Quality Risk Management: Ensuring Shared Responsibility across Key Stakeholders

Sustainable quality risk management depends not only on consistent processes and protocols, but more importantly on the commitment of all key stakeholders. Invited Keynote speakers from EMA, TGA, and FDA-Philippines will share their insights on the positive impact and best practices for collaboration and shared responsibility between regulatory agencies and industry.

APAC PHARMACEUTICAL MANUFACTURING CONFERENCE Opening Plenary Session | Quality Risk Management: Beyond Theory to Practical Implementation
Many international regulatory authorities have published guidance/draft guidance on Quality Risk Management, as well as ICH and WHO. This fact highlights the importance of QRM in manufacturing and quality operations: it helps coordinate and direct an organization's activities to meet customer and regulatory requirements; it helps in day-to-day decision making within the quality and manufacturing units; it helps ensure the effectiveness of CAPAs; and it helps organizations improve effectiveness and efficiency on a continuous basis. However, despite the clear benefits and need for QRM, organizations often struggle with implementing one fully. In this session, we will discuss the practical implementation of a QRM and how to integrate and avail the organization to the resulting benefits in daily operations and sustainable supply.

Adapting During the Pandemic: Changing Regulatory Processes | The COVID-19 pandemic forced unanticipated change in the way inspections, reviews and EUAs are handled by regulatory agencies and the industry. The impact on supply chain transfers, locations, registrations, and visibility is being felt across the industry.  This session will focus on the regulatory guidance and direction provided by global agencies for adapting to and managing remote processes and unprecedented supply chain needs.

Creating Comprehensive Responses To Regulatory Actions | With an increasing number of non-conformances, warning letters/OAIs for sites governed by US regulations, one has to ask what the missing link might be. Companies responding to regulatory actions need to create comprehensive responses that not only address their remediation plan, but also identify how they intend to ensure the sustainability of the remediated processes. Surely, most companies participating this conference must have been through at least one USFDA physical audit. We are all fully aware that our expertise, presentation, knowledge, and behavior are important traits while facing agency investigators during inspection time. What is more important is our post-inspection behavior. How we read and understand a 483, how we respond, and how we communicate with the agency all play a vital role in how we will draw the closure lines. They can be good short ones or a very long one.  Response to a 483 observation is perhaps the last and best opportunity to tell your side of the story before many agency officials (compliance, enforcement, OMQ, OPQ, to name a few) who have not been to your facility and are unaware of what might have happened during the inspection. Form 483 is the living, guiding document for them to assess your facility and make some assumptions of what happened during inspection. You may be surprised to learn that FDA believes it is your responsibility to work with its investigators before they leave your facility to address any inaccuracies on the Form 483.  Fortunately, during these unprecedented times, the FDA has implemented an interim COVID-19 process for communicating with facilities following FDA review of records that will help companies to navigate the post-OAI requirements. Join us as we discuss how to create comprehensive responses to regulatory actions  with industry peers, SMEs, and global regulators (USFDA, MHRA).

CMO/CDMO Relationships, Management, and Quality | As more organizations rely on CMO/CDMOs to meet supply demands, managing multiple sponsor requirements becomes challenging. As a sponsor, ensuring your requirements are met are critical. The track will specifically focus on the process of application and revision of such following significant compliance findings (eg Data Integrity) at the CMO/CDMO. What are some of the expectations if the applicant decides to withdraw the facilities (CMO) specifically under compliance action for the pending applications? What new data would be needed to support the application with the addition of a new site? We will discuss the challenges of a sponsor working with multiple CMOs during a pandemic and provide strategies to ensure adequate controls, oversight and consistency.

Regulatory and Industry Panel | Maintaining Full Transparency with Regulatory Agencies