Five Best Practices for Using Email in FDA Regulated Industry

Date: February 5, 2025
Duration: 60 Minutes
Time: 12 PM EST

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:
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

Speaker: Mukesh Kumar

PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Webinar Fee

Single Registration

$199

Group Registration (5 Persons)

$699

Group Registration (10 Persons)

$1199

Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.

Terms & Conditions to register for the Webinar

Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com

Payment

We accept credit card, debit card, and PayPal.

Cancellations & Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.

Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.

In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.