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Pharmaceutical - Documentation & Proceedings

> Conference documentation, webinars & Proceedings

Recommended
Understanding Disinfection and Cleanroom Cleaning in a FDA Regulated Environment

This 90-minute webinar on Disinfection and Cleanroom Cleaning will cover effective ways to rotate disinfectants, most current industry methods for applying disinfectants and effective methods for controlling residues.

By : Compliance Online
Product Type : On Demand Webinar
Project Management for Auditors – Improving audit productivity for GCP, GMP and GLP

This Project Management training for Auditors will help you understand how to apply project management principles to auditing to ensure efficient and effective quality assurance of drug development.

By : Compliance Online
Product Type : On Demand Webinar
Appropriate and Lawful Off-Label Dissemination- Webinar

Since the prosecution of off-label uses has intensified, companies need to revisit everything they do in the off-label arena. While off-label “sales” have never been illegal, because physicians can and do lawfully prescribe products for off-label uses, off-label “promotion” is illegal.

By : Compliance Online
Product Type : On Demand Webinar
Clinical Statistics for Non-Statisticians. An Introduction to Statistical Concepts and Practices-Webinar

In this Clinical Statistics webinar/training all topics will be taught from a practical, non-theoretical perspective for non-statisticians & value and meaning of descriptive statistics including the use of normal vs. non-normal statistics.

By : Compliance Online
Product Type : On Demand Webinar
Computer System Validation: Step-by-Step Webinar

Learn computer system validation essentials and eight fundamental steps of implementation for cost saving. Understand the structure of validation plan, documentation of ongoing performance, structure of validation report.

By : Compliance Online
Product Type : On Demand Webinar
Conducting a risk assessment for objectionable microorganisms

This webinar on Objectionable Micro-organisms will provide examples of objectionable microorganisms and will review specific actions to take when one is found. It will also review how to conduct an effective risk analysis to mitigate the risk they present.

By : Compliance Online
Product Type : On Demand Webinar
Conducting Successful Product Complaint Investigations Webinar

The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations.

By : Compliance Online
Product Type : On Demand Webinar
Creating a Good Design History File for Audit Success

This webinar will cover the basics on how to maintain a good Design History File that will help a manufacturer during a regulatory compliance audit

By : Compliance Online
Product Type : On Demand Webinar
Defining and Managing Protocol Deviation/Violation/Exception

In this GCP Webinar training, learn how to proactively predict and manage Protocol Deviation/Violation/Exception. Understand the guidance for implementation of “Protocol Not Followed” (PNF).

By : Compliance Online
Product Type : On Demand Webinar
Fundamentals of FDA’s Clinical Trial Audits – A Must- Know for Audit preparation

This Clinical Trial Audits webinar will provide help both CRAs and sites utilize quality improvement methods and effectively prepare for upcoming GCP audits.

By : Compliance Online
Product Type : On Demand Webinar
Lawful Pre-FDA Approval & Pre-FDA Clearance Communication Webinar

How to communicate prior to product launch and off-label discussion to avoid violations of the Anti-Kickback Statute and False Claims Act.

By : Compliance Online
Product Type : On Demand Webinar
The 6 Most Common Problems in FDA Software Validation & Verification

This FDA Software Validation and Verification training/webinar will review the validation planning process with particular emphasis on avoiding six common pitfalls.

By : Compliance Online
Product Type : On Demand Webinar
Auditing Systems for 21 CFR Part 11 Compliance - Webinar By ComplianceOnline

This webinar will present a methodology for system assessment, risk-analysis, 21CFR Part 11 compliance, remediation and inventory, along with templates and forms that attendees can modify for their own business.

By : Compliance Online
Product Type : On Demand Webinar
How do I Keep FDA Happy with my Contract Manufacturer

This webinar will cover techniques and process that can help you assure reliability and consistent quality from your suppliers or contract manufacturers. You will learn how to monitor your supplier and ensure they meet FDA's quality requirements.

By : Compliance Online
Product Type : On Demand Webinar
Raw Materials Risk Management in GMP Facilities: Avoiding GMP non-Compliance Due to Raw Material Issues

This webinar covers FDA’s expectations from GMP facilities regarding raw material vendor selection,expectations from quality control and documentation processes, and training requirements, with case studies.

By : Compliance Online
Product Type : On Demand Webinar