LIVE Webinar: October 19th 2018, 1 PM EST – $99 – Limited Seats Available
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(purchase includes recording viewable for 1 year)
One of the top observations by the FDA within 503As (including HOSPITALS), 503Bs AND manufacturers is:
Procedures for sterile drug products – 62 cited (21 CFR 211.113(b)):
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed]. Specifically, ***
What this boils down to many times is having a “lack of control” over your controlled environment. For those of you in hospitals and compounding pharmacies, if you’ve ever had issues with failing a cleanroom certification; same thing, this is an example of not having control over your cleanroom.
While there’s many factors that can affect your controlled space, there are some very important things that you can do TODAY to gain and maintain control over your cleanroom. I’m very excited to announce that I’m offering a webinar on this topic geared specifically toward pharmaceutical compounding. I’m very fortunate to have made some excellent contacts over the last couple of years; one of those contacts is Melissa Stefko.
Melissa Stefko is an experienced Pharmaceutical and Biotechnology professional with a background in Quality Assurance and Quality Control in aseptic sterile processing. Prior to joining Wells Pharmacy Network, Ms. Stefko served as Head of Quality with a start-up 503B Outsourcing Pharmacy and gained a strong CGMP understanding through previous positions within pharmaceutical manufacturers. Ms. Stefko is an active member of the American Society for Quality as a Certified Quality Auditor and is a member of Institute of Environmental Sciences and Technology, American Society for Microbiology, Parenteral Drug Association, and IACP. Ms. Stefko holds a Masters in Business Administration, a Masters of Science in Biotechnology, and Regulatory Affairs Certificate.
At Wells’ Tampa location she has been instrumental in assuring quality for their sterile operations. It’s a great reflection on her that when the FDA inspected her location they had 1 observation and are in the process of closing that out. Melissa also has an active schedule presenting at pharmaceutical industry conferences on quality assurance and quality control topics, including contamination control.
Since I started PharmacyInspection.com I’ve tried to offer pragmatic solutions for improving your aseptic operation. My goal with each post is for someone to be able to take something away that they can implement TODAY. This webinar is no exception.
Check out the webinar October 19th 2018 at 1 pm. If you’re unable to make the live event you can purchase and the recording which will be available for 30 days post-webinar.
Contamination of pharmaceutical products can cause catastrophic consequences in the pharmaceutical industry; from patient safety and patient access to drug shortages through business viability and sustainability. In the manufacturing of sterile pharmaceutical products, contamination prevention is a critical component for complying with state and federal regulations as well as protecting the safety of the public. In the wake of the meningitis outbreak of 2012, FDA and other regulatory agencies have heightened their approach and expectations on monitoring products for contamination. Although bioburden levels may be able to be controlled with suitable cleaning methods, preventing the occurrence is the best approach when assessing the risk of contamination for a facility and/or drug product.
Cleanroom suites play a critical role in creation of sterile pharmaceutical drug products. Although many methods of decontamination and sterilization have proven successful, prevention of the contamination is key to maintaining optimal microbial levels in an aseptic environment. This talk will discuss the top potential sources of contamination and how to effectively prevent them from contaminating product, the cleanroom suites and the significant impact an outbreak may have on the organization as a whole. Additionally, this talk with also evaluate the top potential sources of contamination in detail based on risk and the specific role they play in the pathway to contamination. Discussion topics include facility design, cleanroom behavior, gowning and cleaning requirements, etc.
Join our interactive online training course where you will learn:
- Review of NECC outbreak and LIST the root cause associated with the contamination
- Discuss prevention of contamination of sterile drug product and facility
- Examine principles of Containment of contamination, if it exists
- Explain steps for remediation of contamination
- Discuss principles of Quality by Design (QbD) Facility to avoid contamination potential pitfalls
WHO SHOULD ATTEND
This course is designed for management, pharmacists and technicians involved in clean room operations who will benefit from a better understanding of how a quality contamination control program impacts clean room operations. The course focuses on facility design, cleanroom behavior, gowning and cleaning requirements, etc.
HOW TO PARTICIPATE
This webinar will be offered live. With your course purchase, you may participate live or view the recording at your convenience (available for 30 days). Access instructions for the live viewing will be emailed to you 3 business days prior to the scheduled date. Access to the recorded version will be available 1 business day after the live course has run.
To access the course, you need only a telephone and computer with internet access.
This webinar is scheduled for live instruction on
Date: October 19, 2018
Time: 1:00 – 2:o0 PM EST
Choose to participate live or listen to the recording afterward (available for 30 days post-webinar)!
THE TRAINING PLATFORM
Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.