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Home › Online Training ›Pharmaceutical Training ›  Crisis Management

Crisis Management Regulatory Compliance Training - Live Webinars, Recordings & CDs

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U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements and Cosmetics
4
/ Jun
Tuesday-2019

U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements and Cosmetics

  • Speaker: Norma Skolnik
  • Product ID: 704371
  • Duration: 60 Min
In order to market dietary supplements and OTC drugs in the U.S., reporting serious adverse events is required. It’s essential to understand these important FDA requirements to assure regulatory compliance and avoid an FDA warning letter or 483 audit issues.
* Per Attendee
$199
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Recorded/CD
How to Survive a DEA Inspection Series: Controlled Substances and Hospital Pharmacy

How to Survive a DEA Inspection Series: Controlled Substances and Hospital Pharmacy

  • Speaker: Carlos M Aquino
  • Product ID: 701991
  • Duration: 120 Min
This training will cover several recommendations to improve the hospital’s due diligence when administering and dispensing narcotic drugs in a hospital setting and what steps to take to detect and prevent the illicit use or diversion.
CD/Recorded
$349
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Recorded/CD
How to Survive a DEA Inspection Series: "Understanding a DEA Computation Chart for Manufacturers or FIND=FINE"

How to Survive a DEA Inspection Series: "Understanding a DEA Computation Chart for Manufacturers or FIND=FINE"

  • Speaker: Carlos M Aquino
  • Product ID: 705163
  • Duration: 60 Min
The presentation is tailored for those corporate leaders and employees of DEA registered manufacturers responsible for handling Schedules I through V controlled substances and List I regulated chemical products. This training will cover several recommendations to improve your methods of record-keeping required of DEA registrants.
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Recorded/CD
TSCA Reform - Immediate Actions Required

TSCA Reform - Immediate Actions Required

  • Speaker: Rose Passarella
  • Product ID: 705036
  • Duration: 60 Min
This webinar will provide an overview of the new law and major changes to Toxic Substances Control Act (TSCA). All chemical stakeholders doing business in the U.S. will need to understand the fundamental shifts in requirements, the new concepts and approaches that are introduced by the law, and the timetable that the U.S. Environmental Protection Agency (EPA) must follow in implementing the new law.
CD/Recorded
$249
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Recorded/CD
Project Risk Management

Project Risk Management

  • Speaker: Mario Mosse
  • Product ID: 705015
  • Duration: 90 Min
Project risk management includes the processes of conducting risk management planning, identification, analysis, action planning, and controlling risk on a project. This training program will analyze the objectives of project risk management - to increase the likelihood and impact of positive outcomes while decreasing the likelihood and impact of negative events affecting the success of the project.
CD/Recorded
$229
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Recorded/CD
Equipment Qualification Basics

Equipment Qualification Basics

  • Speaker: Joy McElroy
  • Product ID: 704403
  • Duration: 90 Min
This training program will list the documents required for equipment qualification and process validation and discuss how to manage documents appropriately. Attendees will gain insight into best practices for writing and maintaining a Validation Master Plan (VMP). The course will also discuss best practices for writing and executing sound protocols for equipment qualification (IQ, OQ, PQ) and process validation.
CD/Recorded
$249
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Recorded/CD
Selection and Management of Contract Vendors

Selection and Management of Contract Vendors

  • Speaker: Peggy Berry
  • Product ID: 704884
  • Duration: 90 Min
This webinar will discuss approaches to selecting vendors to perform manufacturing and testing activities as well as clinical study activities. The information obtained will enable implementation of an effective vendor selection program and a comprehensive vendor management and oversight program. The webinar will address aspects of requesting bids, performing audits, evaluating risks, and preparing plans and agreements for effective oversight and management.
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Recorded/CD
The FDA Compliance Enforcement Process

The FDA Compliance Enforcement Process

  • Speaker: David L Chesney
  • Product ID: 704913
  • Duration: 90 Min
This 90 mins webinar will provide a thorough understanding of the range of FDA enforcement options and the criteria the agency applies in deciding which to use.
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Recorded/CD
Blinding of Investigational Materials

Blinding of Investigational Materials

  • Speaker: Donald Levine
  • Product ID: 703674
  • Duration: 90 Min
This webinar will introduce attendees to the basics concepts and techniques of blinding of investigational drug products. It will also provide an understanding of the complexities of the work required to prepare blinded products for clinical trials.
CD/Recorded
$25
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Recorded/CD
Introduction of Post-Marketing Drug Safety Surveillance: Pharmacovigilance in FDA / CDER

Introduction of Post-Marketing Drug Safety Surveillance: Pharmacovigilance in FDA / CDER

  • Speaker: David Lilienfeld
  • Product ID: 703479
  • Duration: 90 Min
This pharmacovigilance webinar will provide attendees an understanding of post-marketing drug safety surveillance, its role in lifecycle management, and the practices and regulations governing its conduct. It will describe the structure of the pharmacovigilance world including the ICH, the FDA, CIOMS, MHW, and EudraVigilance.
CD/Recorded
$229
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Recorded/CD
Internal Auditing in Pharmaceutical Manufacturing - Lightning Rod & Steam Valve

Internal Auditing in Pharmaceutical Manufacturing - Lightning Rod & Steam Valve

  • Speaker: Mitchell Ehrlich
  • Product ID: 703465
  • Duration: 60 Min
This webinar will explain how to conduct an effective internal audit program. Attendees will learn the benefits of a well-designed and executed internal auditing program for GMP compliance enhancement, management informatics and for avoidance of whistleblower actions.
CD/Recorded
$229
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Recorded/CD
Product Complaint Investigations - The application of Lean Six Sigma methodology for U.S. FDA-Regulated Industries

Product Complaint Investigations - The application of Lean Six Sigma methodology for U.S. FDA-Regulated Industries

  • Speaker: Shahbaz Shahbazi,Ray Bandziulis
  • Product ID: 702614
  • Duration: 75 Min
This webinar will discuss the use of Lean Six Sigma methodology for product complaint investigations and offer a standardized approach for FDA regulated life science companies to follow whenever product complaint investigations are needed.
CD/Recorded
$229
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Recorded/CD
Unsolicited Drug and Device Off-Label Claims Via Social Media and Risk Management

Unsolicited Drug and Device Off-Label Claims Via Social Media and Risk Management

  • Speaker: Charles R. McConachie
  • Product ID: 702334
  • Duration: 60 Min
This course will provide necessary information to those in the drug and device manufacturing industries on how to best work with consumers and health professionals regarding off-label claims of relevant drugs and devices that arise from third parties or from the natural progression of social media.
CD/Recorded
$229
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Recorded/CD
Avoiding Failure to Investigate - Observations by Conducting Effective Investigations

Avoiding Failure to Investigate - Observations by Conducting Effective Investigations

  • Speaker: Felicia Ford-Rice
  • Product ID: 701933
  • Duration: 49 Min
This webinar will focus on the key attributes of an effective cGMP investigation, the role of management, employing quality control tools, CAPA effectiveness checks and Warning Letters associated with cGMP compliance. Attend this training and learn how you can avoid “Failure to Investigate" Observations by FDA.
CD/Recorded
$449
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Recorded/CD
Appropriate and Lawful Off-Label Dissemination

Appropriate and Lawful Off-Label Dissemination

  • Speaker: Mark DuVal,Mark Gardner
  • Product ID: 701550
  • Duration: 70 Min
Off-label dissemination procedure planning, review, audit as per the laws and enforcement environments and know what draws a prosecutor’s attention.
CD/Recorded
$349
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Recorded/CD
Supplier Qualification and Oversight: How to Cope with a Global Supply Chain

Supplier Qualification and Oversight: How to Cope with a Global Supply Chain

  • Speaker: Paula Shadle
  • Product ID: 701507
  • Duration: 60 Min
This supplier qualification training/Webinar will discuss on strategy to apply to QC testing and QA oversight, that helps to assure suitable quality of raw materials/excipients, and how to detecting fraud.
CD/Recorded
$299
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