GMP Training: GMP Audit,EU GMP,FDA cGMP,FDA Certification,GMP Consulting,GMP compliance ,FDA Program,Globepharm Consulting

Globepharm - eLearning

Meet Michael H. Anisfeld

30 years world-wide pharaceutical industry expertise in all aspects of GMP compliance and quality assurance. We know the FDA and we know what it takes to comply with GMP regulations.

Biography

Mr. Michael H. Anisfeld has worked in the pharmaceutical industry internationally for 30 years, and specializes in aspects relating to Good Manufacturing Practices and Quality Matters. He has been involved in many "expert witness" situations and has depostion experience. His expertise extends to pharmaceuticals, active pharmaceutical ingredients and biotechnology products. Mr. Anisfeld holds Masters degreees in Pharmaceutical Technology (M.Sc.), Business Administration (MBA) and Management Science (MSM), as well as a Diploma in Middle East Studies (DMES). As well as English, Mr. Anisfeld speaks French, and Hebrew; and can perform GMP audits in German and Italian.

Consulting Services

Globepharm Consulting offers your company a range of services :

	Cost-effective internal Quality/GMP compliance audits, litigation testimony and vendor/supplier inspections
	Mock-FDA PAI and GMP Inspections of biotechnology, diagnostics, pharmaceutical and API manufacturers
	"Due Diligence" activities include inspections prior to company acquisitions
	Quality/GMP Expert Testimony in court cases
	QA and QC Systems Audits;
	Supplier and Vendor audits;
	Facility Design and Facility Design Critiques
	Other GMP-related activities

List of eLearning Courses

	Preparing For, and Passing, an FDA Inspection
	FDA Program
	Managing the QC Laboratory in a GMP Compliant Manner
	Managing QC Laboratories in a GMP Compliant Manner
	Fundamentals and Essentials of Validation
	Fundamentals and Essentials of Validation
	Effective Investigation and Corrective Actions(CAPA)
	Proper investigation of quality events
	Effective Quality Assurance Auditing
	Effective quality assurance auditing

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Our Credo

"If we can get our clients to the point where they no longer need our services, then we have been successful" - it's as simple as that.