Edward Daniel Email & Phone Number

Nazareth, PA, US

Acted as client representative overseeing processing engineering, calibration, and facility management. Led FDA submission processes for both the facility and drug product.Conducted comprehensive quality audits using FDA's risk-based approach. Identified gaps and provided actionable recommendations to enhance compliance and quality standards.Directed C&Q.

Blue Bell, PA, US

• Leadership and Oversight: Directed comprehensive Cleaning and Process Validation initiatives, ensuring adherence to GxP standards across critical projects.
• Client #5: Managed the construction and C&Q activities for a new manufacturing facility. Validated 82 systems and utilities, including complex robotic and EM isolator systems. Implemented single-use equipment.
• Client #4: Conducted a thorough 3rd Party Quality Audit following FDA 483 Observations. Directed remediation efforts, including surface area calculations, worst-case soil evaluations, and cleaning cycle development..
• Client #3: Provided expert consultation for the Kneat software implementation, digitizing validation, commissioning, and qualification processes. Collaborated with cross-functional teams to customize the software and.
• Client #2: Managed C&Q activities for a new manufacturing facility, covering 190 systems and utilities. Applied Quality Risk Management (QRM) to determine Environmental Monitoring (EM) locations for validation..
• Client #1: Led Phase 1 construction and C&Q for a remodeled facility, establishing a robust Quality Management System (QMS). Directed validation efforts to ensure compliance with regulatory standards and industry best.

• Led validation projects, ensuring compliance with regulatory standards and developing tailored validation strategies for clients. Managed project teams and client relationships.
• Client #2: Managed Quality FMEA for a penicillin manufacturing facility. Established corrective actions, led remediation efforts, and developed comprehensive reports.
• Client #1: Oversaw project budgets and new developments, including cleaning validation activities for vaccine manufacturing. Managed a $2.5M budget and ensured regulatory compliance.

US

Managed cleaning validation for multiple manufacturing facilities. Developed and executed cleaning validation protocols, supervised team members, and established robust QMS for Cleaning Validation.

Switzerland 🇨🇭, CH

Designed and executed stability studies and process validation for various manufacturing processes. Conducted cleaning validation and facilitated production and QC testing.

Education record

Education record