Best Practices During COVID-19 Webinar Feb. 9, 2021


WCG FDAnews

WCG FDAnews

Maintaining Your Risk-Based Cleaning and Disinfectant Programs:

Best Practices During COVID-19

An FDAnews Webinar

Tuesday, Feb. 9, 2021, 1:30 p.m.-3:00 p.m. EST

https://www.fdanews.com/riskbasedcleaning

The task of maintaining a controlled cleanroom is never simple and COVID-19 has made it more challenging. From COVID-19 monitoring to contact tracing and social distancing, cleanliness and sterilization remain essential during the pandemic.

This webinar will discuss the newest technologies to keep a cleanroom in a state of control. We’ll also tackle the regulatory expectations around this requirement, including those of the FDA and international regulatory agencies.

Cleaning and disinfecting expert Jim Polarine will share tips on how to best design a risk-based program during this global health crisis. He will discuss industry trends, global regulatory expectations and how to maintain a controlled cleanroom. From his experienced perspective, attendees will learn what one needs to know to both meet written guidance and create the most sterile cleanroom feasible.

During this webinar, we will cover:

● Regulatory Expectations

         a. Requirements of FDA, Medicines and Healthcare Products Regulatory

             Agency (MHRA), Agência Nacional de Vigilância Sanitária (ANVISA),

             National Administration of Drugs, Foods and Medical Devices (ANMAT),

             Health Products Regulatory Authority (HPRA), European Medicines

             Agency (EMA) and Agence Nationale de Sécurité du Médicament et

             des Produits de Santé (ANSM) inspectors as they relate to COVID-19

         b. Lessons learned from FDA warning letters and 483s

● Guidance Documents

         a. Details in USP 43 (1072), PDA Technical Report #70 and other industry

             documents

         b. New guidance in Draft Annex I

● Basis Cleaning and Disinfection Frequencies

         a. Keeping cleanrooms controlled to ensure safe, pure and efficacious products

● Industry Best Practices

         a. Disinfecting during the COVID-19 pandemic

         b. Managing fungal and bacterial spore excursions

● The Latest Advances in Application Equipment and Cleaning Methods

         a. Disinfectant rotation, sterility, application and rinsing

         b. COVID-19 monitoring, contact tracing and social distancing

             requirements

Maintaining a cleanroom has become more difficult due COVID-19 but not impossible. With expert guidance, one can manage cleaning, disinfecting and sterilizing with best practices and a risk-based program.

Interested in registering multiple sites?

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally

to learn about our special multisite discount.

Webinar Details:

Maintaining Your Risk-Based Cleaning and Disinfectant Programs:

Best Practices During COVID-19

An FDAnews Webinar

Tuesday, Feb. 9, 2021, 1:30 p.m.-3:00 p.m. EST

https://www.fdanews.com/riskbasedcleaning

Tuition:

$287 per site

Easy Ways to Register:

Online: https://www.fdanews.com/riskbasedcleaning

By phone: 888.838.5578 or 703.538.7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations

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