Managing Compliance during the Pandemic

Recorded Webinar | Danielle DeLucy | From: Jan 15, 2021 - To: Dec 31, 2021

Training Options & Pricing

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Recording
   $229  
DVD
   $249  
Recording + DVD
   $379  
Transcript (Pdf)
   $229  
Recording & Transcript (Pdf)
   $369  
DVD & Transcript (Pdf)
   $379  


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Understand how the COVID-19 pandemic can affect manufacturing operations, employee safety, and how to be flexible and creative in these uncertain times when it comes to business continuity.

Learning Objectives:-

  • Identify how COVID-19 can affect your business
  • Learn how to manage the workforce changes
  • Learn ways to communicate more effectively during the pandemic
  • Streamline employee interaction
  • Identify ways of working more creatively

Webinar Takeaways:-

Background – How did this become a pandemic?

  • COVID-19 virus information
  • Means of infection

Employee Engagement / Interaction

  • Proper communication
  • Effects on business Units
  • Travel Restrictions
  • Communication Changes
  • How to continue maintaining compliance – deviations, CAPAs, document reviews, etc.

Impact on IT systems

  • Video messaging
  • Creative paths to communication

Facilities

  • Traffic protocols for entering/exiting facilities
  • PPE
  • Gown supply continuity

Impact on Workforce

  • Maintain health / mental well-being
  • Manage containment in the workplace
  • Work from home protocols
  • How to manage a limited workforce

Supply Chain / Distribution

  • Assessing product distribution
  • Assessing how to streamline supply chain

Why Should You Attend:-

The pharmaceutical world is mostly staying the course during the unprecedented conditions of the world as we are all living through the COVID-19 pandemic, but that doesn’t mean there aren’t measures that can be taken to make the workplace environment to continue to operate seamlessly and most importantly safely. This course will help attendees understand how the COVID-19 pandemic can affect manufacturing operations. You can ensure employee safety and be flexible and creative despite these uncertain times when it comes to business continuity. Learn how.

Who Will Benefit?

This 60-minute session is intended for professionals in the Medical Device, Biotechnology, Pharmaceutical Industry. Although not presently stated in the draft, the same guide could be used by FDA Regulated Industries personnel

  • Pharmaceutical professionals involved in the manufacture of products
  • All levels of management
  • Human resources
  • Quality professionals

Danielle DeLucy

Danielle DeLucy

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems  assistance in order to meet Regulatory compliance.

Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations.

Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection.

Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.