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Preparing for FDA Pre-Approval Inspections
Peter Calcott
60 Min
Product Id: 700894
An assessment of your people to determine who should be talking with the FDA and most importantly, who should not must be performed. This webinar will provide the process map for the compliance and quality staff to build their strategy and plans for preparing for and executing their preparation work for a PAI in the Pharmaceutical and Biotechnology world.
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CAPA Management and Compliance with Regulatory Requirements
Bernice Russell Bond
75 Min
Product Id: 700943
This regulatory training will provide benefits to companies’ required to have a process for collecting, assessing and documenting deviation and complaints and ensuring that corrective and preventive actions are compliant with GXP requirements.
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Clinical Research Organization Audit for Good Clinical Practice
Ronald Schoengold
90 Min
Product Id: 700907
This Webinar defines the role of the CRO to ensure that each party is meeting its responsibilities. CRO audits ensure that the study data and results are credible and accurate, and that the rights and well-being of study subjects have been protected.
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Effective CAPA Management: How to Implement a Risk-based Approach to Improve Your Quality System
Ken Peterson
Product Id: 700994
In this course, we will introduce you to a new method of managing your CAPA system, The Gateway: A Risk-based Filter. This webinar is geared toward professionals in the QA/AC and CAPA discipline and is appropriate for individuals who are regularly called upon to resolve problems, or whose input would aid in preventing problems.
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How to Prepare for FDA GMP Inspections
James Harris(PhD)
60 Min
Product Id: 700990
This program outlines a system for preparing for an unexpected inspection and details SOPs that should be established in advance of the appearance of an inspector at your front door. This Webinar will provide valuable assistance to all regulated companies that face unscheduled inspections by regulatory agencies.
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Designing an Effective Cleaning and Disinfection Program for Pharmaceutical, Biotech, and Medical Device Cleanrooms
Jim Polarine
90 Min
Product Id: 700995
This webinar will provide valuable assistance to all FDA and EMEA regulated companies that need to validate their cleaning and disinfection programs.
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Investigator responsibility/Legal commitment in drug and device clinical research: the reality
Charles H Pierce
90 Min
Product Id: 700923
To follow the regulations is Good Clinical Practices (GCP) and common sense. To not know and follow these regulations is folly. This Webinar will provide invaluable assistance to investigators and staff with regulatory/ legal responsibilities. It also delves into the complex ethical considerations in pharmaceutical product (drug or device) research involving human subjects.
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IDE (Investigational Device Exemption) for PMA and 510(k) for CDRH and CBER
E.J Smith
60 Min
Product Id: 700956
This presentation covers all of the steps one should take when beginning the IDE process for a PMA.
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Introduction to Process Capability (Cp, CpK, Pp, Ppk)
Lawrence Mucha
60 Min
Product Id: 700342
This webinar will provide valuable assistance to all regulated companies that need to validate their systems In this session we will introduce basic control charting and statistical methods to determine if a process is capable of consistently producing product within specifications and how to make it capable if it is not
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Learning from Laboratory-related FDA Warning Letters
Steven S Kuwahara
90 Min
Product Id: 700951
This presentation will cover laboratory-related warning letters that contain 483s related to regulatory issues that affect pharmaceutical companies. While recent warning letters will receive the heaviest scrutiny, we will also cover old warning letters that serve to illustrate important points.
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Organization of Clinical Datasets in eCTD Submissions
Antoinette Azevedo
90 Min
Product Id: 700992
This presentation will review the documentation requirements, the electronic navigation aids required for all the components of the electronic datasets package for a clinical study. This webinar will provide valuable assistance to all pharmaceutical and biotechnology that are conducting clinical studies with the intent of filing Investigational New Drug (IND) and New Drug Applications (NDA) or Biological License Applications (BLA) submissions.
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Designing an Effective and Efficient Internal Audit Process for Your Quality Management System
Michael A Mathe
60 Min
Product Id: 700170
This webinar will focus on designing a thorough internal audit set of process tools, accurately captured in your internal audit procedure that will provide many years of payback and dividends for your organization.
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Validating spreadsheets: strategies for satisfying FDA requirements
Alfonso Fuller
90 Min
Product Id: 700969
This presentation explores strategies for recognizing when validation is required, how to achieve compliance and what documentation needs to be generated and maintained.
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Premarket Approval (PMA) agreement with FDA for the medical device companies - the Requirements
E.J Smith
60 Min
Product Id: 700955
This class reviews the modular option of filing a PMA and the benefits it offers all companies having to negotiate through the PMA process.
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How to Prepare and Submit a Bullet Proof 510(k) Submission
David Dills
60 Min
Product Id: 700981
This webinar will provide valuable assistance and guidance to all medical device companies that are preparing and submitting 510(k)s to FDA for review and approval.
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Security Standards ISO 27001 and 27002: What they are and how to use them
Diana Kelley,Ed Moyle
Product Id: 700868
In this webinar, ISO certified lead auditor for 27001, Ed Moyle, and Diana Kelley, Partner at Security Curve, will explain how organizations can use the ISO standards as a baseline for their security and risk management program. This webinar will provide valuable assistance to all companies are building and maintaining information security management systems.
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Small GMP problems which cause the biggest enforcement headaches: how to tackle them
Steven S Kuwahara
75 Min
Product Id: 700950
The presentation will use examples taken from warning letters to illustrate some of these problems, and discuss possible solutions. As an example, we will discuss the process for accepting raw material.
The Employment Law System and how to stay above the legal line
Scott Baird
60 Min
Product Id: 700810
In this webinar we will cover the legal principles developed by the common law concerning employee privacy, the major anti-discrimination laws.
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Data and Safety Monitoring in Clinical Research Involving Human Subjects - When and How
Charles H Pierce
90 Min
Product Id: 700924
This webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. All Clinical Research protocols have a prominent safety monitoring plan as part of the overall research plan / protocol. This "plan" is to ensure the safety of participating subjects and to ensure the validity and integrity of the data.
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The Essentials of Food and Drug Administration Medical Device Regulations:A Primer for Manufacturers and Suppliers - Registration, Medical Device Reporting, Corrections and Removals (Recalls)
Edwin L Bills
90 Min
Product Id: 700922
This program will cover the remaining regulations excluding the QSR which was covered in Part 1. This webinar is especially helpful for new startup companies that are entering the medical device field for the first time.