Quality Reviews in the Context of FDA, EU and ICH Requirements and Expectations
- EU-GMP: which types of Quality Reviews are required?
- EU Quality System Review (overview)
- How to achieve EU-GMP compliance
- ICH/US-FDA view on the situation (overview)
- EU Product Quality Review (PQR)
- Technical terms and aims of PQR
- What documents and data should be reviewed?
- Are EU-requirements the same for APIs & medicinal products?
- What about US-FDA and ICH?
EU Product Quality Reviews in the Light of Inspections – Expectations of the Agencies
- Inspectors view on critical parts of EU-PQR
- Practical implementation and inspection
- PQR and contract manufacturing
- Comparison EU-PQR and US-APQR (inspectors point of view)
PQR and APR
- How to combine PQR and APR in an efficient way
- Well-proven PQR/APR designs
- Interface to Regulatory Affairs
- Certainties (PQR/APR in Custom Manufacturing, how to deal with limited numbers of batches …)
Set up of efficient PQRs and APRs
- How to profit from existing QA Systems in PQR/APR and vice versa
- Best practices
- Time/efforts needed
- Ongoing data collection
- Foreseeable complications/advantages
- Well-proven examples
Workshop: Evaluation of given PQR-Examples
Evaluate with other delegates the content and lay-out of given PQR-examples and discuss it with the speakers:
- What is useful?
- What is ambiguous?
- What could be improved?
- Definition, scope, objectives
- Participants, responsibilities
- Topics to be presented: input and output
- KPIs per system
- Examples and experience
Novo Nordisk Case Study: Management Review - from Data Collection to Evaluation and Reporting
- Collection and preparation of data: time/efforts needed, automatic vs. manual data capture
- Evaluation of deviations and changes
- Interpretation of data: what is the data telling us?
- How to report the data and information gained
Quality Reviews in Contract Manufacturing
- Customer QMRs - content, scope, frequency, organisation
- Interface with Business Management Reviews
- Assessment of data, trending and decision making
- Actions, follow-up
- „Face to Face“ or telecon?
Using KPI in Quality Reviews and in Communication with Authorities
- Current status of the requirements
- Key areas and data to be submitted
- How industry can prepare to meet the expectations
Review Management: Bringing them all together in an efficient Way
- How to set up an integrated data, review and report management
- How to avoid double work