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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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How to write SOP's that Avoid Human Error
17
/ Oct
Thursday-2019

How to write SOP's that Avoid Human Error

  • Speaker: Ginette M Collazo
  • Product ID: 704418
  • Duration: 90 Min
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
* Per Attendee
$249
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The Brazilian Pharmacovigilance System
22
/ Oct
Tuesday-2019

The Brazilian Pharmacovigilance System

  • Speaker: Eliana Silva de Moraes
  • Product ID: 706204
  • Duration: 90 Min
Attend this webinar to learn about the Brazilian pharmacovigilance regulation, risk management, the Health Brazilian Constitution Rights. Learn about labeling, safety reports, harmonization process, benefit-risk legal concept, reciprocity, and more.
* Per Attendee
$249
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Establishing a Robust Supplier Management Program
22
/ Oct
Tuesday-2019

Establishing a Robust Supplier Management Program

  • Speaker: Kelly Thomas
  • Product ID: 706055
  • Duration: 90 Min
This course will review regulatory guidance governing Suppliers and the elements of a robust supplier management program including, initial qualification, supplier performance monitoring, and scorecards, supplier audit options, and quality agreement requirements. It will discuss how to utilize risk-based quality tools to determine supplier classification with a risk assessment example. Recent FDA audit findings will also be reviewed.
* Per Attendee
$249
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Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)
24
/ Oct
Thursday-2019

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.
* Per Attendee
$299
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Good Documentation Guideline (Chapter <1029> USP)
24
/ Oct
Thursday-2019

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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How to Develop, Implement and Manage an Effective Change Control Program
31
/ Oct
Thursday-2019

How to Develop, Implement and Manage an Effective Change Control Program

  • Speaker: Kelly Thomas
  • Product ID: 705909
  • Duration: 90 Min
This Change Control training program will discuss regulatory expectations from the FDA, EU and ICH perspective, review all the required components of a thorough Change Control program; as well as, discuss the elements regarding successful management an effective Change Control system.
* Per Attendee
$249
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The Mindset of an FDA Employee
1
/ Nov
Friday-2019

The Mindset of an FDA Employee

  • Speaker: Larry Stevens
  • Product ID: 706174
  • Duration: 60 Min
If you develop or manufacture a product regulated by FDA you will need to interact with FDA employees. It is important to interact with the FDA employee in the most productive manner. But there is a variable you must deal with that will determine how productive your interaction is. The variable is the FDA employee. That is the purpose of this webinar.
* Per Attendee
$229
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Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
5
/ Nov
Tuesday-2019

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

  • 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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Fishbone Diagramming
6
/ Nov
Wednesday-2019

Fishbone Diagramming

  • Speaker: Michael Abitz
  • Product ID: 705338
  • Duration: 90 Min
This webinar will teach you how to identify potential process problems and avoid process interactions through effective process mapping. It will cover steps to create a fishbone diagram including its purpose, advantages and how to present it.
* Per Attendee
$199
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Aseptic Processing Overview and Validation
11
/ Nov
Monday-2019

Aseptic Processing Overview and Validation

  • Speaker: Kelly Thomas
  • Product ID: 706212
  • Duration: 90 Min
This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.
* Per Attendee
$249
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Writing and Revising SOPs for Increased Operational Efficiency
12
/ Nov
Tuesday-2019

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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Human Error and Cognitive Load: How to Reduce Memory and Attention Failures
12
/ Nov
Tuesday-2019

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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Conducting Successful FDA Meetings
15
/ Nov
Friday-2019

Conducting Successful FDA Meetings

  • Speaker: Larry Stevens
  • Product ID: 706198
  • Duration: 60 Min
If you develop or manufacture a product regulated by FDA you will need to interact with FDA employees. Knowing what makes FDA employees the way they are, will help immensely in understanding how to deal with FDA.
* Per Attendee
$229
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Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities
19
/ Nov
Tuesday-2019

Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

  • Speaker: Vanessa Lopez
  • Product ID: 704758
  • Duration: 90 Min
This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources, and details will be furnished on the interrelationships regarding complaint handling/change control/adverse event reporting/and recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.
* Per Attendee
$249
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Best Practices for an Effective Cleaning Validation Program
19
/ Nov
Tuesday-2019

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.
* Per Attendee
$229
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Recorded/CD
Process Capability for Normal and Non-Normal Data (Focus: Process Stability, Capability and Cp, Cpk, Pp, Ppk, Cpm)

Process Capability for Normal and Non-Normal Data (Focus: Process Stability, Capability and Cp, Cpk, Pp, Ppk, Cpm)

  • Speaker: Steven Wachs
  • Product ID: 705020
  • Duration: 90 Min
This webinar discusses methods for estimating process capability for both normal and non-normal data. Methods include estimating the proportion of defective products that may be produced as well as the calculation and use of common process capability indices (e.g. Cpk and Ppk). Process Capability assessments are discussed in the overall context of quality improvement/management.
CD/Recorded
$299
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Recorded/CD
Occupational Safety of Nanomaterials

Occupational Safety of Nanomaterials

  • Speaker: Rob MacCuspie
  • Product ID: 706203
  • Duration: 60 Min
This webinar will discuss how to use tiered approaches to evaluate the occupational safety risks of nanomaterials handling and processing for both laboratory environments and production environments, as well as common risk mitigation approaches.
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Recorded/CD
Quality Assurance for Continuous Manufacturing of Small Molecule, Oral Dosage Products

Quality Assurance for Continuous Manufacturing of Small Molecule, Oral Dosage Products

  • Speaker: Peggy Kwoka
  • Product ID: 706201
  • Duration: 90 Min
The expectations for quality remain the same for batches produced continually vs. bath-to-batch. However, the quality unit must transition to a very different control strategy to ensure product quality. This webinar will discuss quality and compliance considerations for continuous manufacturing as per the FDA draft Guidance for Industry (Quality Considerations for Continuous Manufacturing, February 2019) and with input from other FDA Guidances and ICH documents. The content is intended for small molecule solid oral drug products, but concepts can be applied to other products.
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Recorded/CD
Effective (and FDA Compliant) Management Reviews

Effective (and FDA Compliant) Management Reviews

  • Speaker: Larry Stevens
  • Product ID: 705646
  • Duration: 60 Min
So, we perform Management Reviews because FDA regulations require it? In fact, if you are performing management reviews only to satisfy FDA, you may be complying but you are probably wasting your time. Effective management reviews should have tangible value to the senior executives performing the review. In this online training, we will review how to perform effective management reviews that will assist in the effective management of the company.
CD/Recorded
$299
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Recorded/CD
The Relationship of Designing an Effective Environmental Monitoring Program and Determining a Cleanroom State of Control

The Relationship of Designing an Effective Environmental Monitoring Program and Determining a Cleanroom State of Control

  • Speaker: Charity Ogunsanya
  • Product ID: 706193
  • Duration: 90 Min
This course will discuss the various steps associated with the EM program from the Phases, through Validation, Implementation, Procedural Steps, Documentation Practices, Data Management, Trending of Data, EM Excursion and the relationship of the cleanroom state of control and product impact and analysis.
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