How to Manage Impact of Coronavirus (COVID-19) for Global Pharma and Biotech Continuity
Danielle DeLucy, MS, is the 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 19 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.
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, employee safety and how to be flexible and creative in these uncertain times when it comes to business continuity.
- Background – How did this become a pandemic?
o COVID-19 virus information
o Means of infection
- Employee Engagement / Interaction
o Proper communication
o Effects on business Units
o Travel Restrictions
o Communication Changes
o How to continue maintaining compliance – deviations, CAPAs, document reviews, etc.
- Impact on IT systems
o Video messaging
o Creative paths to communication
o Traffic protocols for entering/exiting facilities
o Gown supply continuity
- Impact on Workforce
o Maintain health / mental well-being
o Manage containment in the workplace
o Work from home protocols
o How to manage a limited workforce
- Supply Chain / Distribution
o Assessing product distribution
o Assessing how to streamline supply chain
- 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
Course Level - Intermediate
Who Should Attend
- Pharmaceutical professionals involved in the manufacture of products
- All levels of management
- Human resources
- Quality professionals