042 - “Half Knowledge Can Hurt” with Shadeed Salam

On this episode of the podcast, I was joined by Shadeed Salem, the Founder and President of Synergy Bioscience. Shadeed and I discuss:

• War Stories in method validation and NCR/OOS's
• What is it that you're going to test and what are you testing for?
• Differences between drug and device methods
  • Analytical Method
  • Visual Inspection
  • Physical Test Methods
  • Mechanical Test Methods
• Method Development vs. Method Validation
• How to treat compendia methods (USP, ISO, etc)
• Specificity, Bias, Linearity, Gage R&R

Shadeed Salem MSc MBA CQE CQMOE CQA CSSBB CPGP is an industry matter expert with proven expertise in the establishment and remediation of quality systems based on regulatory requirements such as the FDA 21CFR 210, 211, QSR 820, ISO 9001, ISO 13485, ISO 14971, ISO 14644, and IEC 60601 and guidelines such as ICH, WHO, and PIC/S for pharmaceutical and medical device industries. Thorough knowledge and high level of expertise in writing protocols and implementing numerous validation studies such as Analytical Method Development/Validation, equipment qualification (IQ/OQ/PQ), Cleaning Validation, Cleanroom Qualification, Water System Qualification, as well as manufacturing process validations. Exceptionally skilled in performing Corrective Action / Preventive Action (CAPA) and Root Cause Analysis, Out of Specifications (OOS) Investigations, quality system auditing and compliance gap assessment, as well as providing training based on cGMP requirements.