Viral safety controls and testing are required by regulatory agencies for biologic drug substances and products produced from mammalian cell lines, tissues or plasma, based on the risk to human patient safety.
This workshop will focus on regulatory guidance from the US Food and Drug Administration and the European Medicines Agency and trends for adventitious viral safety risk mitigation. These include control of raw materials, validation of viral inactivation/clearance during manufacturing, along with in-process and specification testing.
Our expert presenters will discuss comparisons of Chemistry, Manufacturing and Control electronic Common Technical Document submission approaches for recombinant protein/monoclonal antibody and other viral vector/vaccine based therapeutics. They will present case studies for challenging plasma-derived and transgenic animal-derived drug products with specific examples of submitted marketing application information. They will also teach attendees proper use of safety margin calculation formulas based on regulatory requirements of adventitious agent log reduction value over the entire manufacturing process using templated scenarios.
Registration Fees & Deadlines
Present – 3 November 2024: Member $495 | Nonmember $580
4 November 2024 - December 4, 2024: Member $580 | Nonmember $680
Learning Objectives
- Learn how to develop a viral safety risk mitigation strategy for biologic drug products.
- Learn how to implement raw material evaluation, manufacturing process clearance/inactivation, and testing to meet the regulatory requirements for viral safety.
- Learn how to submit appropriate and sufficient information on Adventitious Agent Safety Evaluation in module 3.2.A.2 for biologic drug substance and product.
Who Should Attend?
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Speakers
Ushma Mehta
Regulatory Consultant, Milliporesigma
Janmeet Anant, PhD, PMP, RAC, serves as a senior regulatory consultant at MilliporeSigma, focused on pharmaceutical manufacturing, specifically working on sterile injectables. Janmeet has been a key member of the Paradigm Change in Manufacturing Operations, which is a quality risk management team of the Parenteral Drug Association. In addition, Janmeet serves as an executive board member for the Bioprocess Systems Alliance, vice-chair of a subcommittee of the American Society of Mechanical Engineers - Bioprocessing Equipment standard setting organization, and a member of the regulatory governance team at BioPhorum. With over 20 years of experience in the pharmaceutical industry, Janmeet has been consulting on complex regulatory strategy projects with pharmaceutical drug manufacturers, leveraging skills from his Project Management Professional and Regulatory Affairs Certification credentials. Janmeet has a Bachelor of Science degree in Chemistry and a PhD in Pharmacology.
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
RAPS@raps.org