Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries)

Description

Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries) is a conference that provides knowledge on how to select, qualify and monitor CMOs, CROs and Contract Laboratories.

Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries) covers topics such as:

  • How to select , qualify and monitor CMOs, CROs and Contract Laboratories
  • GMP and GCP requirements all virtual companies must meet regardless of the extent of their outsourcing operations
  • How to determine which GMP or GCP requirements apply to you, depending on the things you do internally and those you outsource
  • The elements to include in a quality agreement (also known as a technical agreement)
  • The importance of maintaining data integrity
  • Your obligations under the law for products you release to the clinic or the marketplace
  • Inspection logistics
  • How to effectively manage a health regulatory inspection:
  • Managing the inspection exit discussion
  • Responding effectively to document requests and questions from inspectors
  • How to find applicable inspection references and procedures of the FDA, EMA and Health Canada
  • How to write an effective response to inspection observations

Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries) brings together:

  • Quality professionals
  • Senior quality managers in manufacturing QA/GMP or clinical quality areas
  • Clinical Operations
  • Regulatory professionals
  • Quality auditors – GMP and GCP
  • Compliance professionals
  • Document control specialists

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Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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