
How to Manage an FDA Inspection
Susan C Reilly
60 min
Product Id: 700298
This FDA Inspection training is designed to provide the tools and practices necessary to effectively prepare for and manage a successful FDA inspection.

Internal Auditing of Risk Management: Emphasis on effectiveness and compliance to QSR, ISO 13485 and ISO 14971
Phil Smart
60 Min
Product Id: 700272
This Internal audit training will guide on how to set up an ISO 14971 audit program with specific auditor guidelines.

Best Practices in Monitoring and Measurement Tools & Techniques to ensure that Your Organization's Processes are performing Up to Expectations
Michael A Mathe
60 Min
Product Id: 700268
This Quality compliance training will present and identify ways that your (ISO 9001 8.2.3) process monitoring and measurement tools can Lead your organization to fast and efficient corrections when problems occur.

Establishing Effective Business Strategies for Managing Outsourced Services
Richard Barrett
60 Min
Product Id: 700275
This Pharmaceutical training starts with the drivers for outsourcing and investigates the importance of measures of success and how they apply in implementing strategy.

Technology Transfer of a Pharmaceutical Manufacturing Process
Rodney E Thompson
60 Min
Product Id: 700247
This webinar will cover the essential aspects for the cGMP-compliant technology transfer of a pharmaceutical manufacturing process.

Auditing a Process-based System
Dr. Sandford Liebesman
60 Min
Product Id: 700260
This Internal Audit training will provide valuable assistance to organizations desiring to comply with ISO 9001:2000 and will provide the internal audit functions with methodology and tools to better perform internal audits.

Outsourcing analytical and pharmaceutical development
Michael Gamlen
60 Min
Product Id: 700231
This webinar is targeted at people responsible for outsourcing, and at contractors who wish to ensure they provide excellent services which will generate them repeat business.

Supplier Evaluation and Internal Auditing for FDA and ISO 13485 Compliance: Pack of Three Courses
Betty Lane,Frank Stein,Jeff Kasoff
Product Id: 700288

Medical Device QSR (21 CFR Part 820), Design Control, Hazard Analysis Under ISO 14971 and ICH Q9: Pack of 3 Courses
Paul Larocque,Jose Mora,John E Lincoln
Product Id: 700287

Implications of the US PATRIOT Act for international financial services agencies
Kenneth Barden
60 Min
Product Id: 700248
In this Financial services training will examine the provisions of the PATRIOT Act that affect international financial institutions, along with recent regulations implementing those provisions.

Quality Management for FDA QSR and ISO13485 Compliance: Pack of Two Courses
Susan C Reilly,William G Mclain
Product Id: 700289
Best practices in Quality Management System and management controls needed to meet US FDA and ISO 13485 requirements This pack of two training courses provides 2 hours of training on basic requirements and best practices of quality management system for non-Regulatory and Quality Assurance experts in the medical devices industry as well as principles and practices needed to effectively develop and implement the Management Controls necessary to ensure an effective Quality Management System (QMS) and to comply with the requirements of the FDA QS Regulation

ISO 27001: Relationship to other standards - ISO 17799, ISO 20000, CobiT, and the integrated management system
Alan Calder
60 Min
Product Id: 700244
In this Quality compliance training comprehensive guidance on ISO/IEC 27001:2005 that will aid and assist practitioners and managers the world over.

What Every Firm Should Know About Business Continuity Compliance
Henry Theberge
60 Min
Product Id: 700251
This Corporate governance training will provide a basic understanding of business continuity, discuss why business continuity is important, for compliance with rule 466 and others, clarify what to look for during audits.

Validation of Computerized Analytical Systems
Dr. Ludwig Huber
60 Min
Product Id: 700212
This Validation training will give a good understanding on what the requirements are and how to validate laboratory computer systems in the most cost-effective way.

Reprocessing Reusable Medical Devices - Cleaning & Labeling Requirements - validations
John Chapman
60 Min
Product Id: 700245
This Medical device training will explain the regulatory requirements including cleaning and sterilization methods & validations.

Validation for FDA and ISO 13485 Compliance: Pack of Two Courses
Carolyn Troiano,John E Lincoln
Product Id: 700270
Computer system validation and risk-based verification and validation planning to meet US FDA and ISO 13485 requirements This pack of two training courses provides 2 hours of training on Computer system validation and risk-based verification and validation planning to meet US FDA and ISO 13485 requirements.

Implementing an Environmental Management System to ISO 14001
Jayne Pilot
60 Min
Product Id: 700261
This Environmental Management training will discuss the advantages of a company’s management system to the international standard’s requirement and a simple to follow, Three Step Process for its implementation.

CGMPs for Investigational Drugs and Biologics
Barbara Immel
60 Min
Product Id: 700234
The European Union has stated their requirements in Annex 13, while FDA has recently issued a controversial new phase 1 guidance Join us for a discussion of actual requirements, and both historic and current guidance document recommendations

Preparing for an FDA Inspection
Sue Jacobs
60 Min
Product Id: 700250
This FDA Inspection will discuss FDA inspection readiness techniques and how to prepare your organization for a facility inspection.

Radiation Dose Setting - Method VDmax
Joyce Hansen
60 Min
Product Id: 700227
This presentation is the third of three presentations on the methodologies for the determiniation of the minimum sterilization dose.