Dr. Michael J. Miller
This webinar will explore the implementation of rapid microbiological methods (RMM) within the pharmaceutical, biopharmaceutical and advanced therapy medicinal product (ATMP) industries.
Number of pharma companies have been cited by regulatory bodies for inadequate control on contamination with traces of Penicillins or Cephalosporins (β-lactums). This session will deal with Regulatory Expectations For Penicillin Containment.
Preventing Contamination and Cross Contamination in the manufacture of highly active or highly hazardous substances in the aseptic Processing will be the topic of the Webinar.
This webinar will provide an insight into the thinking behind the ISPE GAMP Good Practice Guide ‘Data Integrity – Manufacturing Records’. Presented by Karen Ashworth, who led the team that developed the process control systems input to the guide, the presentation will explain: What types of data are typically collected by manufacturing systems How to decide which of these are GxP critical How to mitigate risks.
Khaled Moussally, Stephen Cook,Harsha Chulki, Sachin Bhandari:
In this webinar hear directly from the “FDA/industry CSA Team member”, featuring industry experts, who will conduct a panel discussion, about the upcoming draft Computer Software Assurance (CSA) draft guidance from FDA’s CDRH division. The guidance covers the principles of risk-based CSA, provide FDA’s perspective, and share numerous real-life success stories and their resulting value.
.The webinar will focus on the pharmaceutical residues, Science behind cleaning, variables impacting cleaning, common cleaning issues and troubleshooting along with case studies.
This Webinar will cover Key principles and practices for sterilizing filter selection and best usage in parenteral manufacturing
•Considerations for Selecting right Sterilizing Filter
•How do you qualify your filters once selected
•Design Space for Sterilizing Filter
•What are different configuration & when to use what
•Examples of System Design & Compliance to Regulations
This Webinar will give you answers to the following questions:
What are the conceptual differences deciphered from the guidance and even more...?
Where do we put more focus: QbD, PPQ or CPV? & Why?
Where do my legacy products fit in?
Are the regulators really trying to tell us something?
What is my organization's PV maturity level? Attend and get a solid measurement checklist.
For over a decade India has been a key link in the global supply chain of Pharmaceuticals, supplying not just API’s, but complete dosage forms. As manufacturing becomes more sophisticated and closer to the end user, the patient, regulatory expectations increase. In this class we will discuss how FDA expectations for environmental control compare with EMA – PIC/S, WHO and others.
Prem Iyangar , Neeta Iyengar
This webinar deals with New age technologies and it's adoption in pharmaceutical Manufacturing
This webinar delineates the need for creative ideas for the design and operation of water systems during monsoon season.
FDA-regulated firms face an enormous challenge keeping up with agency priorities and expectations—especially companies that produce older products within an ever-changing regulatory landscape. you will learn why it is important to assess legacy products for potential GMP compliance gaps, how to assess your legacy products, and where the most likely compliance pitfalls are.
This training will address the common errors and misunderstanding related to smoke studies, specifically addressing updated regulator thinking.
This Webinar deals with challenges in Designing & Qualification of Purified water Systems to meet regulatory requirements.
In this webinar you will get to hear about • Most Frequent US FDA Observations 2019 • Points to consider when responding to observations • Understanding the real reasons behind the observations • Case studies related to inadequate responses • Corrective & Preventative Actions (CAPA)-Common mistakes • Paper based risk management versus science based risk prevention • Why risk assessments fail