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Home › Online Training ›  FDA Training

FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

Sub Categories: Risk Management | Packaging and Labeling | FDA Audit and Inspection | Drug and Device Approvals | FDA Validation | FDA 21 CFR Part 11 | Marketing and Promotion | Documentation and IT | Quality and Safety | Regulations & Guidances | Best Practices & GXPs
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Day 2 - Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

Day 2 - Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

  • Speaker: Barry A Friedman
  • Product ID: 706615
  • Duration:
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Day 1 - Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

Day 1 - Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

  • Speaker: Barry A Friedman
  • Product ID: 706614
  • Duration:
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Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
3
/ Mar
Wednesday-2021

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

  • Speaker: David Nettleton
  • Product ID: 701582
  • Duration: 75 Min
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.
* Per Attendee
$229
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Is my Data Abnormal? Normality Tests and Transformations
4
/ Mar
Thursday-2021

Is my Data Abnormal? Normality Tests and Transformations

  • Speaker: Elaine Eisenbeisz
  • Product ID: 706630
  • Duration: 90 Min
Many of the commonly used statistical tests and calculations of chart limits (or other measurements) require that the data be “normally distributed”. This webinar will show you how to check for normality in your data and apply transformations to non-normal data. You will also learn tools and concepts to understand when a transformation of data is, or is not, necessary.
* Per Attendee
$229
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How to Prepare a Standard Operating Procedure (SOP)?
10
/ Mar
Wednesday-2021

How to Prepare a Standard Operating Procedure (SOP)?

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705131
  • Duration: 60 Min
This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.
* Per Attendee
$229
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Implementing a Robust Data Integrity Program
12
/ Mar
Friday-2021

Implementing a Robust Data Integrity Program

  • Speaker: Kelly Thomas
  • Product ID: 706178
  • Duration: 90 Min
This webinar will detail a data integrity governance program and principles for defining quality and data integrity into processes and systems. It will cover the common problems from FDA 483 observations and warning letters and teach you how to avoid them.
* Per Attendee
$249
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The 6 Most Common Problems in FDA Software Validation and Verification
17
/ Mar
Wednesday-2021

The 6 Most Common Problems in FDA Software Validation and Verification

  • Speaker: David Nettleton
  • Product ID: 705582
  • Duration: 120 Min
This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
* Per Attendee
$249
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Human Error and Cognitive Load: How to Reduce Memory and Attention Failures
18
/ Mar
Thursday-2021

Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

  • Speaker: Ginette M Collazo
  • Product ID: 704210
  • Duration: 60 Min
This training program will discuss the types of human error, the taxonomy of human error, human error reduction initiatives, individual performance, cognitive load and human error, cognitive load categories, and more.
* Per Attendee
$229
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Statistical Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies
25
/ Mar
Thursday-2021

Statistical Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies

  • Speaker: Elaine Eisenbeisz
  • Product ID: 706650
  • Duration: 90 Min
This webinar provides the logic and processes for determining samples sizes for common tests used in verification or validation of processes. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures and formulas to use for the determining sample size and providing justification for the planned sample sizes.
* Per Attendee
$249
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Writing and Revising SOPs for Increased Operational Efficiency
31
/ Mar
Wednesday-2021

Writing and Revising SOPs for Increased Operational Efficiency

  • Speaker: Rob MacCuspie
  • Product ID: 706214
  • Duration: 60 Min
This webinar will discuss how to more effectively write and revise standard operating procedures (SOPs) with a focus on increasing operational efficiencies.
* Per Attendee
$229
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Best Practices in Preparation for an FDA Computer System Audit
1
/ Apr
Thursday-2021

Best Practices in Preparation for an FDA Computer System Audit

  • Speaker: Carolyn Troiano
  • Product ID: 706354
  • Duration: 90 Min
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit. It will also consider areas where FDA will likely focus their effort, including on the higher-risk systems. It will cover areas that will help you to plan for an on-site inspection.
* Per Attendee
$249
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Annual Current Good Manufacturing Practices (cGMP) Training
9
/ Apr
Friday-2021

Annual Current Good Manufacturing Practices (cGMP) Training

  • Speaker: Kelly Thomas
  • Product ID: 705422
  • Duration: 60 Min
This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.
* Per Attendee
$199
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Is My Nanotechnology Safe? Approaches For NanoEHS Risk Assessments
28
/ Apr
Wednesday-2021

Is My Nanotechnology Safe? Approaches For NanoEHS Risk Assessments

  • Speaker: Rob MacCuspie
  • Product ID: 706181
  • Duration: 60 Min
This webinar will discuss how to use tiered approaches to evaluate the benefits and risks of novel nanomaterials and product formulations containing nanomaterials, as well as common risk mitigation approaches.
* Per Attendee
$229
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Data Integrity Compliance for Computer Systems Regulated by FDA
11
/ May
Tuesday-2021

Data Integrity Compliance for Computer Systems Regulated by FDA

  • Speaker: Carolyn Troiano
  • Product ID: 706352
  • Duration: 90 Min
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. In this webinar, you will learn about these FDA trends in compliance and enforcement, as they relate to data integrity, and how to improve your practices to meet compliance requirements.
* Per Attendee
$229
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Recorded/CD
Deviation Management - Investigations to Root Cause Analysis

Deviation Management - Investigations to Root Cause Analysis

  • Speaker: David Husman
  • Product ID: 706636
  • Duration: 60 Min
This webinar will discuss the steps to perform a good fact-based investigation, tools, and when to use them for analyzing facts gathered during investigation to identify one or more root causes and Tools for determining appropriate actions to take to address identified root cause(s).
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Recorded/CD
Statistical Elements of Small Sample Sizes and Only 3 Lots in Process or Product Validation

Statistical Elements of Small Sample Sizes and Only 3 Lots in Process or Product Validation

  • Speaker: Elaine Eisenbeisz
  • Product ID: 706635
  • Duration: 90 Min

Attendees of this webinar will learn statistically valid methods for using small sample sizes and for using lots as few as 3 when validating processes or products.
The focus of this webinar is on providing the information needed for attendees to understand the concepts of risk in relation to process validation and to be able to compute sample sizes and lot sizes according the desired or required specification criteria or the process or product.

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Recorded/CD
GMP for Active Pharmaceutical Ingredients

GMP for Active Pharmaceutical Ingredients

  • Speaker: Paul Larocque
  • Product ID: 706621
  • Duration: 90 Min
This webinar reviews the requirements for good manufacturing practices for active pharmaceutical ingredients. It is based on the requirements of International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and its document Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
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Recorded/CD
Deviation Management - Workshop - Training for the Principal Investigator

Deviation Management - Workshop - Training for the Principal Investigator

  • Speaker: David Husman
  • Product ID: 706623
  • Duration: 4 Hrs
This workshop is designed to train the principal investigators charged with executing deviation investigations. It will present tools and how they are used to gather facts about a problem, evaluate those facts to determine root cause, develop corrective actions and to tell a coherent story of the execution of the deviation management activity.
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Recorded/CD
USDA New Proposed Rule on BioEngineered (GMO) Food Disclosure

USDA New Proposed Rule on BioEngineered (GMO) Food Disclosure

  • Speaker: Kelly Thomas
  • Product ID: 706164
  • Duration: 60 Min
Attend this webinar to learn how to be fully compliant with the USDA Final Rule on Bioengineered Food Disclosure, disclosure requirements in product labeling; disclosure options available to food manufacturers and distributors; symbols to be used and graphic requirements; and the timelines for compliance.
CD/Recorded
$299
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Recorded/CD
Calculations for Process and Product Capability

Calculations for Process and Product Capability

  • Speaker: Elaine Eisenbeisz
  • Product ID: 706629
  • Duration: 90 Min
Attendees of this webinar will learn specific concepts and formulas commonly used to measure the ability of a process to produce output within customers’ specification limits. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures and formulas to use for the various types of process data (attribute or variable).
CD/Recorded
$249
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