Skillpad Compliance

Quality and Compliance Consulting Services

Life Science Industry consultants with experience-based knowledge and a passion for solving compliance challenges

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Skillpad's Compliance Consultants are industry veterans with decades of experience who can help you tackle the Life Science Industry's most demanding Compliance challenges.  With experience in the current regulatory environment, Skillpad's Compliance Consultants are working on:
  • Quality Programs
  • Audits 
  • SOPs 
  • Inspection Readiness 
  • Clinical Trials 
  • Training 
  • Project Management 
  • GxP Coaching 
  • Vendor Oversight 
  • Regulatory Affairs
  • Computer System Validation
  • Equipment & Systems Validation
  • Cleaning Validation
  • and more...
Skillpad's Compliance philosophy is to use a lean, risk-based approach so that our clients can achieve their objectives in a timely manner and reduce the likelihood of costly losses.  Our emphasis is on building quality into processes and systems in a pragmatic fashion that allows the client to focus on their core business, and to be confident that they have quality alignment throughout the organization.
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GxP Compliance

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Quality

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Clinical Trials

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Training

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Regulatory Affairs

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Clinical Inspection Readiness Podcast - Episode 1

Clinical Inspection Readiness Podcast - Episode 1

This Podcast is part of a series done by Solabs' Mandy Gervasio, and features an in-depth discussion with Skillpad Compliance Team, VP Compliance, Nathalie Bourgouin.

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Clinical Inspection Readiness Podcast - Episode 2

Clinical Inspection Readiness Podcast - Episode 2

This Podcast is part of a series done by Solabs' Mandy Gervasio, and features an in-depth discussion with Skillpad Compliance Team, VP Compliance, Nathalie Bourgouin.

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Clinical Inspection Readiness Podcast - Episode 3

Clinical Inspection Readiness Podcast - Episode 3

This Podcast is part 3 of a 4-part series, where Skillpad's VP Compliance, Nathalie Bourgouin, discusses Inspection Readiness with Solabs' Mandy Gervasio. Today's discussion focuses on "Execution and Monitoring"

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Clinical Inspection Readiness Podcast - Episode 4

Clinical Inspection Readiness Podcast - Episode 4

Skillpad's Nathalie Bourgouin, VP Compliance, discusses the 'Close' phase of Clinical Trial Inspection Readiness with Solabs' Mandy Gervasio. This is the 4th and final part of the series, and is full of insights that come from 2 decades of experience.

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Specificities of GCP Quality Systems

Specificities of GCP Quality Systems

This Episode is part of the "Automating Quality" series produced by Solabs featuring an interview between Solabs' Mandy Gervasio and Skillpad's Nathalie Bourgouin. The focus of this episode is to help companies improve their quality levels.

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Inspection Readiness from a GCP and GMP Lens

Inspection Readiness from a GCP and GMP Lens

This episode of Solabs "Automating Quality" series of Podcasts features a discussion between Solabs' Mandy Gervasio and Skillpad's Nathalie Bourgouin on the subject of distinguishing between GCP and GMP aspects of Inspection Readiness.

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White Paper: Temperature Control - New GUI-0069 rules are coming for the Transportation & Storage Industries

Examines the new GUI-0069 Health Canada Temperature Control rules for the transportation and storage industry

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White Paper: The Importance of Data Integrity in Regulated Industries

Data Integrity is one of the most important factors in the Life Sciences Industry. It is vital to Laboratory, Manufacturing, Drug Development, Clinical Trials - and it is also widely mis-understood and poorly applied. This White Paper offers an overview of the subject of Data Integrity, and is a useful starting point for your company's operational discussions.

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Strategy Briefing: Remote/Virtual Audits GxP Audits for Vendors and Clinical Sites

GXP Audits for Vendors and Clinical Sites are an essential part of managing Clinical Trials.

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