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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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Batch Record Review and Product Release
23
/ Sep
Wednesday-2020

Batch Record Review and Product Release

  • Speaker: Danielle DeLucy
  • Product ID: 705921
  • Duration: 60 Min
In this webinar attendees will learn the fundamentals for reviewing batch records in a pharmaceuticals, biologics and medical devices environment. Attendees will hear about the proper training that must be demonstrated before one is considered a suitable reviewer of these critical documents and also they will learn how to react to discrepancies found in these records.
* Per Attendee
$229
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Writing Effective IQ, OQ,PQ Protocols for Equipment Qualification
24
/ Sep
Thursday-2020

Writing Effective IQ, OQ,PQ Protocols for Equipment Qualification

  • Speaker: Joy McElroy
  • Product ID: 705763
  • Duration: 90 Min
This equipment qualification webinar will discuss the requirements for IQ, OQ, and PQ protocols. It will train about the various components of each protocol, Proper language for documenting qualification testing including how to Collect data, conduct tests, and obtaining all necessary documents.
* Per Attendee
$249
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Medical Device Industry Trends for Computer Systems Regulated by FDA
28
/ Sep
Monday-2020

Medical Device Industry Trends for Computer Systems Regulated by FDA

  • Speaker: Carolyn Troiano
  • Product ID: 706334
  • Duration: 90 Min
FDA requires that all computer systems used to produce, manage and report data for “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.
* Per Attendee
$249
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Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
29
/ Sep
Tuesday-2020

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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Process Mapping for Risk-Based P&PC Using Lean Six Sigma and HACCP
30
/ Sep
Wednesday-2020

Process Mapping for Risk-Based P&PC Using Lean Six Sigma and HACCP

  • Speaker: John E Lincoln
  • Product ID: 700817
  • Duration: 60 Min
This webinar will discuss the basic principles of P&PC, specifically as required by the FDA. Also attendees will learn the ISO 13485 and risk analysis / management requirements to evaluate the chief areas of an FDA CGMP compliance inspection / audit to locate areas for implementation and improvement in P&PC.
* Per Attendee
$329
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How to Ensure Your Foreign Vendors are FDA Compliant: Conducting Vendor Audits, Monitoring, and Using Checklists
7
/ Oct
Wednesday-2020

How to Ensure Your Foreign Vendors are FDA Compliant: Conducting Vendor Audits, Monitoring, and Using Checklists

  • Speaker: Joy McElroy
  • Product ID: 705735
  • Duration: 90 Min
This webinar will give information on auditing foreign vendors for FDA compliance. It will discuss initiating audits, planning and preparing vendor audits, as well as, monitoring foreign vendor compliance. This webinar will provide FDA guidance on foreign vendor expectations, what to do and what not to upon selecting a foreign vendor. It will also provide audit formats and checklists for ensuring a foreign vendor is qualified.
* Per Attendee
$249
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Implementation and Management of GMP Data Integrity
7
/ Oct
Wednesday-2020

Implementation and Management of GMP Data Integrity

  • Speaker: Danielle DeLucy
  • Product ID: 705029
  • Duration: 90 Min
Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.
* Per Attendee
$249
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FDA Compliance and Enforcement Trends focused on Data Integrity
15
/ Oct
Thursday-2020

FDA Compliance and Enforcement Trends focused on Data Integrity

  • Speaker: Carolyn Troiano
  • Product ID: 706353
  • 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.
* Per Attendee
$229
View Details
Effective Line Clearance - Prevent Product Holds and Recalls the Easy Way
16
/ Oct
Friday-2020

Effective Line Clearance - Prevent Product Holds and Recalls the Easy Way

  • Speaker: Charles H Paul
  • Product ID: 706539
  • Duration: 90 Min
Within the Pharmaceutical Industry, the changeover from one product to another on a filling/packaging line, although relatively a simple concept, has significant implications from a regulatory standpoint if cross-contamination is permitted to occur. Preventing cross-contamination requires a precise accountable process to be properly executed.
* Per Attendee
$349
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SaaS/Cloud Risk-Based Validation With Time-Saving Templates
20
/ Oct
Tuesday-2020

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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FDA Modernization and Restructuring of the SDLC for Computer System Validation (CSV) and Compliance
21
/ Oct
Wednesday-2020

FDA Modernization and Restructuring of the SDLC for Computer System Validation (CSV) and Compliance

  • Speaker: Carolyn Troiano
  • Product ID: 706561
  • Duration: 90 Min
As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed to assure data integrity is maintained. This webinar will focus on the efforts by FDA to modernize their own technology infrastructure, and what this means to industry. We will cover the Technology Modernization Action Plan (TMAP) that has been launched by FDA for this purpose and discuss specific actions that are planned and in progress.
* Per Attendee
$249
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The 6 Most Common Problems in FDA Software Validation and Verification
27
/ Oct
Tuesday-2020

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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The Nutraceutical / Dietary Supplements CGMPs per 21 CFR 111
27
/ Oct
Tuesday-2020

The Nutraceutical / Dietary Supplements CGMPs per 21 CFR 111

  • Speaker: John E Lincoln
  • Product ID: 706360
  • Duration: 60 Min
This webinar will evaluate the chief areas of the Dietary Supplements FDA CGMP compliance requirements as required by in 21 CFR 111, the US Law – this and related regulations mandate a ‘total quality system’ -- from customer requirements thru development, production, to customer use/feedback. Labeling requirements will also be discussed, including those uniquely geared to nutraceuticals. The steps resulting in the present FDA regulatory requirements will be reviewed. This webinar can also be a significant part of meeting a company’s annual CGMP training requirement (if properly supplemented and documented) for a neutraceutical company.
* Per Attendee
$229
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FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More
28
/ Oct
Wednesday-2020

FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

  • Speaker: Danielle DeLucy
  • Product ID: 704659
  • Duration: 60 Min
The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.
* Per Attendee
$229
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21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures
3
/ Nov
Tuesday-2020

21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures

  • Speaker:
  • Product ID: 706563
  • Duration: 90 Min
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
* Per Attendee
$249
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Recorded/CD
Drug Manufacturing Inspection Part III

Drug Manufacturing Inspection Part III

  • Speaker: Vanessa Lopez
  • Product ID: 706259
  • Duration: 120 Min
Attend this course to prepare for and understand what will happen during a Drug Manufacturing Inspection for Surveillance Inspections. It will explain the FDA criteria to perform a For Cause Inspection.
CD/Recorded
$349
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Recorded/CD
FDA Inspections: Understanding the Core Elements – Part I

FDA Inspections: Understanding the Core Elements – Part I

  • Speaker: Vanessa Lopez
  • Product ID: 706256
  • Duration: 120 Min
Attend this course to learn the rationale, strategies and flow on how to plan for an FDA inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.
CD/Recorded
$349
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Recorded/CD
How to Prepare a Standard Operating Procedure (SOP)?

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.
CD/Recorded
$299
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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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