1. Summary of Leadership Criteria 2. Comparison of Medrad Industry & VA Clinical Research Pharmacy Coordinating Center 3. Compliance of Baldrige Leadership Criteria with FDA Quality Requirements NOTE - This presentation was made as part of an assignment for a Course PME 560 (Quality in Pharmaceutical Manufacturing) at Stevens Institute of Technology, Hoboken, New Jersey Prepared By - Sneha Chauhan, Dhaval Bhanushali, Jahin Amin and Kuldeep Badoniya

1. To Prepared by (Team1)
Prof. Pratt Sneha Chauhan
Kuldeep Badoniya
Dhaval Bhanushali
Jahin Amin

2. (1) Summary of Leadership Criteria
(2) Comparison of Medrad Industry & VA Clinical
Research Pharmacy Coordinating Center
(3) Compliance of Baldrige Leadership Criteria with
FDA Quality Requirements
(4) Team Opinion & Conclusion
(5) References

3. Leadership Section:
Leadership section examines how the organization’s
senior leader’s personal activities guide and sustain the
organization. Also examined are the organization’s
governance system and how the organization fulfills its
legal, ethical and societal responsibilities and supports its
key communities.
1.1 Senior Leadership:
 Describes how senior leaders communicate with the
Workforce and encourage high performance.
Sneha

4. (a) Vision, Values, and Mission
(1)Vision and Values:
 How do Senior Leaders set and deploy the vision and
values to workforce, key suppliers and partners, customers
and other stakeholders. How their actions will reflect a
commitment to the organization’s values.
(2) Promoting Legal and ethical Behavior:
(3) Creating a sustainable Organization:
 Create an environment for organizational performance
improvement, accomplishment of the mission and
strategic objectives, innovation.
Sneha

5.  Create a workforce culture that delivers a consistently
positive customer experience and fosters customer
engagement.
(b) Communication and Organizational Performance
(1)Communication:
 Encourage frank, two-way communication, key
decisions throughout the organization.
(2) Focus on Action:
 Creates and balances value for customers and other
stakeholders in their organizational performance
expectations.
Sneha

6. 1.2 Governance and Societal Responsibilities:
(a) Organizational Governance:
(1) Governance System:
 Accountability for the management’s actions.
 Transparency in operations and selection of and
disclosure policies for governance board members, as
appropriate.
(2) Performance Evaluation:
 Determining executive compensation.
Sneha

7. (b) Legal and Ethical Behavior:
(1) Legal and Regulatory Behavior:
 Key compliance processes, measures, and goals for
achieving and surpassing regulatory and legal requirements
and risks associated with the products and operations.
(2) Ethical Behavior:
 What are the key processes and measures or indicators for
enabling and monitoring ethical behavior in the governance
structure, throughout your organization, and in interactions
with customers, partners, suppliers, and other stakeholders.
Sneha

8. (c) Societal Responsibilities and Support of key
Communities:
(1) Societal Well-Being:
 How the organization considers societal well-being as a
part of strategy and daily operations and contribute to the
well-being of the environment of the organization, social
and economic systems.
(2) Community Support :
 Support and identifies key communities and determines
areas for organizational involvement and how senior
leaders contribute to improving these communities.
Sneha

9. Kuldeep 9
CRITERIA SENIOR LEADER’S APPROACH
• Setting and Deploying Vision and
Values
-To Employees
-To Stakeholders
• Reflectance to Values
• Promoting Legal & Ethical Behavior
• Creating Organizational Stability
-Performance Improvement
-Environment for Learning
-Workforce Learning
-Developing Leadership Skills
Distributed Leadership
Scorecard, Top 12, Recognition
Programs
Diverse Communication Methods
Active Participation in Meetings,
Business Reviews, Award Programs,
Field Visits
Participation in CEAB & LAB to address
Ethics Issues, Manage Patent Portfolios
Philosophy & Core, Scorecard, Employee
and Shareholder Interest
Strategic Planning, AB ownership
Participation in HRAB & SPP
Performance Management System

10. Kuldeep 10
CRITERIA (Contd.) APPROACH (Contd.)
• Communication
-Two Way
-For Key Decisions
-To Reinforce High
Performance, Customer &
Business Focus
• Focus on Action
-Creating & Balancing
Value for Customers &
other Stakeholders
Through ABs, meetings
and participation in
meetings and as a cross-
functional team
Department Meetings,
monthly CEO Highlight
Report, intranet
Sponsoring & presenting
awards within
departments
Strategic Planning &
Performance
Management
Philosophy, Mission &
Quality Policy

11. CRITERIA (Contd.) APPROACH (Contd.)
• Governance
-Ensuring Fiscal & Management
Accountability
-Independency in Audits
-Protection of Stakeholder Interest
• Societal/Educational Well Being &
Community Support
-Environmental Involvement
Through ABs, performance reviews,
ethics practices and PM systems
Compliance Group (Internal)
TUV/BSI for ISO compliance (External)
Regularity in reporting & auditing
Association with World Affairs Council,
Life’s Work, Habitat for Humanity,
Consolidated Distribution Operations,
providing internship/co-op to local
universities, supporting employee
championed community activities and
organizations
Energy use reductions, LEED Standards
for new buildings
Kuldeep 11

12. CRITERIA SENIOR LEADER’S APPROACH
• Setting and Deploying Vision and Values
-To Stakeholders
-To Employees
-To Suppliers
• Reflectance to Values
• Promoting Legal & Ethical Behavior
• Creating Organizational Stability
-Developing Leadership Skills
Reviewing employee input from SPEED,
discuss, develop, revise vision based on
inputs
Research publications, university faculty,
quality examiners
Conducting clinical trials, responding to
customer expectations, increasing
capability through FDA/ISO registrations
Face to face meetings, Quality Audits,
attending & presenting excellence
symposia
Personal Actions
Personal example, systematic checks and
balances, training
Balancing between VA and Extramural fund
Annual Management Training
Kuldeep 12

13. CRITERIA (Contd.) APPROACH (Contd.)
• Communication
-For Key Decisions
• Focus on Action
-Accomplishment of Organization’s
objective, Performance improvement
-Creating & Balancing Value for
Customers & other Stakeholders
• Governance
-Fiscal Accountability
-Accountability
-Transparency in Operations
• Societal Well being
Study team meetings, design reviews,
electronic media, one on one
SPEED, Center post information, Center
wide intranet, bimonthly all hands staff
Promoting employee involvement in
strategic planning cycle, periodic review
of health indicators.
Deploying a clear set of expectations for
managers and staff
In-depth financial audit
External Audits by FDA, DEA, CAP
Timely presentation of QIC review to
CEC/CMC
Trial & Center supported publications,
fellowships, Clerks man training
Kuldeep 13

14. Based on the fact that FDA did not find any regulatory
observations of non-compliance since many audits, it
can be concluded that the criteria of Leadership of both
organizations comply with the FDA Requirements.
Dhaval

15. •Medrad is well-known for medical devices
manufacturing and hence regulated by FDA through
21 CFR 820 regulations.
FDA quality Requirement:
- According to 21 CFR 820.20 Subpart B,
establishment of quality policy and objectives
in the organization which shall be understood,
implemented and maintained at all levels of
organization. Dhaval

16. - It’s own quality policy, known as Medrad Quality
Policy.
- To improve the quality of the products and services
continuously.
Dhaval

17. - According to 21 CFR 820.20 Subpart B, establishment
and maintenance of organizational structure to ensure the
produced devices are designed and produced in accordance
with the requirement.
- Appropriate responsibilities and authorities, resources,
management representatives.
Medrad’s Compliance :
- Establishment of organizational structure by distributing
leadership.
- Advisory board composed of senior staff members, middle
managers and expertise for each area.
- Distribution of responsibilities with different departments.
- Limited but qualified suppliers.
-Product development teams, senior staff, Operations,
Configuration Control Board, Regulatory Affairs (to comply
with regulations and to monitor day by day activities).
Dhaval

18. - According to 21 CFR 820.20 Subpart B, High level
management shall review the suitability and
effectiveness of the quality system at defined interval
with the documented evidence.
Medrad’s Compliance:
- Establishment of two way communication system
- Discussion about the quality policy and other related
information with every level of management.
- All employees review and signed the quality policy
annually.
- Training and presentation seminars at regular interval.
Dhaval

19. - According to 21 CFR 820.20 Subpart B, each
manufacturer shall establish the quality system
procedures and instructions.
Medrad’s Compliance:
- Systematic regulatory framework involving the
experts from every level of organization.
- Handling of quality issues, CAPA, internal & external
complains, risk assessment.
Dhaval

20. - According to 21 CFR 820.22 subpart B, each
manufacturer shall establish the quality audit
procedure for assurance of compliance of quality
system with the regulations.
Medrad’s Complaince:
- Internal audits conducted by the internal auditors and
experts from outside annually reporting to regulatory
department of the Organization.
- Company invites voluntarily the auditors from other
regulatory agencies.
- Assessment of CAPA by the regulatory department.
- Dhaval

21. - According to 21 CFR 820.25, each manufacturer
shall have sufficient personnel with necessary
education, background, training and experience.
Medrad’s Compliance:
- More than 2000 employees
- With different backgrounds
- Degreed, non-degreed workers for assembly and
production area.
- Employees with college degree and advanced degree
- for all professional and management level.
Dhaval

22. VA Cooperative Studies Program Clinical Research
Pharmacy Coordinating Center Supports and
manages drug-related activities in clinical trials and
hence regulated by Good Clinical Practice (GCP)
regulations.
Jahin

23. - According to GCP, establishment of quality system &
organizational structure.
VACSP Compliance:
- Quality Technology Systems: eQMS, La Peurta &
ERP, Processing software
- Systematic organization structure of Project
Management along with regulatory department.
Jahin

24. - According to GCP, record of training about Good
Clinical Practices.
VACSP’s Compliance:
- Training sessions about GCP and GMP for all the
employees two times in a year with documented
evidence.
- Annual training sessions for upper level management
regarding innovations and current trends.
Jahin

25. - Neutral audits to check the compliance with the
regulations.
VACSP’s Compliance:
- External independent audits by FDA, Drug
Enforcement Administration (DEA) and
College of American Pathologists (CAP)
- Internal independent audits by the company’s auditors.
- Audits against written SOPs and approved methods,
procedures and protocols.
Jahin

26. - According to 21 CFR 50, sponsor shall protect the
human subject throughout the clinical trials.
VACSP’s Compliance:
- Extensive review of clinical trial protocols by project
manager and project director before initiating the
clinical trials to address the possible adverse effect.
- Clinical trial reviews by Institutional Review Boards
(IRBs).
- Safety addressing through the Site monitoring,
auditing and Resource teams. Jahin

27. Is it worthwhile for a company to pursue the
Baldrige quality award? OR Does it take
away anything from anything from FDA
efforts?

28. Because,
1) Highest level of recognition.
2) Benchmarking the desired parameters.
3) Setting short term and long term goals and objective
or refinement and alignment with core
competencies.
4) Designing of efficient strategies and effective
implementation.
5) Better organizational structure and communication.
6) Total quality management, agility and innovation.
7) Strengthening companies key communities.
8) Better customer relationship managements.
Sneha, Kuldeep, Dhaval, Jahin

29. http://www.baldrige.nist.gov/PDF_files/Medrad_Application_Su
mmary.pdf
http://www.baldrige.nist.gov/PDF_files/2010_MEDRAD_Award
_Application_Summary.pdf
http://www.baldrige.nist.gov/PDF_files/VACSP_Award_Applica
tion_Summary.pdf
http://www.nist.gov/baldrige/publications/upload/2011_2012_Bu
siness_Nonprofit_Criteria.pdf
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSea
rch.cfm?CFRPart=820&showFR=1&subpartNode=21:8.0.1.1.12
.2
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearc
h.cfm?cfrpart=50&showfr=1
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSea
rch.cfm?fr=812.5