Webinar: Self Inspection
Course No 18150
Important: Deadline is 12 noon on 13 July 2020
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Speakers
Timur Güvercinci, Merck Healthcare KGaA
Background
Self Inspections are not only mandatory (EU-GMP Guidelines Chapter 9), the results and observations from self inspections also provide evidence of the effectiveness of the existing quality assurance systems. Self Inspection is a tool to assess and continuously improve the suitability and condition of systems, processes, equipment and premises.
But Self Inspections have their own character and require special planning, implementation and follow-up.
But Self Inspections have their own character and require special planning, implementation and follow-up.
Target Group
This webinar is aimed at auditors and managers from the pharmaceutical and API industry who plan, carry out and support self-inspections.
Technical Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programme
This webinar will give you important information on the following topics:
- Regulatory requirements
- Aim and purpose
- Department-, site- and corporate-wide inspections
- Requirements and success factors
- Methods
- Planning and preparation
- What should be taken into account during the inspection?
- Evaluation and reporting
- Follow-up measures
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
- Good Distribution Practice
- Sterile Manufacturing
- Computer Validation
- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- Impurities
- OOS / OOE / OOT
- Material Testing
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Microbiological Testing
- Technology
- General Manufacturing Topics
- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others