WEBINARS

 

Compliance Training Webinars for Regulated Industries

Developing a Highly Effective Enterprise Risk Management Program

webinar-speaker   Michael C Redmond

webinar-time  

Product Id: 704827

This webinar highlights the importance of an effective ERM program in project management and risk assessment. Attendees will learn how to implement a viable ERM program including documenting and testing it.

Recording Available

 

Managing your GMP Quality Control (QC) Labs in Compliance with FDA Regulations

webinar-speaker   Kim Huynh-Ba

webinar-time  

Product Id: 705081

This webinar will discuss the common deficiencies in relation to compliance and validation issues that typically found with pharmaceutical Quality Control labs.

Recording Available

 

Design Validation Protocol and Acceptance Criteria for Chromatographic Methods to Meet ICH Requirements

webinar-speaker   Kim Huynh-Ba

webinar-time  

Product Id: 701594

This webinar will discuss how to write validation protocol and determine acceptance criteria. It will also explain the systematic approach to validate analytical procedures.

Recording Available

 

The New Part 11 Inspections: Requirements for Validation and SaaS/Cloud Applications

webinar-speaker   David Nettleton

webinar-time  

Product Id: 704734

This training program will identify data and systems subject to Part 11 and Annex 11. It will also decode what the regulations mean and illustrate the current computer system industry standards for security, data transfer, and audit trails.

Recording Available

 

Studies to Support Temperature Excursions and Shipping of Pharmaceutical Products

webinar-speaker   Kim Huynh-Ba

webinar-time  

Product Id: 704770

Upon completion of this training program, attendees will learn key factors that would affect the shipping and distribution of drug products. One must understand the product stability profile, typical environmental conditions for storage and anticipating environmental extremes for distribution. These data will be necessary to design shipping conditions in order to maintain quality of the drug product through expiry.

Recording Available

 

Establish an Effective Change Management Process for Stability Studies

webinar-speaker   Kim Huynh-Ba

webinar-time  

Product Id: 704085

Upon completion of this training program, attendees will learn key elements of a change management process, identify key indicators of change and learn the regulatory requirements for change control. This session will also discuss different observations due to the lack of effective change control program.

Recording Available

 

Webinars Series on Water System Compliance for Consumer Products, Medical Devices, Diagnostics, Pharmaceuticals, and Biologics

webinar-speaker   T.C Soli

webinar-time  

Product Id: 701351

This Water system compliance training will give you a comprehensive knowledge about water system compliance with relation to Microbial Quality Problems, Microbial Testing, Endotoxin control, Sanitization, Water system validation.

Recording Available

* Per Attendee $799

 

Annual GLP Refresher Course - 4 Hour Virtual Training

webinar-speaker   Nanda Subbarao

webinar-time  

Product Id: 704893

An Annual GLP training is a requirement for all personnel involved in Good Laboratory Practices (GLP) studies. The webinar course serves both as an initial training for new employees, new to GLP concepts will serving as a refresher course for experienced senior employees. The webinar provides an overview of the GLP to remind the attendees of the regulatory requirements for organizations in which bioanalytical testing is conducted.

Recording Available

 

Complying with FLSA - How to Determine Exempt Status & Calculate Overtime Correctly

webinar-speaker   Susan Fahey Desmond

webinar-time  

Product Id: 702717

This webinar on employee overtime calculation will help you understand what is “time worked”, exempt versus non-exempt status and how to calculate your employees' overtime correctly so to avoid these costly suits.

Recording Available

 

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences PART I & PART II

webinar-speaker   Robert J Russell

webinar-time  

Product Id: 701349

This JAPAN Regulatory compliance training is designed to provide an overview of the regulatory environment in Japan with respect to regulatory filings and registrations.

Recording Available

* Per Attendee $399

 

Recording Available

* Per Attendee $835

 

Webinar - Latin America – Understanding Regulatory Compliance Requirements Across Life Science Industry PART I & PART II

webinar-speaker   Robert J Russell

webinar-time  

Product Id: 701350

This Latin America Regulatory compliance requirement training/webinar will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.

Recording Available

* Per Attendee $299

 

Japanese PAL – JPAL Technical, cultural and language challenges when dealing with MAH, PMDA, Distributors and Customers

webinar-speaker   Phil Smart

webinar-time  

Product Id: 701292

This (JPAL) Japanese Pharmaceutical Affairs Law training will go into the unique challenges facing the Foreign Manufacturer when working with the Japanese.

Recording Available

 

FDA Inspection Primer - Comprehensive Training Course Package (5 Courses)

webinar-speaker   Martha Bennett ,Dr. Ludwig Huber,Jeff Kasoff,John E Lincoln,David Dills

webinar-time  

Product Id: 702294

This comprehensive FDA inspection training package consists of five training webinar recordings covering everything from preparing for FDA inspections to responding to FDA Form 483s and warning letters.

Recording Available

* Per Attendee $899

 

Fix Your Supply Chain Compliance Nightmare: Complimentary Webinar

webinar-speaker   Craig Isaacs

webinar-time  

Product Id: 704565

This webinar training will explain how to efficiently manage third-party and supply chain risk with the Common Controls Hub.

Third-party and supply chain compliance risk management is mandated for most organizations. However distributing, reporting, and tracking of adherence to control lists is so painful that many organizations do not perform due diligence at all or with the necessary frequency. Participants will learn how to self-assess their compliance and Internal controls.

Recording Available

 

21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s

webinar-speaker   David Nettleton

webinar-time  

Product Id: 704533

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).

Recording Available

 

Current Regulatory Requirements for Aseptically Produced Products

webinar-speaker   Kenneth Christie

webinar-time  

Product Id: 704791

The manufacture of sterile products and the risk they represent to the public is always on the fore front of inspectors during regulatory audits. As a result, the manufacture of sterile products require a high degree of control of incoming materials, the manufacturing process and the control of personnel to name a few. A weakness in any of these items can jeopardize the sterility assurance of the final product. This training program will highlight and summarize the following main components relating to current validation requirements for sterile products and include the following; review of the current regulations and guidance documents, the typical expectations when aseptic processing is involved, the expectations for protocols used to document the qualification of associated equipment, utilities and processes, and recently cited regulatory deficiencies.

Recording Available

 

HIPAA Compliance for Electronic Records

webinar-speaker   David Nettleton

webinar-time  

Product Id: 704422

This HIPAA training program will highlight electronic record security regulations including requirements for security, data transfer, audit trails, electronic signatures, digital pens, and biometric signatures.

Recording Available

 

Establish Change Control for Pharmaceutical Stability Program

webinar-speaker   Kim Huynh-Ba

webinar-time  

Product Id: 702968

This webinar on pharmaceutical stability program will discuss the types of CMC changes in the life cycle of a pharmaceutical product and how it affects the stability program.

Recording Available

 

Full Day Virtual Seminar : Annual GLP Refresher Webinar

webinar-speaker   Nanda Subbarao

webinar-time  

Product Id: 701862

Recording Available

 

 

 

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