Webinars >>FDA Regulations                                                                                                          Australia - Sydney Time
Five Best Practices for Using Email in FDA Regulated Industry

Emails are the most frequent mode of communication due to their ease of use, convenience of access, and automatic tracking. However, email records are also the most common area of concern during audits by FDA. Almost all the communication during a product development, marketing, pharmacovigilance, and practically all aspects of the regulated industry depends on emails between team members, management, legal, and financial compliance professionals. Emails act as the key evidence to demonstrate timely reporting, decisions, project management activities, and regulatory activities. Proper security measures, archiving, organizing and storage of emails are critical competencies expected of all FDA regulated companies. Most companies lack comprehensive policies on email use and lax enforcement of rules. In addition, company often lack training in email etiquettes, best practices for formal and informal communication, remote access of emails, and security measures for using public and private broadband outside corporate offices.   
Why should you attend:
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This webinar, presenting by a leading quality assurance industry expert will discuss FDA expectations from email policy, and best practices for avoiding errors and accidents. The session will highlight key regulatory requirements, dos and don’ts, common areas of concern, and trouble-shooting practices for FDA regulated industry using case studies and examples from the presenter’s vast experience helping companies big and small in dealing with email-related issues. The webinar will provide precise and complete list of measures and checklists to be implemented by FDA-regulated companies to bullet-proof their email systems. The training is designed to provide a well-rounded training to all stakeholders in all aspects of the FDA rules and practical tips for complying.
Areas Covered in the Session:
  • Regulation and Requirements for email records
  • Use of desktop, laptop, mobile phone and other platforms for emails
  • Validation of email software
  • Critique of different email systems with pros and cons
  • Suggested policies for use of home network, public wifi and phone broadband for email access
  • Best practices for email management: organization, archiving, storage, and access
  • Common audit findings
  • Electronic and paper records for email communications
Who will benefit:

The following individuals or disciplines will benefit from attending this Webinar:
  • Regulatory affairs personnel
  • Quality assurance personnel
  • Information technology personnel
  • Vice presidents, Directors and Managers
  • People interested in investing in the FDA-regulated industry
Date: December 8, 2016
Time: 1 PM AEST        
​Duration: 60 Minutes

Speaker
Mukesh Kumar, PhD, RAC, VP (Regulatory Affairs and Quality Assurance), Amarex Clinical Research, USA
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    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com