Seminars

Quality Control Laboratory Compliance - cGMPs and GLPs

  • Kelly Thomas
  • Virtual Seminar | January 13-14, 2021

21 CFR Part 11 Compliance for SaaS/Cloud Applications

  • David Nettleton
  • Virtual Seminar | January 27-28, 2021

Social Media Crisis Management

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Risk Management System in Medical Devices Industry

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Statistics for Quality Engineering

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Biocompatibility Testing for Medical Devices

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Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

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Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

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Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies

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Equipment and Utilities Qualification

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GxP/GMP and its Consequences for Quality Management, Quality Audit, Documentation, and Information Technology Systems

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

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The Risk-Based Approach to Pharmacovigilance Audits - A Practical Approach to Design and Implementation

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Building a Vendor Qualification Program for FDA Regulated Industries

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Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

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Recordkeeping and Documentation in a GLP Laboratory (US FDA, US EPA and OSHA Focus)

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eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada

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Latin America – Understanding Regulatory Compliance Requirements Across the Life Science Industry (Pharmaceuticals, Biologics, Medical Devices, IVDs)

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The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities

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