Life

Science Quality Outlook

2020: Goals, Challenges & Expert
Perspectives

The FDA Group Webinar

J. Lawrence Stevens, RAC
Senior Regulatory/Quality Consultant

The FDA Group | (508) 926-8330 1

The FDA Group, LLC

• A global leader in life science staff augmentation, recruitment, remediation,

and auditing.

• We have a large staff of life science resources –– former FDA investigators,

officials, reviewers, and industry experts.

• We service the following industries:

• Pharmaceutical

• Biotechnology

• Medical Device / Diagnostics

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Agenda

We’ll be reporting survey findings and offering

perspectives into the following areas, with a Q&A
afterward:

1. Quality Objectives in 2020

2. Obstacles to Achievement

3. Quality System Challenges

4. QMS Priorities

5. Quality Resourcing

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About the Survey

• Throughout Q4 2019, we surveyed a

total of 27 life science quality leaders in
organizations large and small.

• Our goal was to reveal trends

concerning goals, challenges, and
strategies among quality teams in 2020.

• A PDF version of the report will be sent

to all registrants along with this slide
deck.

• Let’s explore the findings…

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Quality Objectives

TREND #1

Compliance & production represent the top

quality goals in 2020.

What are your top quality objectives for 2020?

• Maintaining compliance: 90%
• Improving mfg. performance: 63%
• Bringing new products to market: 46%

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Quality Objectives

The FDA Group | (508) 926-8330

Quality Objectives

Considerations for Quality Leaders:

• Do you have an enterprise-wide view of your compliance

risks?
• Does you CEO see you as a business partner?
• Do you have opportunities to optimize compliance
effectiveness or efficiency?
• How can your compliance function become more mature
in 2020?
• Do you have the dedicated local resources to maintain
compliance across the organization?
• Are you prioritizing preventive action or taking a reactive
approach to compliance?

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Obstacles to Achievement

TREND #2

Resourcing and budget are expected to be

significant obstacles to success.

What are the 1-3 top obstacles to achieving

your objectives in 2020?
• Limited headcount: 63%
• Limited budget: 50%
• Limited skillsets: 45%

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Obstacles to Achievement

The FDA Group | (508) 926-8330

Obstacles to Achievement

Considerations for Quality Leaders:

• Does staffing pose compliance risks in 2020? (Does

your quality unit meet FDA expectations?)
• Do you have strategic quality objectives?
• Will staffing issues challenge any of your projects or
goals set for 2020?
• Will contracted resources be needed to fill gaps or
augment your team throughout the year?
• Does your CEO support Quality System
improvements?

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Quality System

TREND #3

Compliance and resourcing are the biggest

upcoming challenges within the quality system.

What are 1-3 of the biggest current or upcoming

challenges to your quality system?
• Ensuring compliance with relevant regulations: 73%
• Sufficient staffing/resourcing: 66%
• Supplier management: 41%

The FDA Group | (508) 926-8330

Quality System

The FDA Group | (508) 926-8330

Quality System

Considerations for Quality

Leaders: Most Frequent Warning Letter Citations in Fiscal Year 2019

• Is your quality system at Drug Device

risk of trending issues? 1. Responsibilities of the quality 1. CAPA (21 CFR 820.100
unit (21 CFR 211.22) 2. Design controls (21 CFR 820.30)
• Again, is your quality unit 2. Written procedures; deviations
(21 CFR 211.100)
3. Purchasing controls (21 CFR
820.50)
adequately staffed to meet 3. Testing and release for 4. Process validation (21 CFR
distribution (21 CFR 21.165) 820.75)
the demands of your 4. Production record review (21 5. Complaint files (21 CFR
quality system? 5.
CFR 211.192)
Testing and approval or
820.198)

rejection of components,
containers, and closures (21
CFR 211.165)

The FDA Group | (508) 926-8330

QMS Focus

TREND #4

Quality teams have mixed QMS priorities, but documentation, risk

analysis, and CAPA stand out.

Which 3 QMS elements represent areas of greatest focus in 2020?

• Documentation: 43%
• Risk analysis: 40%
• CAPA: 40%

The FDA Group | (508) 926-8330

QMS Focus

The FDA Group | (508) 926-8330

QMS Focus

Considerations for Quality Leaders:

• Is your document control system effective and ready to

take on new activities in 2020?
• Have you invested in a computer based document
control system? And as a result reduced staffing?
• Is your risk assessment program as wide as it needs to
be? (Does it encompass hazard identification, risk
analysis, control implementation, and performance
evaluation?)
• Is your CAPA program effective, or does is suffer from
common issues that lead to potentially dangerous
delays?

The FDA Group | (508) 926-8330

Quality Resourcing

TREND #5

Most quality teams see resourcing as a

challenge in 2020 and prioritize fit, skills,
knowledge, and expertise over rate in
potential candidates.

What are your 1-3 top considerations when

evaluating a recruitment/staffing/consulting firm?
• Right-fit skills and knowledge: 86%
• Industry-specific experience and expertise: 73%
• Price/rate: 53%

The FDA Group | (508) 926-8330

Quality Resourcing

The FDA Group | (508) 926-8330

Quality Resourcing

Considerations for Quality Leaders:

• Have you evaluated your resourcing needs for the year

ahead in terms of both headcount and skillsets?
• Are your position descriptions accurate and up to date?
• Will upcoming projects or organizational changes result
in resourcing challenges?
• Do you have a resourcing firm that can rapidly identify
contracted candidates or direct hires based on who you
need and where you need them?

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 QUESTIONS?

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 Thank You
Contact the experts at The FDA Group

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The FDA Group | (508) 926-8330