Location: Webinar

Jim Polarine is teaming up with FDA News to bring a unique and comprehensive webinar. This webinar will focus on the latest technologies for keeping your cleanroom sterile and clean along with best practices.  Jim will also cover global regulatory expectations, industry trends and how to maintain a controlled cleanroom. 

Webinar Agenda & Topics:

  • Regulatory Expectations
    • Requirements of FDA, MHRA, ANVISA, ANMAT, HPRA, EMA and ANSM inspectors as they relate to COVID-19
    • Lessons learned from FDA warning letters and 483s
  • Guidance Documents
    • Details in USP 43 <1072>, PDA Technical Report #70, and other industry documents
    • New guidance in Draft Annex 1
  • Basis Cleaning and Disinfection Frequencies
    • Keeping cleanrooms controlled to ensure safe, pure and efficacious products
  • Industry Best Practices
    • Disinfecting during the COVID-19 pandemic
    • Managing fungal and bacterial spore excursions 
  • The Latest Advances in Application Equipment and Cleaning Methods
    • Disinfectant rotation, sterility, application and rinsing
    • COVID-19 monitoring, contact tracing and social distancing requirements

Who Should Attend? 

  • Pharmaceutical, Biotech and Medical Device Staff
  • Hospital Compounding Pharmacy Staff
  • Oral Solid Dose Team Members
  • Validation Managers
  • Quality Control Managers
  • Lean Managers
  • Operations Managers
  • Cleanroom Managers
  • Regulatory Affairs Managers
  • Production Managers
  • Quality Systems Managers

Attendees will learn how to manage cleaning, disinfecting, sterilizing and how to adapt during this global pandemic through best practices and a risk-based program.  

Click Here to Register