What's Prompting the Need for Compliance Services?
Operating under the oversight of the FDA and other regulatory agencies creates a climate of transparency for regulated companies; any misstep can result in an FDA Form-483 observation or warning letter. This, in turn, can lead to severe consequences such as product seizures, recalls, or company closure. Forming an alliance with an experienced life sciences consultant that provides regulatory compliance (e.g., crafting 483 response letters) is the first step many companies take toward restoring regulatory confidence and maintaining compliance with applicable regulations. The top reasons life sciences companies choose to hire external consulting firms are:
- Time and resource constraints: When remedial action is necessary, time is of the essence. The company cited has only 15 working days from the receipt of the 483 to respond. A regulatory compliance services provider can help identify root causes, develop corrective and preventive action plans, and mitigate associated risks quickly and effectively - without taxing the company's internal resources. The response letter is just the beginning; constant review measurements must be implemented to assure regulators of the organization's commitment to continuous quality improvement and compliance. Lack of time and adequate resources are what typically drive overwhelmed and understaffed life sciences companies to seek consulting services from external sources.
- Knowledge constraints: Some companies have adequate time and resources to devote to the remediation process but lack regulatory knowledge. A good life science consulting company, can show fledgling companies how to provide the answers the FDA seeks, and avoid a warning letter or further notifications.
- Experience constraints: Smaller companies that are unfamiliar to FDA regulators may find themselves under more scrutiny than their competitors. To level the playing field, they often hire a consulting firm, with a proven track record for providing superior regulatory compliance services, in the hope of leverage their consultant's reputation with the FDA to their advantage. In addition, external remediation consultants bring an "outsider's perspective" that resonates with management, which helps to secure buy in.
Remediation Tips from MasterControl QCC and Other Firms
- Use critical thinking: The response must be worded in a way that is acceptable to regulators. All too often companies, and even some consulting firms, respond to 483s in a casual, conversational manner, trying to explain or justify what happened. This type of response is inadequate. MasterControl Quality and Compliance (QCC) consultants use a critical thinking process to ensure that the response adequately addresses all of the issues raised by the 483 (with supporting documentation, as warranted) without making promises that cannot be fulfilled or committing to unrealistic deadlines. If the company or its consultant over promises and under delivers, there is a good chance they'll receive a second write up for the same violation, which almost guarantees a warning letter.
- Be transparent and comprehensive: 483 responses must be completely transparent and comprehensive, and address not only the observation itself, but also the broader issues implicated by the observation. Life science consulting firms that are experienced in providing regulatory compliance services understand that regulators are not interested in a justification of "why" a particular nonconformance may have occurred. They want to know "what" corrective actions the 483 recipient intends to take to remedy the situation - and "when." It's important to explain each aspect of the resolution carefully to demonstrate the company's commitment to prevent reoccurrence. The company cited, or its consulting partner, must convince investigators that they are remedying the problem to satisfy not only safety and compliance issues, but also because it will make their business better.
- Follow up is critical: Many companies panic when they receive a 483, but forget about it once the response letter is out the door. Follow up is paramount to successful remediation. After the response letter has been sent, the 483 recipient should perform a mock audit to prepare for the FDA's return. Hiring a qualified life science consulting firm to conduct a gap analysis can also be helpful. Remember, 483s are often a symptom of a much larger issue. It's important for the company cited to dig deep, uncover the root cause of the problem, and show the FDA that are doing more than the minimum required. If a company lacks either the time or expertise to address the 483 in the level of detail described, it should consider hiring a regulatory compliance services partner.
What Makes MasterControl QCC Different From Other Life Science Consulting Firms
MasterControl QCC stands apart from other consulting firms because of its vast industry knowledge and experience. QCC consultants, many of whom are former FDA auditors, use a process approach and proven methodologies that enable them to provide expertise, resources, and sound project management throughout all phases of the remediation process. QCC also offers training workshops that teach participants how to implement and follow a best practice system for handling 483s and other regulatory citations. Regulatory compliance services are just a fraction of what QCC offers to regulated companies worldwide. Additional services are offered in supply chain management, validation/qualification, quality process training, certification/accreditation assistance, new product acceptance, and quality management systems. Regulatory remediation is a long and tedious process. If a company hires a life science consulting firm that doesn't understand their business, as well as FDA regulations, it will waste valuable time, energy, and money creating and following a remediation plan that isn't right for them.
For More Information on MasterControl's Life Science Consulting Services
For more information about MasterControl QCC's life science consulting offerings, including regulatory compliance services, contact us today.