The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: December 2, 2021 at 10am to December 3, 2021 at 4pm
Street: Compliance Online
City/Town: Palo Alto
Website or Map: https://www.complianceonline.…
Event Type: seminae
Organized By: ComplianceOnline
Latest Activity: Oct 30, 2021
The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including Active Pharmaceutical Ingredients (APIs). These guidances align Process Validation activities with a product lifecycle concept and with existing FDA and EU guidances, including the FDA/International Conference on Harmonization (ICH), Guidance for Industry, Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. The lifecycle concept, new to these Guidances, link product and process development, qualification of the commercial manufacturing process, and maintenance of the process in a state of control during routine commercial production. These guidances also support process improvement and innovation through sound science and risk management. The new Process Validation Guideline/Practice incorporate elements of Process Validation as early as the Research and Development phase, and continues onward through Technology Transfer, into the Phase 1 IND Clinical Trial manufacturing phase, and ultimately into Phase 2 and 3, and then commercial manufacturing.
Each facility, whether producing small or large molecules requires both an overall Site Validation Plan as well as specific validation plans to manage the multiplicity of validations required to confirm the successful manufacture of each of its products.
These questions will be addressed within Stage 2 as presented here and include utilization of Process Validation and Phase 1, 2 and 3, where their Guidances blend and where they remain distinct. In particular, Stage 3.
Important: Please plan to bring a multidisciplinary group from your Company to gain the most from this very important seminar.
Why these FDA Guidance/EU Guidelines for Industry - Process Validation is so important to the pharmaceutical and biotechnology industry.
Those who will benefit from this ON-LINE seminar include