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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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The Brazilian Reimbursement System
25
/ Apr
Thursday-2019

The Brazilian Reimbursement System

  • Speaker: Eliana Silva de Moraes
  • Product ID: 706031
  • Duration: 90 Min
In this webinar attendees will learn the legal and regulatory framework for reimbursement system in Brazil to have better and effective result when marketing with medical and drug product in Brazil.
* Per Attendee
$249
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Human Error Investigations, Root Cause Determination and CAPA Effectiveness
25
/ Apr
Thursday-2019

Human Error Investigations, Root Cause Determination and CAPA Effectiveness

  • Speaker: Ginette M Collazo
  • Product ID: 704314
  • Duration: 90 Min
This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations.
* Per Attendee
$249
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Quality Management and Quality Audit According to GxP/GMP Requirements
26
/ Apr
Friday-2019

Quality Management and Quality Audit According to GxP/GMP Requirements

  • Speaker: Eleonora Babayants
  • Product ID: 705633
  • Duration: 90 Min
In this webinar, the framework of GxP/GMP regulations, quality management system, and quality audit will be described. Attendees will Learn about different types of quality audits and how to properly prepare for them, what actions you need to take to ensure that your organization will pass an audit.
* Per Attendee
$249
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Good Documentation Guideline (Chapter <1029> USP)
26
/ Apr
Friday-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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Handling OOS Test Results and Completing Robust Investigations
2
/ May
Thursday-2019

Handling OOS Test Results and Completing Robust Investigations

  • 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.
* Per Attendee
$199
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Establishing a Robust Supplier Management Program
9
/ May
Thursday-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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Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
9
/ May
Thursday-2019

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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Pre-Formulation and Formulation Development of Small and Large Molecules for a Lyophilized Product
9
/ May
Thursday-2019

Pre-Formulation and Formulation Development of Small and Large Molecules for a Lyophilized Product

  • Speaker: J. Jeff Schwegman
  • Product ID: 702305
  • Duration: 90 Min
This webinar on lyophilization technology will provide you the understanding physical properties of formulated products through the use of very specialized analytical techniques. Also attendees will learn pre-formulation assessment, pre-formulation studies including choosing an optimal solution pH and buffer system, solubility enhancement, controlling oxidation, and bulking agents.
* Per Attendee
$199
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How to Ensure Your Foreign Vendors are FDA Compliant: Conducting Vendor Audits, Monitoring, and Using Checklists
14
/ May
Tuesday-2019

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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Label Claims for food, Probiotics and Cosmetic products in Brazilian Regulatory System
15
/ May
Wednesday-2019

Label Claims for food, Probiotics and Cosmetic products in Brazilian Regulatory System

  • Speaker: Eliana Silva de Moraes
  • Product ID: 706032
  • Duration: 90 Min
In this webinar attendees will learn the brazilian labeling requirement for food, cosmetic and probiotics products, Also attendees will gain a complete understanding of claims regulation for food, cosmetic and probiotics according with the local legislation.
* Per Attendee
$249
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Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry
21
/ May
Tuesday-2019

Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry

  • Speaker: Robert J Russell
  • Product ID: 702038
  • Duration: 90 Min
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America [Brazil, Mexico, Argentina]. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
* Per Attendee
$249
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Toxic Impurities in Active Pharmaceutical Ingredients
23
/ May
Thursday-2019

Toxic Impurities in Active Pharmaceutical Ingredients

  • Speaker: Loren Gelber
  • Product ID: 706056
  • Duration: 75 Min
The recent recalls of sartan antihypertensives due to the presence of nitrosamines may suggest increased attention from FDA to toxic impurities in drug products from active pharmaceutical ingredients. The public information about the limits of toxic impurities and about nitrosamines in sartans will be discussed and possible similar situations reviewed in this webinar.
* Per Attendee
$249
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Technical Writing in an Industrial Environment
24
/ May
Friday-2019

Technical Writing in an Industrial Environment

  • Speaker: Robert Peoples
  • Product ID: 706058
  • Duration: 60 Min
Attend this webinar to learn the logical, fast and simple process of how to easily write any document that your company requires. Explore how to organize collected information, write the document and address the comments from reviewers and approvers.
* Per Attendee
$229
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GxP/GMP Requirements and its Consequences for Documentation and Information Technology Systems
24
/ May
Friday-2019

GxP/GMP Requirements and its Consequences for Documentation and Information Technology Systems

  • Speaker: Eleonora Babayants
  • Product ID: 706039
  • Duration: 90 Min
Attend this webinar to learn the connection between GxP/GMP with document control and IT systems. Attendees will learn how to manage control documents to pass quality audit and information technology systems in compliance with GxP/GMP requirements.
* Per Attendee
$249
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How to Establish and Maintain a Compliant, Practical Clinical Quality Management System in a Changing Organization
28
/ May
Tuesday-2019

How to Establish and Maintain a Compliant, Practical Clinical Quality Management System in a Changing Organization

  • Speaker: Penelope Przekop
  • Product ID: 706062
  • Duration: 90 Min
Global regulators require your company to have a robust QMS, regardless of company size, situation, or outsourcing strategy. In this webinar, learn how to establish and maintain a compliant and practical Clinical Quality System during process improvement efforts and/or company growth that can be clearly understood, communicated, and embraced from the top to bottom of your organization.
* Per Attendee
$249
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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 you will gain a basic to moderate knowledge of definition, purpose, importance of GDP, General rules of GDP, GDP as applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029> introduction “Good Documentation Guidelines”, A very brief introduction to European Union (EU) GDP, and finally its enforcement along with some observation samples from FDA.
CD/Recorded
$299
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Recorded/CD
21 CFR 11 Compliance for Excel Spreadsheet

21 CFR 11 Compliance for Excel Spreadsheet

  • Speaker: Angela Bazigos
  • Product ID: 702450
  • Duration: 90 Min
This Excel spreadsheet compliance training will outline the FDA requirements for Excel spreadsheets used in regulated environments and provide guidance on 21 CFR Part 11 validation.
CD/Recorded
$249
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Recorded/CD
Project Management for Auditors - Improving audit productivity for GCP, GMP and GLP

Project Management for Auditors - Improving audit productivity for GCP, GMP and GLP

  • Speaker: Laura Brown
  • Product ID: 701982
  • Duration: 60 Min
This Project Management training for Auditors will help you understand how to apply project management principles to auditing to ensure efficient and effective quality assurance of drug development.
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
Software Validation and its 11 Key Documents

Software Validation and its 11 Key Documents

  • Speaker: John E Lincoln
  • Product ID: 703097
  • Duration: 90 Min
This webinar focuses on the verification and validation planning and execution of software, after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) and the growing field of "cloud"-based software. A suggested FDA model (mandated for submissions) will be evaluated, implemented, with V&V documentation and test case examples. Also attendees will learn the most recent issues the FDA has had in this area, and remediation approaches.
CD/Recorded
$299
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