Performing an Effective, Robust and Compliant Sterility Failure Investigation_ How to Avoid Common Mistakes _ eMedEvents

1. 27/10/2021, 10:30 Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes | eMedEvents  Introductory Offer Sign In Assistant Are you an Organizer?   Maximize CME/CE Allowance SEARCH  ‹ › Internal Medicine/Family MedicineOncologyRadiologyPsychiatryPediatricsEmergency MedicineNeurologyCardiologyDermatologyDentists Obstetrics and Gynecology Home / Dentist / Online CME / Webcasts / Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes  Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes   By ComplianceOnline  Webcasts90 MinutesUSD 299.00 REGISTER  Overview Conference Summary Price Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes is organized by ComplianceOnline. Specialties Who Will Bene?t: This webinar will provide a great resource to personnel involved within the following departments in the pharmaceutical, biotechnology, diagnostics, drugs, cell therapy, biologics, raw material, excipients, chemicals and API suppliers, and medical device industries: Target Audience Contact Us • Quality Control • Sterility Assurance • Manufacturing/Production • Senior Management • Raw Materials Tester • Supplier Quality • Regulatory Affairs • Quality Assurance • Compliance • Design Engineers • Facility, Maintenance and Engineering • Contract Manufacturing Organizations (CMO) • Active Pharmaceutical Ingredients Suppliers • Chemical Suppliers • Excipient Suppliers Description: This training program will highlight mistakes often made when corrective and preventative actions are not clearly identi?ed and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to ?nished products, bulk drug substance, raw materials or excipients. Why Should You Attend: This training session will provide an understanding of the regulations guiding the sterility testing program and the process of conducting an effective, robust and compliant sterility test investigation for various types of sterile products. Attendees will gain an understanding of: • The step by step investigational tool to apply when conducting sterility test failure investigation. • How to delineate between a probable and an af?rmative root cause using the recovered contaminant based on the investigational ?ndings. • Possible corrective and preventative actions and how to apply the results of the investigation (investigational ? di ) h f db h f d i hi h l https://www.emedevents.com/online-cme-courses/webcasts/performing-an-effective-robust-and-compliant-sterility-failure-investigation-how-to-avoid-common-mistakes 1/3

2. 27/10/2021, 10:30 Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes | eMedEvents ?ndings) to other manufactured batches of products within the same cleanroom. • Disposition of the manufactured batch of product with a failed sterility test result, regulatory guidelines associated with a retest of the affected batch and handling a sterility failure associated with a commercially distributed product under stability testing program. The content of a sterility test investigation form to provide robustness to an investigational process will be shared with the attendees as a tool that may be used when designing a sterility failure investigation program. Learning Objectives: • Discuss the regulations guiding manufactured product sterility testing such as USP <71> Sterility Testing and how to ensure adherence to program testing requirements. • Step by step process in conducting sterility test failure investigation and what to look for during the entire investigation process. • Discuss the role of contaminant as a key tool during investigational process such as microbial identi?cation of contaminant and if it is important or not important - why or why not? • Performing a product retest during a sterility failure investigation and how to apply corrective and preventative action based on the ?ndings of a sterility failure investigation. • How to disposition impacted products based on investigational ?ndings while avoiding common mistakes during product disposition. • Impact of sterility failure investigation for commercially distributed products under a stability testing program. Price Registration Name Category Last Date Price Recorded Link Only Fee Final Fee USD 299.00 Recorded USB Only Fee Final Fee USD 399.00 Specialties Pharmacy and Medicine Target Audience Pharmaceuticals Contact Us Toll free Number 1(800) 828-2059 Email support@eMedEvents.com Chat Assistant Live Chat Reviews Given by People No Reviews available. Be the ?rst to write a review. Add Review Recommended Conferences Pharmacy and Medicine Webcasts USD 299   Combination Drug/Device Products CGMPs - Final Rule Pharmacy and Medicine https://www.emedevents.com/online-cme-courses/webcasts/performing-an-effective-robust-and-compliant-sterility-failure-investigation-how-to-avoid-common-mistakes 2/3

3. 27/10/2021, 10:30 Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes | eMedEvents Subscribe for Newsletter, Medical News & Blog Updates Subscribe Your Email Address No spam, ever. Your email address will only ever be used for newsletter, medical news & blog updates Conference Organizer Services Marketing & Advertising Speakers Pharma Companies & Medical Device Manufacturers Marketplace Custom Pro?le List your Event for Free Event Marketing & Advertisement Event Listing Promote your Pro?le Advertisement Promote your Event Virtual Event Creation Publish your Work Email Campaign Targeted Marketing Talk to our Marketing Expert Online Event Hosting Network with Peers & Organizers Banner Advertising Data Mining Registration Widget Push Noti?cations Learning Management System (LMS) Search Engine Optimization (SEO) Payment Gateway Social Media Marketing (SMM) Accreditation Web Development Healthcare Professionals (Physicians, Nurses, Dentists..) Medical Resources Travel Deals Find CME/CE Events Online Courses CME Conferences 2021 CME Requirements by Country/ State Stays Free CME/CE Events Webinars CME Conferences 2022 Flights Initial Licensure Requirements Featured Events Webcasts CME Conferences 2023 Cars Medical Assessment Boards Popular Events Journal Based CME CME Conferences 2024 Specialty Certi?cation Boards In-Person Events Podcasts Events by Specialty - Online, In-Person, Hybrid Medical Societies by State Hybrid Events   Events by Location - City, State, Venue Medical Societies by Specialty Cruise Events Non CME Events Medical News Board Review Courses Company         Follow Us Download Our App About Us Blogs Privacy Policy Success Stories Pressroom Cookies Policy       Contact Us Terms & Conditions Copyrights © 2021 eMedEvents Corporation, All Rights Reserved. https://www.emedevents.com/online-cme-courses/webcasts/performing-an-effective-robust-and-compliant-sterility-failure-investigation-how-to-avoid-common-mistakes 3/3