WEBINARS

 

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

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

webinar-speaker   Carlos M Aquino

webinar-time   120 Min

Product Id: 701991

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.

Recording Available

* Per Attendee $349

 

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

webinar-speaker   Norma Skolnik

webinar-time   60 Min

Product Id: 704371

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.

Recording Available

* Per Attendee $249

 

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

webinar-speaker   Carlos M Aquino

webinar-time   60 Min

Product Id: 705163

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.

Recording Available

 

TSCA Reform - Immediate Actions Required

webinar-speaker   Rose Passarella

webinar-time   60 Min

Product Id: 705036

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.

Recording Available

* Per Attendee $249

 

Project Risk Management

webinar-speaker   Mario Mosse

webinar-time   90 Min

Product Id: 705015

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.

Recording Available

* Per Attendee $229

 

Equipment Qualification Basics

webinar-speaker   Joy McElroy

webinar-time   90 Min

Product Id: 704403

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.

Recording Available

* Per Attendee $249

 

Selection and Management of Contract Vendors

webinar-speaker   Peggy Berry

webinar-time   90 Min

Product Id: 704884

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.

Recording Available

 

The FDA Compliance Enforcement Process

webinar-speaker   David L Chesney

webinar-time   90 Min

Product Id: 704913

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.

Recording Available

 

Blinding of Investigational Materials

webinar-speaker   Donald Levine

webinar-time   90 Min

Product Id: 703674

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.

Recording Available

* Per Attendee $50

 

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

webinar-speaker   David Lilienfeld

webinar-time   90 Min

Product Id: 703479

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.

Recording Available

* Per Attendee $229

 

Internal Auditing in Pharmaceutical Manufacturing - Lightning Rod & Steam Valve

webinar-speaker   Mitchell Ehrlich

webinar-time   60 Min

Product Id: 703465

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.

Recording Available

* Per Attendee $229

 

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

webinar-speaker   Shahbaz Shahbazi,Ray Bandziulis

webinar-time   75 Min

Product Id: 702614

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.

Recording Available

* Per Attendee $229

 

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

webinar-speaker   Charles R. McConachie

webinar-time   60 Min

Product Id: 702334

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.

Recording Available

* Per Attendee $229

 

Avoiding Failure to Investigate - Observations by Conducting Effective Investigations

webinar-speaker   Felicia Ford-Rice

webinar-time   49 Min

Product Id: 701933

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.

Recording Available

* Per Attendee $449

 

Appropriate and Lawful Off-Label Dissemination

webinar-speaker   Mark DuVal,Mark Gardner

webinar-time   70 Min

Product Id: 701550

Off-label dissemination procedure planning, review, audit as per the laws and enforcement environments and know what draws a prosecutor’s attention.

Recording Available

* Per Attendee $349

 

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

webinar-speaker   Paula Shadle

webinar-time   60 Min

Product Id: 701507

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.

Recording Available

* Per Attendee $299

 

 

 

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