As, you all are aware about current pandemic transmission of COVID-19, a novel corona virus. To control the transmission and to get rid of this problem government of all countries has taken lot of steps. One of the step is lock down and restrictions on the people gathering, local transportation etc.
Now considering the current situation Pharma manufacturing is considered as essential services and still working during this period. But one point we should not forget that considering the current situation the Pharma companies are running with some practical problems which may be directly or indirectly impact on the compliance level of the products manufactured during this period and overall cGMP compliance.
Seminar Objective:
- During webinar, we will make you aware about some potential risks of compliance during manufacturing of the pharmaceutical products.
- It will help in improving GMP compliance level of the organizations during lockdown restrictions.
- The webinar will trigger the process of awareness about the current state/level of GMP compliance of the organizations.
- These activities can safeguard the organizations from product failure to negative actions by the regulatory agencies.
Areas Covered in the Session :
- Risk management process as per ISO 14971
- Management responsibilities
- Qualification of personnel
- Risk management plan
- Risk management file
- Bringing it all together – links to design and process
Who Should Attend:
- Quality Assurance Departments
- Quality Control Departments
- Supply Chain Departments
- Regulatory Affairs Departments
- Manufacturing Departments
- Engineering Departments
- Operations Departments
- Production Departments
- Contract Manufacturing Organizations
- Personnel from Data Integrity Teams
- Auditors
ICT102
Section 1: Introduction and overview of Sebinar subject
Section 2: Role of 5 Ps in pharmaceutical production
– Detailed discussion on 5Ps
Section 3: Supply Chain
– Important of correct/current specifications
– Material grade
– Time of delivery
– Support in case of non-conformance
– Role of SQAM (Supplier Quality Assurance Manager)
– Kitting process benefit – Role of kitting in pharmaceuticals
– An example of vendor audit finding – Led to stopping the commercial supplies.
Section 4: Production Failures – Possibilities, failure risk, challenge the key activities to avoid failures
– Planning – Priority deciding matrix
– Control on variability – What is mean by variability? How to control, easy steps to control variability
– Lapses in line cleaning Vs Cleaning Validation
– Role of communication, ways for clear communication.
– Doer and checker principle – Why checker is required? Any alternate if checker is not available?
Section 5: Role of peoples (Personnel) a cause of possibility of error,
– Job description – Working in silos, New trends
– Weak moments – Definition, Precautions to be taken during weak moments
– Resources – Evaluation of optimum resources
– Interdependency planning
– Effect of excess resources Vs limited resources
– Correct way of identification of optimum manpower
– Training – Evaluation, effectiveness, repeat training sessions.
– Simple keys for ensuring training effectiveness
– Mental block – Reason on mental block, action plan on mental block
– Evaluation of human error as, many failures, the root cause is due to human error.
Section 6: Discussion on key issues
– Manpower,
– The weak moment of the people working in the area
– More deviations and the investigations, OOS or OOT
– Unavailability of the transportation – Impact on receipt of input materials, dispatch of the finished goods,
– More focus on current product analysis and less focus on stability sample testing
– Less support from third parties for example pest control, calibration agencies, laundries etc.
– Lack of sufficient quality oversight etc.
Section 7: Role of risk assessment in remediation of errors
– Basics of risk assessment
– Understanding the risk assessment idea in simple form
– The practical implementation
– Risk assessment of unit operations
– Avoiding wrong way of risk assessment
– Tool vs Benefit analysis
Section 7: Discussion and Q&A Session
