Developing Quality - United we Stand, Divided we fall

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RQA conference 9‐11 November 2022 Quality RE:UNITED Speaker: Christine Mitchell ChrisalisQAdvice

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Developing Quality ‐ United we stand, divided we fall

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My background

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• More than 35 years experience in regulatory Quality Assurance in a multi‐national CRO • Since 2020 Independent Consultant ChrisalisQAdvice • Hobbies: Travel and scuba diving

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Focus • Developing quality: • Obstacles and challenges • Solutions • QBD

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• Improving quality:

What is Quality?

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• Monitoring process and product quality • Change control • Improvement plans • Verification and celebration of success

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The degree to which an object or entity (e.g. process, product or service) satisfies a specified set of attributes or requirements.

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Developing means….

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Growing and becoming more mature, advanced or elaborate.

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The learning cycle

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I think I know what I’m doing

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I thought I knew it , but I don’t

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I’m willing to learn

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I feel confident

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Know what you need to deliver

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Ask Ask Ask!

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Knowledge is power but sharing is even more powerful

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Tools Artificial Intelligence Q‐Data AI FDA Warning letters

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QA websites/meetings

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Q‐Data

Guidelines and regulations

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EMA Scientific Advice

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Governmental blogs

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Begin with the end in mind and know how to get there

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Drug Development Road Map Pre‐Approval

Approval

Post‐Approval

Clinical

Non clinical

Phase IV

Production

Lab Scale

Pilot Scale

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RA Dossier

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Phase III

Post‐Market Surveillance

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Phase II

Phase I

Commercial Scale

Full Scale

Maintenance

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Approval

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Common Technical Document

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Keep on moving, even if things get tough

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2EVWDFOHV DQG FKDOOHQJHV

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• %((1 7+(5( • '21( ,7 • *27 7+( 7 6+,57

“I don’t underststand the regulations”

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“No one ever gives me support when I want to do something new”

“We have already had so many new initiatives this year. I really don’t have time to do my core duties …let alone improve!”

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“I do not really know our quality level at present so how can I improve?”

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“We just cannot finance any improvements at present.”

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Research and development

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Obstacles and challenges: • Lack of awareness of the importance of the work for later stages in development.

• Lack of data integrity knowledge.

• Researchers want to know everything.

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Solutions: • Educate researchers and developers on the importance of their work and next steps.

• Provide structure for data and training on data integrity.

• Focus on what matters, but embrace innovation.

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Small start‐up companies

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Obstacles and challenges: • Lack of funding.

• Lack of expert knowledge in specific areas.

• Over complicated QMS. Solutions: • EMA fee reductions and grants for SMEs. • Grow your network • Make use of EMA Scientific Advice.

• Keep the QMS simple. Less is more.

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Large global internationals

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Obstacles and challenges: • Global quality systems (does one size fit all?).

• Overload on new systems.

• Lack of sharing of information (“what’s developed in the UK stays in the UK”).

• Oversharing of information (the email waterfall!).

• Multiple approvals leading to long start‐up times.

• Cultural differences in the workforce.

• Keeping long‐term staff motivated.

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Large global internationals

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Solutions: • Don’t break what isn’t broken! Embrace the QMS that has proven to work.

• Assess the risk/benefits before introducing new systems.

• Develop multi‐disciplinary teams (include regulatory affairs).

• Emails: think before you send!

• Embrace the benefits of cultural differences.

• Buddy up experienced and less experienced staff.

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Quality by Design (QBD)

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QBD can be applied universally across all GXPs • Understand your critical phases (GLP) • Understand your critical quality attributes, processes and parameters (GMP) • Understand critical to quality factors (GCP) • Control what you can and know what you can’t

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Monitoring Process and Product Quality

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What are the risks and benefits?

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“If a thing is worth doing it is worth doing well!”

Chinese proverb

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Product and Process Quality Monitoring • Product quality • Staff pass with a grade of 80% or higher

Staff training

• Process quality • At least 90% of staff pass per year

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Staff training

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United we stand…divided we fall

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The battle for improvement

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• A well thought through plan will win the battle • Never go it alone, you will need support from many sides • Collaborate on all levels (include the soldiers and not just the generals)

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Implementing improvement

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Change control

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“Each improvement requires a change, but not all changes lead to improvement!”

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• Reduces the chances of unnecessary changes.

• Helps manage risk.

• Know who needs to approve change.

• Consider: • Are there legal restrictions?

• How will the changes impact the present processes/products/services?

• How will the changes impact staff?

• What resources are required for the change?

• Will the change bring new risks, problems or new opportunities?

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Improvement plans

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• Know your obstacles and challenges.

• Don’t make the project too long/too big.

• Include your influencers.

• Include clients (external/internal).

• Set up a communication plan.

• Use SMART goals to define success.

• Indicate how success will be monitored.

• Include follow‐up verification.

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Follow‐up verification

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• Who will be involved?

• What will be measured/assessed?

• What reports are needed?

• Who will assess/review the reports?

• How will the outcome be communicated?

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Give encouragement • Communicate the outcome

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• Learn from the process

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• Reward staff for their input

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Celebrate Success

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When developing quality, understand what’s important, know your challenges and how to deal with them.

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What will this baby be doing in 30 years time?

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THANK YOU FOR JOINING THE SESSION

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RQA conference 9‐11 November 2022 Quality RE:UNITED Speaker : Christine Mitchell ChrisalisQAdvice www.chrisalisqadvice.com Christine.Mitchell@chrisalisqadvice.com

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Questions?