34th SQA Annual Meeting and Quality College

E-1  QA for Today and Tomorrow - Challenging the Status Quo to Create the Future of QA

Abstract:
QA Professionals have the ability to impact quality in many different ways. Our role in interpreting, developing and applying standards and best practices is forever evolving.  This  interactive session will provide an opportunity for all QA Professionals, regardless of how long they have been in QA, to discuss ways to re-define the ”QA Experience” of the future. QA Professionals will need to adapt to changing communication methods and styles to meet the needs of their customers, whether internal or external stakeholders. We will spend the first part of the session discussing current thinking and challenge the status quo of ‘We have always done it that way so that is that is how we will do it now’.   The second part of the session will include 2 panels – one will be a panel of representatives with many years of varying QA experience and the other will be a panel of newcomers to industry. These panels will provide their perspective on issues currently facing the QA Professional, expected future challenges, and engagement of new people into this profession. We will discuss ways to incorporate existing and new ideas on how to address these areas.  QA will always be a profession where we are rewarded for our expertise – let’s help each other figure out to how continue that today and tomorrow.  

Category:
Beyond Compliance

Level of Content:
Basic

J-1   Medical Device Test Article Characterization - Sponsor and CRO Perspective 

Abstract:
Medical devices run the gamut from single materials to composite materials, may include different functional components, be combination products, electronic devices, and may have associated software.  With all this variation, how do you meet the requirements of §58.105, clearly identify what is being tested and have sufficient documentation to prove it.  This session will present best practices to achieve compliance for test article characterization for the various types of medical devices that are currently available.  Best practices will be discussed from the perspective of the CRO and sponsor.

Category:
Medical Device

Level of Content:
Advanced

O-1   Supporting the Medical Device Single Audit Program (MDSAP): The Role of the CRO

Abstract:
A global approach to auditing and monitoring the manufacturing of medical devices has been developed from an international coalition between the United States, Australia, Brazil, Canada and Japan. This international consortium, Medical Device Single Audit Program (MDSAP) became fully operational in 2017. Starting the 1st of January 2019, MDSAP will be the only certification accepted by Health Canada. The Canadian MDSAP transition period corresponds closely with the transition period for the revision of ISO 13485. With MDSAPS full implementation on the horizon, time is flying by.
MDSAP allows medical device manufacturers the opportunity to achieve and maintain regulatory compliance, including the consortium countries, with a single audit certification. The MDSAP audit report has bene accepted as a substitute for routine Agency inspections. The audit, based on ISO 13485 and 14155, requires a preparation period to ensure compliance to the MDSAP guidance.
Due to the nature of our CRO business, we have diverse clientele and offer practical and customized services with an expertise in medical device clinical research. As international regulations evolve, our team is undergoing a global effort to establish best practices to accommodate and preemptively maintain compliance.  Key factors to consider for proactive implementation:
·        Contracts designed in compliance with the guide prior to certification
·        3rd Party Auditing Organizations scheduling, expect delays and forced prioritization
·        Effects of BREXIT, have a contingency plan
·        EU MDR/IVDR timeline early 2020, extends the QMS adaption timelines
·        Re-designation of Notified Bodies, anticipate more demand of and from Notified Bodies
·        Post-audit time frames, e.g., nonconformities etc.

Category:
Medical Device

Level of Content:
Intermediate 

T-1   Archiving Electronic Data – Black and White and Shades of Gray

​​​​Abstract:
Rapidly advancing technology seeking breakthroughs for treating diseases with medical devices, drugs, and combination products, requires access to  and increasing use of computerized systems in GLP studies. Data types run the gamut from proprietary software used for physiological monitoring,  advanced imaging systems data, clinical pathology data,  digital images (photographs and micrographs), and systems to collect comprehensive preclincal data sets just to name a few. The array of electronic data coupled with different system owners, server access limitations, varied data collection procedures, storage capacity, stability of media, and ability to read the data for the period required for retention are some of the challenges faced as electronic data becomes the norm. The Medical Device Specialty Section, Computer Validation Initiative Committee, and Scientific Archiving Specialty Section will discuss the issues and recommend best practices for archiving electronic data in compliance with 21 CFR Part 58 and Part 11.

Category:
Scientific Archiving

Level of Content:
Intermediate

Y-1  Remote or Multisite Vendor Auditing - Perspectives from a Sponsor and a CRO 

Abstract:
Summary – With subcontracting being the new normal and companies looking at overall efficiencies and cost savings, is there a way to oversee your Vendors without traveling all across the world?
Remote and Multi-site vendor auditing may be the solution for you, but when is it most appropriate to undertake these types of audits.  As a Sponsor, how does one go about conducting an effective remote or multi-site audit?  As a Vendor, how does one accommodate these audits?  What are the benefits, challenges and deficiencies with these types of audits.
This presentation will give answers to these questions from both the Sponsor and CRO perspective.

Category:
Beyond Compliance

Level of Content:
Intermediate 

DD-1  Next Generation Quality Management Systems 

Abstract:
With the adoption of the ICH GCP E6 R2 requirements and the latest industry guidance, it is important for sponsor companies and Clinical Research Organizations (CROs) to re-evaluate and implement an enhanced Quality Management System (QMS).  This session will provide information on recent changes to industry requirements, outline the components of a modern QMS, provide examples on how to apply the QMS at all levels of your organization and take a look at some upcoming industry trends. Session participants will be able to take this knowledge back in to their organizations, improve their QMS and better prepare for the future.
Each presentation will include real life examples and discuss collaboration between the Quality organization and key stakeholders. Topics covered in the session include:
-An effective QMS framework that encompasses regulatory requirements, industry guidance, and sponsor requirements
-A focused review of some key QMS elements – Quality Policy, Quality Manual, Risk Management, Business Continuity, Quality Oversight and Controlled Documents
-Overview and examples of how to put a robust QMS in practice at the partnership, program, and project level for effective quality oversight and first time quality performance of clinical trials
-A look to the future – eQMS, wearables, eInformed Consent, Real World Data

Attendees will gain knowledge about current QMS requirements, the QMS in practice and what to plan for in the future.  While requirements vary by country, company and business segment, every organization in the Biopharmaceutical space can benefit from the topics covered in this discussion.

Category:
Beyond Compliance

Level of Content:
Advanced

II-1 - Improving quality to reduce risk through the use of automation

Abstract: Automated tools can vastly improve the quality of data in clinical trials and registries, thereby increasing the evaluable data, ensuring valid results, and reducing labor. This session will discuss how to leverage advanced automation when using electronic data capture to ensure quality in the data for the project as a whole in the context of 21CRF11 "contemporaneous."
Modern systems can address site, user, and project level data in addition to subject data in an integrated way. These systems enable eSource by use of well-designed forms and navigation.
Systems that enable integrated feedback facilitate appropriate planning of comprehensive edit checks, logic and automated calculations. Automation can go beyond normal edit checks to include an integrated approach to randomization, inventory,  invoicing, laboratory interfaces, AE/ConMed coding, etc. By automatically generating information from other entries and configuration settings, errors can decline precipitously and monitors can focus on clinical issues.
Additional tools can automatically generate deviations, provide a smart look-up from dictionaries, build drop-down options from other entries, show trends to identify outliers, and take advantage of technologies such as bar code readers, RFID wands, specialized apps, etc. It is important to identify the variables and parameters that will be used to track risk and actions associated with each. Identifying these from the beginning allows automation and effective tracking within the system which result in improved quality. By planning for and automating these daily tasks, study management personnel’s time may be freed up to focus on continuous quality improvement initiatives. Learn how in this session.

Category: Biotechnology

Level of Content: Intermediate


II-2 - Evaluating and validating hosted electronic signature solutions  

Abstract: OECD 17 and 21 CFR Part 11 (including FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application) require that electronic signature solutions meet a host of requirements to ensure that the electronic signature is the equivalent of handwritten signatures. OECD 17 and 21 CFR Part 11 also require these electronic signature solutions be validated. More than fifty electronic signature solutions exist, but not all hosted solutions meet those regulatory requirements. It is the responsibility of users to validate, integrate, and determine if the hosted solution meets regulatory requirements.
The goal of this presentation is to review the following:

1. Brief overview of the applicable regulations
2. Points to consider when choosing a hosted signing solution
3. Integration of a stand-alone hosted electronic signing solution into existing workflows
4. Lessons learned during validation of a hosted electronic signature vendor

An introduction will provide a brief overview of the OECD 17 and 21 CFR Part 11 documents as they relate to electronic signatures. It will be assumed that attendees are familiar with the current industry best practices for computer system validation.

Category: Other

Level of Content: Intermediate


II-3 – SEND Update (pre-recorded video from Marc Ellison)

Category: SEND

Level of Content: Intermediate

RQAP re-registration units: 1 GCP, GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
This course will cover the full life-cycle of controlled process documents - from creation through archival. Topics will also include responsibilities, training, and non-compliance. Attendees should be prepared to bring examples of questions relating to SOPs (controlled process documents) and SOP management.

Objectives
At the end of the course, the participants shall be able to: 

• Understand the purpose and benefit of effective SOPs
• Understand the critical role of SOPs in Quality Documentation systems
• How to write a concise, unambiguous SOP for its intended purpose
• Define clear responsibilities to promote action and closure within the document
• Training requirements
• Manage revisions, nonconformance and deviations from a current SOP
• Difference between GCP/GLP/GMP

Target Audience
Anyone who is responsible for life cycle and compliance of these key components of the Quality Management System. This course is applicable to all; GMP, GCP, GLP, and GVP. This course is applicable for beginners as well as experienced personnel.

Agenda

• Understand the purpose and benefit of effective SOPs
• Understand the critical role of SOPs in Quality Documentation systems
• How to write a concise, unambiguous SOP for its intended purpose
• Define clear responsibilities to promote action and closure within the document
• Training requirements
• Manage revisions, nonconformance and deviations from a current SOP
• Difference between GCP/GLP/GMP

Class will include team exercises