validation will allow you to see the fallacies of many standard protocol templates bred by tradition and do only what is appropriate for YOUR water system.
ISO 14001: Complete Overview, Implementation and Compliance
Jasmin NUHIC
120 Min
Product Id: 702437
This 120-minute webinar will provide an overview of the ISO 14001 regulation, its benefits to organizations, the elements of auditing for ISO 14001 and training requirements. You will learn how to implement these standards at your organization ensure compliance.
4-hr Virtual Seminar - Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina)
Robert J Russell
4 hr
Product Id: 702340
This 4-hr Latin America Regulatory compliance requirements training/webinar will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.
Supervisors and Their Role in OSHA Compliance and Safety
Don Dressler
60 Min
Product Id: 702460
This webinar will clarify the role of supervisors under OSHA and provide them with tools to be effective in their jobs and promote safety. You will gain practical and valuable knowledge from the presenter’s extensive experience as an attorney focusing on OSHA compliance.
Making the Business Case for an Integrated GRC Program
Jason Mefford
60 Min
Product Id: 702482
This webinar will equip attendees with the knowledge necessary to efficiently design and enhance GRC activities across the organization based on established GRC standards.
Surviving an OSHA Inspection - Dos and Don'ts
Michael Lawrence
60 Min
Product Id: 702433
This webinar will provide you practical tips on handling the OSHA inspection process with an inspector. You will learn about the types of inspection, the tools you can use, what information to discuss with an OSHA inspector, what records to show and about your rights and responsibilities.
Introduction to Travel Claim Fraud
Paul Gostelow
90 Min
Product Id: 702478
This 90-minute webinar will highlight actual examples of travel fraud that happen in organizations and focus on internal controls that you can have in place to prevent fraud related to travel and subsistence claims.
The New HIPAA Audit Protocol - Know What To Do Before They Call
Jim Sheldon-Dean
90 Min
Product Id: 702456
This 90-minute webinar will explain how HIPAA audits are conducted, what the auditors will look for, what they will ask and how. This training will prepare all HIPAA covered entities and business associates to be fully in compliance and be prepared for an audit at any time and to quickly respond to audits.
Design Controls: What to know when it comes to FDA regulated industry?
Jasmin NUHIC
120 Min
Product Id: 702402
This 120-minute webinar will help medical device manufacturers to understand what you need to do to ensure that your process, the methods, and the procedures that you have established to implement the requirements for design controls are in perfect order.
How to Decommission a Medical OEM Molding Operation and Transfer it to a ''World Class'' Medical Contract Manufacturer
Rob Braido
60 Min
Product Id: 702447
This webinar will provide processes and procedures to all medical device companies that are thinking of transferring equipment, molds, dies, systems and processes to contract manufacturers. It will follow a recent successful case study in the medical industry.
US FDA's Pre-Approval Inspection Program
Sandra N. Whetstone
60 Min
Product Id: 702453
This webinar, by a former USFDA executive, will provide an insider’s insight into the US FDA's pre-approval inspection program, its objectives and the roles and responsibilities of the entities involved in the program.
Employee Fraud Detection and Prevention
Peter Goldmann
90 Min
Product Id: 702440
This 90-minute webinar will summarize current and emerging cyber-threats and provide latest insights and advice from experts on how to protect your organization from individuals - both inside and outside of your organization.
To Validate or Not To Validate: A Daily Question for the Pharmaceutical Scientist
Kim Huynh-Ba
90 Min
Product Id: 702386
This 90-minute webinar will outline the common deficiencies in relation to method validation, for pharmaceutical products, outline regulatory requirements and the change control process needed to stay in compliance.