Pharmaceutical Manufacturer Compliance Team Lead – Timothy E. Allen | Former Special Agent (U.S. Secret Service & DOJ-OIG)
Every process and product has associated risks. While it’s impossible for pharmaceutical manufacturers to eliminate risk completely, it’s possible to minimize it considerably by introducing quality controls and other risk mitigation tools in the manufacturing process. In a pharmaceutical manufacturing setting, risk management does many things, from ensuring consistent product quality throughout a product’s life cycle to avoiding legal and compliance problems.
Risk Management Today
Initially, risk management processes were dominated by trend reviews, checklists, observations compilation, flow charts, and change reviews. Today, the risk management approach is led by regulatory agencies and involves the use of statistical tools. Risk management has also become a systematic process characterized by assessing, controlling, communicating, and reviewing risks.
Our Approach
Corporate Investigation Consulting begins by identifying possible risks associated with the products a pharmaceutical manufacturing company produces and the process used in developing, manufacturing, and distributing products.
Our risk management consulting approach guarantees the production of high-quality medication. It also ensures pharmaceutical manufacturers make better decisions. We utilize systematic processes to facilitate, co-ordinate and improve decision-making associated with different risks. Our approach is scientific-based with reliance on the best risk management processes.
Put our highly experienced team on your side
Roger Bach
Former Special Agent (OIG)
Timothy E. Allen
Former Senior Special Agent U.S. Secret Service
Chris J. Quick
Former Special Agent (FBI & IRS-CI)
Maura Kelley
Former Special Agent (FBI)
Ray Yuen
Former Supervisory Special Agent (FBI)
Michael S. Koslow
Former Supervisory Special Agent (DOD-OIG)
Marquis D. Pickett
Special Agent U.S. Secret Service (ret.)
How We Identify and Deal with Risk in Pharmaceutical Manufacturing Facilities
We use methods that identify risk capable of compromising the quality, safety, durability, and efficiency of drugs and the process of making drugs. After identifying risk, we evaluate and plan effective responses.
Corporate Investigation Consulting identifies risk, evaluates according to priority and severity before facilitating subsequent action. We use hazard analysis, among other risk management techniques.
Our risk management consulting services include determining the impact of risks. We can tell the areas or product attributes likely to be affected by specific risks or probable problems in the manufacturing process and establish criteria for evaluating the impact of potential risks/problems.
Risk Management Methods in the Pharmaceutical Manufacturing Industry
Drug companies after risk management consulting services can either undergo qualitative or quantitative risk analysis.
Qualitative risk analysis utilizes subjective information to establish a conclusion without a statistical outcome. Our qualitative risk analysis enables informed decision making on non-quantifiable information.
Quantitative risk analysis is based on statistical analysis to establish the precise level of risk in a process, system, or facility. This analysis combines probability, severity, and delectability.
Our risk management consultants are well versed in both methods and many others. They’ll assess risk and assign specific values in the risk priority scale to offer accurate estimates of identified risks.
Risk Management Checklist and Risk Management Plans
Corporate Investigation Consulting can prepare checklists for use in pharmaceutical manufacturing processes. Our checklists ensure all risk management procedures are identified and followed to the letter during all processes that pose a risk.
We’ll also establish a risk response plan highlighting effective reactions to specific risks/problems. Our risk response plans include responses such as changing products, processes, or programs, pursuing risk mitigation measures, or ways of avoiding risk.
The plans also ensure best industry practices and put pharmaceutical manufacturing facilities in line with regulators like the FDA that recognize the importance of organizing processes and procedures through risk management. Our risk management consulting services meet every compliance guideline by regulators in the U.S.
The FDA’s Take on Risk Management for Pharmaceutical Manufacturers
The FDA treats risk management as a deliberate safety program for decreasing product risk through various interventions or tools. According to the FDA, pharmaceutical manufacturers should consider how they can minimize risks arising from the use of their products. Considerations should encompass everything from special studies to product labeling and pharmacovigilance.
As per the FDA, the risk management process should start with studying and interpreting the risks and benefits of a product. This process should be followed by establishing and implementing risk management interventions that minimize product risk, after which the interventions should be evaluated and revised if need be.
Corporate Investigation Consulting risk management experts understand the FDA’s guidelines on pharmaceutical manufacturing to the letter. We can also assist on compliance with other regulatory guidelines. Talk to us now 866-352-9324.
Documenting and Communicating Risk
All stakeholders should be involved in the risk management process from the initial data collection stages to the decision-making stage aimed at controlling risk. Communicating risk is critical for ensuring commitment and support from all stakeholders.
The results of a risk management consulting process that includes risk analysis, risk assessment, recommendations, etc., must be documented and communicated to all stakeholders.
Corporate Investigation Consulting documents every aspect of the risk management process. Our documentation lists all perceived risks and tracking mechanisms of those risks. We also include summaries on risk mitigation. Our documentation offers clear references.
Training and Education
Our risk management consulting services include training of relevant pharmaceutical manufacturing personnel on risk management principles and applications. Pharmaceutical manufacturing staff should understand risk management, understand the skills needed to mitigate risk, and have access to resources enabling effective risk management principles.
When developing risk management programs, we establish working instructions and processes that clarify strategy and define every staff’s tasks clearly. Risk management training is important for enhancing awareness. Pharmaceutical manufacturing staff responsible for handling different aspects of risk from managing to reviewing must get formal training in the procedures in question.
Our risk management consulting service also involves cooperation between manufacturers, responsible authorities, and other stakeholders. We can facilitate joint training between pharmaceutical manufacturing staff and medicines regulatory authorities to foster and maintain continuous dialogue and establish an in-depth understanding of risk management.
Risk management consulting for pharmaceutical manufacturers involves assessing every possible origin of risk. We assess processes, materials, facilities, staff, distribution, and more. We also address other factors such as training since the success of risk management efforts is largely dependent on the staff and management understanding the significance of risk management in the production of safe pharmaceuticals.
Contact Corporate Investigation Consulting for risk management consulting services that allow well-informed decision-making processes. Our services are bound to reduce the risks faced your pharmaceutical manufacturing company.
Request a free-confidential risk management consultation now to support your pharmaceutical company’s goals. Poor risk management can attract unprecedented actions ranging from legal liability to closure of your facility. Choose experts with nationwide risk management expertise. Call us at 866-352-9324 or reach out online today.