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Regulatory Affairs Training - Live Webinars, Recordings & CDs
Hundreds of regulatory affairs specialists each year use ComplianceOnline courses to learn skills and get a clear understanding of specific regulatory requirements needed to succeed in their role. On this page, you will find a broad range of courses specially designed for you. Whether you work in the pharmaceutical, medical device, and equipment, biotechnology, cosmetics, research, or regulatory agencies, or within legal, marketing, and scientific consulting firms, you can get acquainted with the regulatory requirements and guidance for your industry. With the knowledge you gain, you will learn how to apply the regulations in a compliant manner into the actual materials that your company manufactures. You will be in a better position to understand the risks your organization faces. You will get a robust understanding of compliance within the scope of your duties. With the knowledge you gain, you can evaluate current practices and make improvements where necessary. Join them!
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The Regulatory Expectations for Environmental Monitoring Programs
- Speaker: Kenneth Christie
- Product ID: 703648
- Duration:
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Challenges of an Effective Change Control Program
- Speaker: Kenneth Christie
- Product ID: 704638
- Duration:
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Auditing Business Continuity Plans According to ISO 22301
- Speaker: Michael C Redmond
- Product ID: 704410
- Duration:
This training will cover the best practices for implementing and auditing a Business Continuity Plan. The speaker will discuss the lifecycle of a BCP program with specific emphasis on Risk Assessment and Business Impact Analysis, Designing a living BCP & Testing & Maintenance. The program will also detail the various standards from FFIEC to ISO. Participants will understand what’s involved in a full BCP program and have insights based upon field experience that can be applied to Internal Audit work and BCP. The session will provide you with tools that you can bring back to your company to improve upon BCP programs & ability to audit them to provide targeted recommendations.
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Basic Requirements for IQ, OQ and PQ Protocols
- Speaker: Kenneth Christie
- Product ID: 704591
- Duration:
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4-Hr Virtual Training: Ten Steps to Data Integrity in Pharmaceutical and Biotech Labs
- Speaker: Nanda Subbarao
- Product ID: 704730
- Duration:
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Excursion Studies to Support Transporting and Distributing Clinical and Commercial Products
- Speaker: Kim Huynh-Ba
- Product ID: 704421
- Duration:
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Annual Analytical Laboratory Data Integrity Training
- Speaker: Nanda Subbarao
- Product ID: 705326
- Duration:
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Pack of two courses: The essentials of Food and Drug Administration Medical Device Regulations: A primer for manufacturers and suppliers
- Speaker: Edwin L Bills
- Product ID: 700957
- Duration:
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$349
$349
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Avoiding FDA observations: Do's and Don'ts during Laboratory Inspections
- Speaker: Kim Huynh-Ba
- Product ID: 703278
- Duration:
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How to Buy COTS Software, and Audit and Validate Vendors
- Speaker: David Nettleton
- Product ID: 703820
- Duration:
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GMP Requirements for Validation and Re-Validation of Analytical Procedures
- Speaker: Kim Huynh-Ba
- Product ID: 703041
- Duration:
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Quality Metrics and the Issues with the FDA’s Revision Draft Guidance Quality Metrics Data
- Speaker: Barry A Friedman
- Product ID: 705452
- Duration:
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Stability Program for Pharmaceuticals and Biologics
- Speaker: Nanda Subbarao
- Product ID: 705455
- Duration:
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Managing your GMP Quality Control (QC) Labs in Compliance with FDA Regulations
- Speaker: Kim Huynh-Ba
- Product ID: 705081
- Duration:
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The New Part 11 Inspections: Requirements for Validation and SaaS/Cloud Applications
- Speaker: David Nettleton
- Product ID: 704734
- Duration:
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Studies to Support Temperature Excursions and Shipping of Pharmaceutical Products
- Speaker: Kim Huynh-Ba
- Product ID: 704770
- Duration:
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Establish an Effective Change Management Process for Stability Studies
- Speaker: Kim Huynh-Ba
- Product ID: 704085
- Duration:
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Annual GLP Refresher Course - 4 Hour Virtual Training
- Speaker: Nanda Subbarao
- Product ID: 704893
- Duration:
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Webinar - Latin America – Understanding Regulatory Compliance Requirements Across Life Science Industry PART I & PART II
- Speaker: Robert J Russell
- Product ID: 701350
- Duration:
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$299
$299
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Japanese PAL – JPAL Technical, cultural and language challenges when dealing with MAH, PMDA, Distributors and Customers
- Speaker: Phil Smart
- Product ID: 701292
- Duration:
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