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Home › Online Training ›FDA Training ›  FDA Audit and Inspection

FDA Audit and Inspections Regulatory Compliance Training - Live Webinars, Recordings & CDs

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Structuring and Conducting Risk-Based Internal cGMP Compliance Audits
3
/ Feb
Wednesday-2021

Structuring and Conducting Risk-Based Internal cGMP Compliance Audits

  • Speaker: John E Lincoln
  • Product ID: 701432
  • Duration: 60 Min
This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits.
* Per Attendee
$229
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Report Writing for Auditing Professionals
9
/ Feb
Tuesday-2021

Report Writing for Auditing Professionals

  • Speaker: Phil Vassallo
  • Product ID: 703814
  • Duration: 90 Min
Skilled auditors require a method that aligns what they experienced during the reviewing process with what they compose during the writing process. This report writing workshop will provide foundation resources that participants can continually turn to during intense, complex audit engagements.
* Per Attendee
$199
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Good Documentation Guideline (Chapter <1029> USP)
10
/ Feb
Wednesday-2021

Good Documentation Guideline (Chapter <1029> USP)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705130
  • Duration: 60 Min
This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
* Per Attendee
$229
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SaaS/Cloud Risk-Based Validation With Time-Saving Templates
10
/ Feb
Wednesday-2021

SaaS/Cloud Risk-Based Validation With Time-Saving Templates

  • Speaker: David Nettleton
  • Product ID: 701687
  • Duration: 90 Min
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
* Per Attendee
$249
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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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Recorded/CD
Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705583
  • Duration: 60 Min
In this webinar, we will discuss the definition, purpose, importance of GDP, General rules of GDP, GDP as it applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029>, and introduction “Good Documentation Guidelines”. We will also briefly introduce you to the European Union (EU) GDP, and its enforcement along with some observation samples from FDA.
CD/Recorded
$299
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Recorded/CD
Properly Investigating and Remediating OOS Results

Properly Investigating and Remediating OOS Results

  • Speaker: Danielle DeLucy
  • Product ID: 704351
  • Duration: 90 Min
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
CD/Recorded
$299
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Recorded/CD
How to Conduct Successful Supplier Audits

How to Conduct Successful Supplier Audits

  • Speaker: Danielle DeLucy
  • Product ID: 704499
  • Duration: 60 Min
This training program will provide participants with a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier can meet all your expectations.
CD/Recorded
$249
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Recorded/CD
Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

  • Speaker: Joy McElroy
  • Product ID: 704086
  • Duration: 120 Min
The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.
CD/Recorded
$349
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Recorded/CD
Introduction to Root Cause Investigation for CAPA

Introduction to Root Cause Investigation for CAPA

  • Speaker: Vanessa Lopez
  • Product ID: 704409
  • Duration: 60 Min
This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.
CD/Recorded
$299
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Recorded/CD
Root Cause Analysis - Getting to the Bottom of It

Root Cause Analysis - Getting to the Bottom of It

  • Speaker: John E Lincoln
  • Product ID: 701373
  • Duration: 90 Min
This failure investigation and root cause analysis training will present a repeatable methodology / defined systems, and simple tools that you can use to trace problems to their source and root cause. Attendees will get knowledge on Flow charts, Cause and Effect Diagrams, the 5 Whys, and other statistical tools to accomplish FI/RCA.
CD/Recorded
$299
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Recorded/CD
Surviving an FDA Sponsor Inspection - Training for Success

Surviving an FDA Sponsor Inspection - Training for Success

  • Speaker: Stephen Schwartz
  • Product ID: 704516
  • Duration: 105 Min
This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits.
CD/Recorded
$429
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Recorded/CD
4-Hr Virtual Training: How to Respond to an FDA Investigation

4-Hr Virtual Training: How to Respond to an FDA Investigation

  • Speaker: Joy McElroy
  • Product ID: 704549
  • Duration: 4 hrs
This FDA investigation training program will deconstruct best practices for handling unannounced FDA visits, responding to a 483 or a warning letter, and the effect of an FDA investigation. The program will also discuss basic concepts that should be employed by everyone regulated by the FDA and define processes for preparing for FDA audits.
CD/Recorded
$449
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Recorded/CD
Best Practices for an Effective Cleaning Validation Program

Best Practices for an Effective Cleaning Validation Program

  • Speaker: Joy McElroy
  • Product ID: 704329
  • Duration: 60 Min
This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful.
CD/Recorded
$299
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Recorded/CD
How to Survive a DEA Inspection Series: For DEA Registered Analytical Labs and Research Facilities

How to Survive a DEA Inspection Series: For DEA Registered Analytical Labs and Research Facilities

  • Speaker: Carlos M Aquino
  • Product ID: 704617
  • Duration: 60 Min
The training program will cover DEA record-keeping requirements and effective security that a DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods.
CD/Recorded
$299
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Recorded/CD
New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products

New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products

  • Speaker: Angela Bazigos
  • Product ID: 704529
  • Duration: 90 Min
This training program will examine the approval process for drugs, biologics and devices and elaborate FDA submission requirements and guidances. It will also discuss electronic regulatory submission and gateway for FDA and FDA eCTD guidance and specifications.
CD/Recorded
$249
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Recorded/CD
The Most Serious FDA 483s - How to Avoid Them

The Most Serious FDA 483s - How to Avoid Them

  • Speaker: John E Lincoln
  • Product ID: 702766
  • Duration: 90 Min
This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.
CD/Recorded
$299
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Recorded/CD
The FDA Inspection Process: From SOP to 483

The FDA Inspection Process: From SOP to 483

  • Speaker: Jeff Kasoff
  • Product ID: 700269
  • Duration: 60 Min
This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA inspection. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.
CD/Recorded
$375
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Recorded/CD
Learning from Recent FDA Warning Letters Related to Part 11 and Computer Validation

Learning from Recent FDA Warning Letters Related to Part 11 and Computer Validation

  • Speaker: Dr. Ludwig Huber
  • Product ID: 701547
  • Duration: 75 Min
This webinar focuses on 21 CFR Part 11 requirements stipulated by the FDA. It will also guide attendees on writing corrective and preventive action plans as follow up to 483s.
CD/Recorded
$249
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Recorded/CD
How to undergo an FDA Inspection Successfully

How to undergo an FDA Inspection Successfully

  • Speaker: Marie Morin
  • Product ID: 705170
  • Duration: 90 Min
This webinar will discuss best practices for preparing for an international announced inspection as well as how to be always prepared for those in the US who may be inspected at any time. It also discusses the various roles of the persons who will be assisting during the inspection and suggests how to organize support personnel to aid in keeping the inspection going smoothly and identify and address issues before FDA sees them.
CD/Recorded
$249
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