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Many international regulatory authorities have published guidance/draft guidance on Quality Risk Management, as well as ICH and WHO.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.

CASE STUDY 4: Aseptic Processing Controls | Imagine the perfect storm. This case study involves a manufacturer of medically necessary sterile drug products and combines numerous failures across various systems. Dive deep into deficiencies associated with media fills, sterility testing, environmental monitoring, aseptic line design, and data integrity and governance.

CASE STUDY 3: Critical Review of Quality and Manufacturing Data | Emer-Pen is part of General-Pharma’s auto-injector portfolio. It is a single-use drug-device combination product, comprising device components with sterile injectable solution cartridge. Emer-Pen is used in life-threatening emergencies prior to gaining access to qualified medical care. Approximately 4 million packs (2 devices per pack) were prescribed in the local market during financial year 2015-16.

CASE STUDY 2: Cross Contamination Controls | A lab assay discovers viral residue in a product that was recently released. This plan will include an emergency response describing market action, remediation and plans to effectively communicate with regulatory authorities and customers.

CASE STUDY 1: Practical Applications for OOS Investigations/Assessments | Background to case-studies that will be addressed: Issues observed included observations of repeat testing until a better and/or passing result is obtained; maximum number of retests NOT specified in SOP; vary based on variability of method and is adjusted during OOS Investigation; multiple attempts of retesting and different definition of “retesting”; disregarding OOS results and failure to thoroughly review unexplained discrepancies; product quality failures are ignored without scientific justification. Testing into Compliance: averaging of failed replicates; finding a flaw in the analysis after the run (e.g., Analyst failure/error/ SST/ QA oversight/ Decision making in QC); failure to extend investigation to other batches.

Case Study Report-Outs and Discussion |

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).