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Always Inspection ReadyInspection Readiness
Are you ready for a regulatory inspection / customer audit?
PIC/s The Pharmaceutical Inspection Cooperation Scheme has scheduled a meeting for November 2020 in Thailand on “How to be a Good GMP Inspector.” You need to be ready to be a good GMP inspectee. Are you always inspection ready? Does your company have a corporate culture which requires operations to always be conducted as if an inspector is watching? Or...Continue reading
Have a question? We got all the answers
Issues to be covered
- Inspection Findings and Approaches: Plan – Do – Check- Act
- MHRA, FDA 483s and warning letters: what’s hot, what has changed?
- FDA Guide: Circumstances constituting refusal, denial, or delay of inspection
- FDA New Inspection Protocol Project (NIPP)
- Quality Culture Assessments: FDA vs MHRA approach
- Quality Metrics: altering behavior vs unintended consequences
- What are good metrics for “always inspection ready”
- GMP/GxP vs a continually improving PQS (Personnel Qualification Standard)
- Context of Your organization
- Process Mapping, QRM (Quantitative Risk Management), Data Governance
- Competent Subject Matter Experts (SMEs)
- How do you become competent and what does it mean: regulatory intelligence and updating
- PIC/s Inspectors Academy: Inspection Excellence through Harmonized Training
- CV vs Job Description vs Training vs Skills / Function Matrix
- Familiarity with material – hands-on
- Briefed in presenting
- Prepares summaries of complex topics / deviations / changes
- Revises constantly – internal audits challenge SMEs (Subject-Matter Experts)
- CAPAs for audits including coaching SMEs, including mock inspections
- Mock Inspection: Inspection Do’s and Don’ts – Learn Through Doing
Using real-life case studies and inspection transcripts (anonymous) collected through years of consultancy, this facilitated workshop allows participants y to test their skill at answering questions and presenting topics as SMEs. The mock inspection is a participant favorite. Those watching pick up “do’s and don’ts.” Behavior and responses are reviewed to learn how to do better in the real inspection. Inspection Handling SOP is discussed - Always Ready QMS (Quality Management System): What does it REALLY mean?
- Prevention: Practical, applied Risk Management
- Reaction for future prevention: Deviations and investigations
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- Eliminating the cause of unwanted, unexpected, undesirable events
- How to Evaluate / Demonstrate the Effectiveness of a PQS in relation to Risk-based Change Management: PIC/s 2019 draft guide NEW GUIDE
- WHO Data Integrity Guide 2019 NEW GUIDE
- DIRA: Data Integrity Risk Assessment
- Product Quality Review / Annual Product Review vs Continued Process Verification
- Lifecycle management: ongoing verification of process and analytical methods
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Who should attend
This course is suitable for:
- Anyone working in the pharmaceutical industry who will be part of a regulatory inspection
- Executive Management
- Subject Matter Experts (SMEs)
- QPs
- Quality Assurance
- Quality Control
- Other Quality Unit professionals
- Operations and Product Managers
- R&D
- Technology Transfer
- API and finished product manufactures
- Distributors
- Brokers
- Wholesale dealers or involved in the handling,processing or sale or administration of any of these
Benefits to the Participants
Participants will come away from this course
- Understanding the stress the inspector faces and will have a more focused approach to a regulatory inspection
- Appreciating the inefficiency of “preparing” for inspections, and the inherently better and cost-saving quality system which is “always ready” will allow a cultural shift
- Through understanding the regulator and FDA’s NIPP inspection program, participants will be better able to navigate the pre-inspection requests as well as having documents at their finger-tips to present to the inspector during the audit
- A subsidiary but far from trivial additional benefit: Customer audits, internal audits and vendor audits will all be more effective and better managed
About The Lecturer
