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1. FDA Guidance for Industry. Q10 Pharmaceutical Quality Systems. April 2009.

2. International Council for Harmonization. Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. November 2019.

3. Diane Harper, Applying ICH Q12 to Combination Products. American Drug Delivery & Formulation Summit. 2019

4. Susan Neadle, Combination Products GMP and Controls Strategies. Xavier Health Combination Products Conference. 2018

5. Julien Klein, Developing a Combination Product Control Strategy. PDA Europe Prefilled Syringes Interest Group Webinar. 2021

6. Nuha Al-Hafez, et al., Holistic Control Strategy: From ICH Quality Guidelines to Pharma 4.0. ISPE Pharmaceutical Engineering. 2021

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Fran DeGrazio

Fran DeGrazio

Chief Scientific Officer

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