Regulatory Seminars, Summits, Workshops and Conferences

Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)

Data Integrity: FDA/EU Requirements and Implementation

Writing and implementing a Standard Operating Procedure (SOP) in a Compliant Laboratory (US FDA, US EPA and OSHA Focus)

Quality Control Laboratory Compliance - cGMPs and GLPs

Preparing for FDA's New Import/Export Trauma in 2020

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions

Change Control Best Practices - Avoiding Unintended Consequences of Changes

HIPAA Privacy Rule Compliance-Understanding New Rules and Responsibilities of Privacy Officer

Managing Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Inspection

Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers

Design Control Essentials for Medical Devices

Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)

The Veterinary Drug Approval Process and FDA Regulatory Oversight

FDA's Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering

REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance

Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters

Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines

HIPAA Security and Breach Rule Compliance- Understanding Risk Analysis, Policies and Procedures and Managing Incidents

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Seminars

Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)

Data Integrity: FDA/EU Requirements and Implementation

Writing and implementing a Standard Operating Procedure (SOP) in a Compliant Laboratory (US FDA, US EPA and OSHA Focus)

Quality Control Laboratory Compliance - cGMPs and GLPs

Preparing for FDA's New Import/Export Trauma in 2020

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions

Change Control Best Practices - Avoiding Unintended Consequences of Changes

HIPAA Privacy Rule Compliance-Understanding New Rules and Responsibilities of Privacy Officer

Managing Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Inspection

Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers

Design Control Essentials for Medical Devices

Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)

The Veterinary Drug Approval Process and FDA Regulatory Oversight

FDA's Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering

REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance

Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters

Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines

HIPAA Security and Breach Rule Compliance- Understanding Risk Analysis, Policies and Procedures and Managing Incidents

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