Senior Staff

Alan A. Waldman, Ph.D.

	President, 1988-present, of Waldman Biomedical Consultancy, Inc., an international advisory group he founded in 1988.
	Acts as lead consultant, with responsibility for project design, task definition and staff assignments.  Working with colleagues in senior management at client companies, and Consultancy staff, have provided project leadership and hands-on management of:
	product definition and manufacture, including all aspects of outsourcing creation and coordination of global quality and regulatory strategies operation of Quality and Regulatory units documentation and control of routine production qualification and validation of facilities, operations and testing development of new products and scale-up of production audit and review of facilities and quality operations assuring compliance with GMP and ISO performance and analysis of pre-clinical and clinical trials all types of filings, meetings and other interactions with regulatory agencies responses to inspection findings and warning letters U.S. Agency for international companies
	Technical Director, 1981-1988, of the $100,000,000/year multi-Divisional New York Blood Center, largest in the world
		Responsible for systems development, Quality Control, Quality Assurance, and Regulatory Affairs at the Center.
		Conducted formal, FDA-style inspections at FDA-licensed facilities in the United States and throughout Europe.
	Head, Cellular Products Division and Cellular Components Laboratory, New York Blood Center, 1976-1988.
		Led development of new Division, and initiated large-scale production and licensure of human interferon.
		Successful competitor for contracts in areas as diverse as production of human interferon, creation of new hepatitis assays, and analysis of the causes of AIDS.
	Head or member, scientific advisory board of major diagnostic manufacturers. Author of over 60 reports and publications.
	Author of Discovered Global Wisdom and Adventures in Global Consulting
	Member AABB, PDA, RAPS Education
	Ph.D., Graduate Dept. of Biochemistry, Tufts University B.S., Department of Chemistry, Brooklyn College

Senior Consultant, Regulatory Affairs, 1989-present
34 years of experience in all aspects of regulatory affairs.
Areas of expertise:
Preparation and submission of regulatory documents of all kinds, including
PMAs, NDAs, and 510(k)s
Regulatory audits and inspections
Review of GMP and ISO compliance status
Systems and labeling development
Initiation and monitoring of clinical investigations
Premarket approval applications, listings, licenses, and registrations
Technical writing for protocols, brochures and publications

Senior Legal Advisor, Intellectual Property, 1988-present
31 years of experience in all aspects of intellectual property management
Areas of expertise:
Intellectual property protection, including patents, trademarks and copyrights
Evaluation and control of proprietary information
Technology transfer agreements

Senior Consultant, Bioscience and Biotechnology, 1988-present
28 years of experience in management of applied research and regulation
of science and technology
Areas of expertise:
Technology evaluation and development
Systems development and documentation
Technical and educational training program development and implementation
Creation of inspection and proficiency testing programs
Regulatory audits and inspections
Problem solving for quality control issues

Senior Consultant, Marketing and Sales, 1988-present
28 years of experience in development and conduct of marketing strategies,
and in building of sales for companies
Areas of expertise:
Analysis of current and future markets for biologics, devices and drugs
Negotiation of marketing agreements
Import/export arrangements
Building of market presence
Development of channels for marketing and distribution

Senior Consultant, Project Management, 2001-present
29 years of experience in managment of construction and equipment installation projects
Areas of expertise:
Technology evaluation and development
Systems development and documentation
Technical and educational training program development and implementation
Creation of inspection and proficiency testing programs
Regulatory audits and inspections
Problem solving for quality control issues

	Senior Consultant, Compliance, 2004 to present
	34 years of experience in all aspects of Compliance and Quality Systems
	Areas of expertise include:
		development of Quality Manuals, all documentation systems, including, SOPs, SCPs (analytical methods), raw materials specifications, master production and control records, container/closure system specifications, and in-process and finished product specifications
		creation and review of general and product specific chemistry, manufacturing and controls (CMC) documents
		facility qualification, including preparation and execution of protocols, collation and review of data, and preparation of Executive Summary Reports on DQ/IQ/OQ/PQ of equipment and  utilities (HVAC/WFI/clean steam/ environmental control)
		manufacturing process validation, including for solid, semi-solid, liquid, and aseptically-filled sterile liquid and lyophilized products, and the related cleaning and analytical method validation
		development and utilization of systems for review of production batch records and analytical data, for product release, for review of stability data, and for creation of Annual Reports
		creation of systems for handling of manufacturing deviations, OOS findings, product complaints, product recalls, and annual product reviews
		introduction and conduct of program for internal and pre-approval inspections, and vendor, CRO and CMO audits
		assuring compliance with GMP and ISO, including training programs for manufacturing and support personnel in cGMP, GLP and GCP
		performance and analysis of pre-clinical and clinical trials
		liaison with FDA and international regulatory agencies, including all types of filings, submissions, meetings and other interactions