Currently, there is no harmonized approach to technical and regulatory lifecycle management considerations. While the International Council on Harmonisation’s (ICH) Q8, Q9, Q10 and Q11 guidance documents provide opportunities for a more science- and risk-based lifecycle approach, several gaps exist that limit full realization of intended benefits. The lack of a harmonized approach to technical and regulatory lifecycle management aspects hinders innovation and continual improvement in the pharmaceutical and biotechnology sectors.
This webcast reviews ICH Q9, 10 years following its inception and the impact of the EU Annex 15 update and concludes with a review of the current status of ICH Q12.
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.
Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building
, and group projects. A high level of participation is expected from each attendee.
Upon the webcast's conclusion, you will learn:
- Implementation path Annex 15
- Current issues with ICH Q9 implementation and how these can be improved
- The scope of ICH Q12
Who should attend
- Quality managers
- Commissioning and qualification (C&Q) managers
- Validation engineers
- Compliance resources
Alice Redmond, vice president for CAI Europe and Biopharma and Medical Devices
Alice Redmond is a senior consultant with more than 26 years’ extensive experience in regulatory compliance, commissioning, qualification and validation. She has developed regulatory compliance and C&Q strategy and executed it for a broad range of projects including fill finish, biotech, gene therapy, medical devices, small and large molecule active pharmaceutical ingredients and oral solid dosage facilities. She is a member of the Parenteral Drug Association and International Society for Pharmaceutical Engineering. Redmond has presented at local and global events and numerous regulatory agencies in the areas of quality metrics, pharmaceutical quality systems and quality risk management.
Questions? Call the RAPS Solutions Center at +1 301 770 2920, ext. 200, or email firstname.lastname@example.org.