Observations by inspectors regarding documentation non-compliances are among the most frequent.
The “Documentation Inspection Readiness” training course aims to illustrate, through case studies, the key points of document management activities and analyse the inspector’s expectations on BPR process documentation. Useful tools will also be provided, to better interpret and respond to comments from Regulatory Agencies (AIFA, FDA and others).
A training course full of practical examples to understand the major critical issues related to the management of “Batch Production Record” process documentation, in order to identify improvement points in terms of both document redesign and document management.
Key points of the training
- Most common regulatory issues on document deficiencies
- How to perform a gap analysis
- Documentation redesign: easy to use and "inspector" proof
- Methodologies for continuous improvement
- KPIs and efficiency and effectiveness of document review processes
09:30 – 12:30 MORNING SESSION
14:00 – 17:00 AFTERNOON SESSION
- Structure of a Process Document.
- Major observations encountered and reported during inspections (483 and AIFA observations)
- Introduction to document review management- gap-analysis
- Verification of the type of error and coding of the same
- Practical examples of error types and how to achieve effective and efficient documentation
- Organization of the “war room” to effectively manage the document request at the inspection stage
- Question and answer session
- Performance indicators and improvement
- Error coding and error tabulation
- Realization of process KPIs and calculation of review times
- Verification of the process document Vs what was performed in the field
- Supervision, correction and approval of documentation
- Implementation of continuous documentation improvement methodologies
- Practical examples of reviewing a process document
- Question and answer session
QA Manager, CQ Manager, Production Manager, Microbiology Manager, Validation Manager, Audit Manager, Documentation Specialist.
The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.
For online trainings the access link will be sent 2-3 days before the start of the training.
5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.
In order to cancel enrolment to an event, please email email@example.com within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.
It is possible to replace a participant attendance without additional cost, simply by contacting firstname.lastname@example.org. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.
If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.
Qualification Transformation Engineering Manager at GSK Vaccines
Graduated in Industrial Chemistry and Biology at the University of Siena, he began his working career at ENI and Solmine in June 1988 as supervisor of the chemical laboratory and raw materials specialist. He began his work experience in Sclavo/Chiron – Vaccines (now Novartis VND) in July 1996, as “Quality assurance expert”. In this position (from 1996 to 2001) Pranti deepened his experience on aseptic processes (formulation, filling and inspection of vaccines in liquid and freeze-dried form) and packaging for commercial production (with management of deviations, change, SAP, LIMS and batch record review). From 2001 to July 2007, he was “Senior Specialist” for a project to implement a new department dedicated to aseptic activities, deepening in this position the skills related to engineering and validation aspects (FAT, SAT,), problem solving and to the Quality and Compliance aspects of aseptic activities. From 2007 to today, he has been working in the Product Assurance Aseptic Process sector as a manager with qualitative responsibilities related to the aseptic area for the new NVD Department, coordinating a team of 24 people. Over the years, Pranti has gained in-depth experience in continuous improvement, problem solving, team management, quality risk management, sterility assurance and GMP compliance aspects.
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