Consulting:

 Regulatory Compliance Consultant to the Pharmaceutical, Biologics and Medical Device Industries including Combination Products

Perform CGMP and mock - Pre-Approval audits of international and domestic drug manufacturers and identify deficiencies that potentially could have regulatory and administrative impact

Review of Corrective And Preventive Action (CAPA) plans, Process and Equipment Validation Protocols (IQ/OQ/PQ), Technical Transfer Documentation, Analytical Methods Transfer Documentation, Formal responses and correspondences with FDA, and Quality Policies and operating procedures that comply with FDA regulations and expectations

Review of Environmental Monitoring programs for aseptic manufacturing environments and non-sterile manufacturing facilities

Perform GAP Assessments for critical compliance issues and functions within a pharmaceutical, biological and medical device facility

Develop strategies for FDA Readiness for both Pharmaceutical, biological and Medical Devices

Present formal and informal training seminars covering FDA expectations on various topics which includes satisfaction of annual GMP training

Review of Critical non-compliance deviation reports including Out of Specification reports

Training:

1.  Pre-Approval Inspections

2.  GMP Training

3.  Preparing for FDA Inspections  

4.  Root Cause Analysis

5.  Potent Compounds

6.  Managing Risks

7.  Effective Corrective Actions

8.  How to Audit Effectively

9.  Investigation Writing

10. Combination Products - under development

11. GXP's

12. ICH Q-10 (short topic)

13.  Line Clearance