Microsoft Word and Excel in FDA Regulated Industries: Pack of Four Training Courses
Chris Whalley,Dr. Ludwig Huber
4 hrs
Product Id: 700263
Validation and use of Microsoft Excel Spreadsheets, Good documentation practices, Using Styles in Microsoft Word, Reducing the cost of creating documents. This pack of four training courses provides 4 hours of traning on validation and use of Microsoft Excel Spreadsheets, good documentation practices, using Styles in Microsoft Word, and reducing the cost of creating documents in FDA Regulated Industries.
The 6 Most Common Problems in FDA Software Validation and Verification
David Nettleton
Product Id: 705582
This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
Best Practices for Conducting OOS Investigations (in Pharmaceutical Laboratories)
Nanda Subbarao
Product Id: 701487
This 90-minute webinar on laboratory OOS investigations will review the regulatory requirements for an OOS Investigation. You will learn common regulatory pitfalls and how to structure an Investigation report that satisfactorily documents the investigation.
Use Risk Assessment to Reduce Validation Time for 21 CFR Part 11
David Nettleton
Product Id: 701584
Get a detailed understanding of how to perform risk assessment as part of the 10-step risk based approach to CSV.
Master Verification and Validation Planning to Meet Tougher U.S. FDA Requirements
John E Lincoln
Product Id: 701506
This V & V planning Webinar/ training will discuss how to companies can re-evaluate their V & V system and related documentation to get to a compliant and new systems and procedures.
Impact of Recent Immigration Developments on Employers
Sameer Khedekar
Product Id: 705344
Recent changes impact not only the employment of foreign nationals, but the broader workforce comprised of green card holders and international travelers. Executive leadership is looking to compliance officers, legal departments and human resources to understand how these changes affect their company. Tune in to learn how to ensure your business is not adversely affected by changes in immigration legislation and policy.
Food Safety and Food Recall Management - Comprehensive Training Package (4 Courses)
Irwin Pronk,Melinda Allen,Dr. Keith Warriner
Product Id: 702296
This comprehensive training package of five courses covers the control of foreign material and pathogens in food manufacturing as well as food recall handling techniques/management.
COMPLIMENTARY WEBINAR - Moving Your IT GRC Program into the New Normal
Michael C Redmond
Product Id: 706556
ISO 27001, ISO 27002, NIST SP800-53 rev.4 Information System Management System (ISMS) are systematic approaches to managing sensitive company information so that it remains secure. It includes people, processes and IT systems by applying a risk management process. In this webinar, You will receive valuable information that you can implement. This is a must in the new world that is facing new Information/Cyber risks every year.
Best Practices to Have A Strong Cyber Security Incident Response
Michael C Redmond
Product Id: 706531
Developing an efficient Incident Response Program that allows an organization to respond with speed and agility is crucial to empowering businesses to maintain continuous operations. Such a solution also reduces revenue loss, reduces fines and lawsuits and protects brand reputation. Information Security, Governance & Risk, are all critical aspects of planning and execution of the Information Security Plan.
CLIA Compliance - From Quality Control to Inspections - Comprehensive Training Package (3 Courses)
Barry Craig
Product Id: 702293
This comprehensive training package of three courses is aimed at helping clinical laboratories ensure compliance with CLIA requirements.
Maintaining a Safe Workplace - Comprehensive OSHA Training Webinar Package (6 Courses)
Christopher J. Miranda,Kenneth S. Weinberg ,James T. Dufour,William Principe
Product Id: 702247
This comprehensive training package of six courses provides enterprises a clear understanding of workplace safety issues such as accident investigation, lockout/tagout, OSHA inspections, OSHA injury and illness recordkeeping, effective safety programs and hazard recognitions techniques.
Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies
Kenneth Christie
Product Id: 703635
This training program will provide attendees with a better understanding of how the FDA conducts their audits and the areas of most focus. In addition, it provides a summary of common GMP deficiencies given to drug manufacturers, to use to evaluate one’s own practices. Finally, when given a regulatory audit finding, this webinar will review the top five items to remember when submitting your responses to them to avoid further questions.
Current Regulatory Requirements for Sterile Products
Kenneth Christie
Product Id: 703672
This webinar will highlight and summarize the 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.
The Regulatory Expectations for Environmental Monitoring Programs
Kenneth Christie
Product Id: 703648
Understand the importance of an effective environmental monitoring (EM) program and its place in your organization. This course will provide insights on regulatory requirements governing EM programs, contamination control practices, and common deficiencies cited by regulatory auditors when auditing EM programs.
Cyber Security : Dealing with Cyber Issues in Your Business Continuity Planning
Michael C Redmond
Product Id: 704820
This webinar training will discuss how to create, test and implement an effective cyber Incident program to counter cyber threat and malware attacks. The Instructor will explain how to measure an organisation’s susceptibility to a cyber attack and will outline critical action areas in such event.
Challenges of an Effective Change Control Program
Kenneth Christie
Product Id: 704638
This training program will provide attendees with a better understanding of current Quality System Regulations (QSR) require companies to maintain qualified equipment, utilities and facilities in a state of control. When changes are made to these items, the change must be documented, explained as to what will be done and the items that may be impacted. This webinar will also highlight what is expected, what to include in procedures and address the challenges faced by industry in trying to establish an effective and manageable program.
Resiliency - Cyber Security, Business Continuity, Disaster Recovery and Emergency Management. You need them all
Michael C Redmond
Product Id: 705983
In this Risk Management webinar attendees will learn the resilience strategies, recovery objectives, cyber/information security, business continuity and crisis management plans and including obtaining management support and organizing and managing the formulation of the function or process either in collaboration with, or as a key component of, an integrated risk management initiative.
Creating a Cyber Incident Response Program That works
Michael C Redmond
Product Id: 705913
This webinar is designed for managers and project leaders who have been tasked with implementing a computer security incident response team (CSIRT). Attendees will learn how to develop a CSIRT Policies, Program, Plan, Playbook, Training and Exercises in their organization.
How to Establish an Effective IT Governance, Risk and Compliance (GRC) Framework - Organization and Responsibilities
Michael C Redmond
Product Id: 704991
This training program will discuss how to develop a great GRC program that ensures proper governance, risk management and compliance management of all IT systems and processes that support the business operations.
NCMR Simplified - A one-form, easy-to-complete, method for simplifying your NCMR Process
Denise Wrestler
90 Min
Product Id: 705876
In this presentation attendees will understand the FDA regulations (21 CFR Subpart I) regarding NCMR, how NCMR should be integrated into your CAPA system, how to best approach NCMR (including initiation, segregation, evaluation, investigation, notification, and disposition), examples of documentation you can use to fulfill the NCMR requirement, as well as tips and tricks to what FDA auditors will look for when they come to visit your site. It will also highlight additional tips and tricks on how to convey the importance of NCMR within your organization and ensure resources are provided to meet process needs.