WEBINARS

 

Compliance Training Webinars for Regulated Industries

Annual Analytical Laboratory Data Integrity Training

webinar-speaker   Nanda Subbarao

webinar-time  

Product Id: 705326

This webinar will address the key elements of regulatory expectations for analytical laboratory data integrity. It will teach best practices to avoid 483s and warning letters issued by FDA related to data integrity issues.

Recording Available

 

Implementing Robust Supply Chains

webinar-speaker   Chris Tsai,Ron Crabtree,Buddy Baker,Betty Lane,Paula Shadle,Norman Katz,Edwin L Bills

webinar-time   8.5 hrs

Product Id: 702793

This comprehensive training package of 7 courses is aimed at helping companies to be compliant and streamline the robust supply chain planning, processes, risk management etc by maintaining regulatory guidelines.

Recording Available

* Per Attendee $1649

 

Pack of two courses: The essentials of Food and Drug Administration Medical Device Regulations: A primer for manufacturers and suppliers

webinar-speaker   Edwin L Bills

webinar-time  

Product Id: 700957

This pack of 2 courses contains the essentials of FDA Medical Device regulations.

Recording Available

* Per Attendee $349

 

Avoiding FDA observations: Do's and Don'ts during Laboratory Inspections

webinar-speaker   Kim Huynh-Ba

webinar-time  

Product Id: 703278

This training will provide the attendees best practices for handling FDA inspections to avoid form 483 and Warning Letters.

Recording Available

 

How to Buy COTS Software, and Audit and Validate Vendors

webinar-speaker   David Nettleton

webinar-time  

Product Id: 703820

This training program will focus on instructing attendees on best practices for buying COTS (Commercial Off-The-Shelf) software and to evaluate a software vendor. It will also highlight key data and systems subject to Part 11, and list requirements for IT, SaaS, and cloud hosting.

Recording Available

 

Key Factors to Develop an Effective CAPA System

webinar-speaker   Kim Huynh-Ba

webinar-time  

Product Id: 703320

This training will focus on the regulatory requirements for a Corrective and Preventive Actions (CAPA) system. Attendees will learn how to develop an effective CAPA system.

Recording Available

 

Understanding the JPAL (Japanese Pharmaceutical Affairs Law): Comprehensive Training Package (5 Courses)

webinar-speaker   Phil Smart

webinar-time  

Product Id: 701294

This package of 5 training courses is meant to give an exhaustive and in-depth understanding of the Japanese Pharmaceutical Affairs Law (PAL) including the 2005 revisions which are now in force.

Recording Available

 

Understanding and Preparing for System Based Inspections: Comprehensive Training Package (6 Courses)

webinar-speaker   Robert Ferer

webinar-time  

Product Id: 701357

This System Based Inspections training will give you a comprehensive overview of all aspects of systems based inspections covering Quality, Facilities and Equipment, Materials, Production, Packaging and Labeling and Laboratory Control.

Recording Available

 

 

 

GMP Requirements for Validation and Re-Validation of Analytical Procedures

webinar-speaker   Kim Huynh-Ba

webinar-time  

Product Id: 703041

This webinar will explain the cGMP and ICH validation requirements for analytical procedures and discuss key factors that would affect validation process of analytical procedures. It will review the differences between validation and re-validation plan.

Recording Available

 

Hurricane Safety and Survival Tips - Severe Weather Precautions

webinar-speaker   John J Meola

webinar-time  

Product Id: 705470

This webinar will review the most critical safety elements associated with planning for, surviving and recovering from natural disasters, such as Hurricane Harvey we have seen recently in Texas. Learn how to protect yourself, your family and your employees, what to expect, and how to minimize the disruption from severe weather events.

Recording Available

 

Quality Metrics and the Issues with the FDA’s Revision Draft Guidance Quality Metrics Data

webinar-speaker   Barry A Friedman

webinar-time  

Product Id: 705452

This webinar will discuss the main issues with FDA’s revised draft guidance on submission of quality metrics data. It will also cover the most common observations that the FDA issues within the warning letter and how these can impact your organization.

Recording Available

 

Stability Program for Pharmaceuticals and Biologics

webinar-speaker   Nanda Subbarao

webinar-time  

Product Id: 705455

This webinar will provide an overview of the stability studies required for pharmaceuticals and biologics. It will also provide a summary of recent developments in the industry and regulatory requirements in this field.

Recording Available

 

Implementing and Auditing Business Continuity Plans

webinar-speaker   Michael C Redmond

webinar-time  

Product Id: 704821

This training program will provide an overview on how to create a business continuity audit plan that is effective and in line with the company's objectives. It will help attendees understand regulations, standards and requirements pertinent to business continuity audits as well. The webinar will define the risks or threats to the success of an audit plan and train attendees on how to test the controls in place to determine whether or not those risks are acceptable.

Recording Available

* Per Attendee $249

 

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

 

 

 

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