Good Documentation Practice compact - Training / Workshop von PTS Training Service

Overview on required GMP documentation presented in English language Document Management System Different types of documentation (from Instructions to Reports) How to record correctly Significance of signatures From development of documents to archiving o

Inhalte

Good Documentation Practice

A well-founded understanding of GMP-compliant documentation is important for all GMP- and GDP-related areas. This training has been designed to present an overview of the required GMP documentation as well as the responsibilities of the individuals dealing with the different types of documentation. API manufacturers, excipient manufacturers and service providers can also benefit from a basic knowledge of documentation requirements. It guarantees an optimal service for the pharmaceutical industry.

Lernziele

  • Basic information
  • Regulatory requirements in Switzerland, EU, USA
  • Purpose of GMP documentation
  • Good Documentation Practice
  • Document management system
  • Special documentation
  • Quality manual
  • Site master file
  • Registration/Marketing Authorisation documentation
  • Instructions and records
  • Manufacturing formulae
  • Processing, packaging and testing instructions
  • Specifications
  • Batch records
  • Protocols
  • Records, reports
  • Certificates
  • Logbooks
  • SOPs
  • General requirements
  • Structure and content
  • SOP management
  • Change
  • Archiving
  • GMP compliance
  • Responsibilities
  • Issue check release
  • Significance of signatures
  • Double check, four-eyes principle
  • Corrections
  • Raw data
  • Deviations
  • Workshop on evaluation of deviations
ReferentenDr. Josef Landwehr, PTS Training Service

Zielgruppen

Personnel who: are involved in the management of documentation, issue and maintain GMP documents, issue, check or approve SOPs, prepare protocols and records, maintain logbooks, archive documents

Termine und Orte

Datum Uhrzeit Dauer Preis
Wiesbaden, DE
20.04.2021 10:00 - 17:00 Uhr 6 h Jetzt buchen ›

SG-Seminar-Nr.: 5588222

Anbieter-Seminar-Nr.: 3878

Termine

  • 20.04.2021

    Wiesbaden, DE

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Datum Uhrzeit Dauer Preis
Wiesbaden, DE
20.04.2021 10:00 - 17:00 Uhr 6 h Jetzt buchen ›