The Most Important Compliance Best Practices You Need to Know

In recent years, cosmetics companies have been increasingly pulled up by the FDA for failing to follow regulations, especially those governing manufacturing and branding of products.Companies big and large have been sent Warning Letters for making scientifically unproven claims, adulterating their products, microbial contamination at manufacturing facilities and more.This White Paper puts together five best practices that can help cosmetics manufacturers address these issues and others in order to avoid regulatory enforcement actions and worse.

The explosion in use of social media over the past few years has been both a blessing and a curse for life sciences companies and consumers who use their products. While platforms such as Facebook and Twitter might present a great opportunity for marketing products, the limitations of the tools can present regulatory pitfalls for companies and dangers to consumers. The rapid pace of technological progress has caught agencies such as the FDA and FTC on the wrong foot and they have struggled to formulate and implement regulations on social media use. It is clear though that the onus for compliance lies with regulated companies. However, the overlap between regulations for conventional marketing and promotion and social media guidelines that are still evolving has led to confusion about compliance requirements. This white paper discusses 5 ways in which drug and device companies can stay on the right side of the regulatory agencies and ensure that they don’t attract penalties for violations.

When the FDA inspector calls, even the most experienced professional can lose confidence and make the inspection process more painful and confrontational than it needs to be. Firms are very often unsure of how to deal with the FDA inspector’s requests and can complicate matters by becoming too antagonistic or go in the opposite direction and volunteer more information than necessary. This white paper discusses different types of FDA inspections and the seven best practices that FDA regulated companies can follow in order to ensure a trouble-free FDA inspection process that reduces the risk of multiple and unnecessary Form 483 observations.

A recent study showed that US consumers spent USD 23 billion on OTC drugs in 2010. The huge market for these drugs spurs companies to create and launch more products. The market growth has, however, also forced the FDA to crack the whip on regulatory violations. While a number of manufacturers of OTC drugs are warned for CGMP violations, many also face enforcement action for shoddy labeling and branding. Considering that consumer trust is vital for the sales of an OTC drug, news that a manufacturer has been fined or warned for mislabeling can lead to a significant drop in consumer confidence, affecting the company bottom line. This White Paper explains six best practices that manufacturers can follow to ensure that they comply with the FDA’s stringent OTC drug and drug-cosmetic labeling regulations.

Drug Enforcement Administration (DEA) audits are primarily carried out to ensure that there is no diversion or misuse of controlled substances.The audits also help to educate registrants in case of any identified discrepancies.This white paper addresses compliance issues relating to DEA audits, provides assistance to registrants to ensure strict compliance and the right adoption of drug ordering practices. It also details the correct ways to interact with inspectors during a DEA audit.

Documentation - specifically recordkeeping - and proper communication are two cornerstones of the OSHA compliance process that all employers have to follow in order to maintain a safe workplace for their employees. This white paper discusses why proper documentation and communication practices are necessary for employers to avoid unnecessary penalties and the ways in which they can ensure OSHA compliance.

The global nature of international trade – facilitated by the implementation of agreements such as NAFTA – has created a confusing array of regulatory compliance procedures that most businesses haven’t fully understood. Requirements such as Country of Origin Marking and HTS Classification are crucial to achieve Customs compliance in the US and avoid hindrances for businesses. This White Paper discusses the best practices that importers and any company or individual dealing with international trade must follow in order to achieve Customs compliance and avoid heavy fines or seizure of goods.

An audit of Human Resource practices can reveal the department’s success or failure in performing and executing its roles, level of compliance with existing, applicable regulations,alignment of practices with organization’s strategies and goals and areas for improvement. This white paper examines current trends in HR auditing across the industry and details the five key areas that must be audited in order improve compliance with existing, applicable labor regulations.

Compliance with the principles of GLP (Good Laboratory Practices) is a legal requirement for test facilities. After each GLP study is completed or terminated, a GLP final report must be prepared for submission to the regulatory agency. Test facilities should follow GLP guidelines and good archival practices as non-compliance compromises the quality and integrity of the study and gives scope for rejections,warning letters and citations by the FDA. This white paper primarily intends to provide information about necessary documentation, requirements for GLP final reports, and also details about best practices to be followed in final reporting and archiving for regulatory compliance.

The EU regulates medical devices with the EU Medical Device Directives. The core concern of these devices is safety of the end user and the regulations have been formulated keeping this in mind. The complexity of the EU, a body with 27 member states,necessitates unique regulatory requirements that device importers or foreign manufacturers have to be aware of in order to achieve compliance. This white paper discusses six key elements that will help manufacturers ensure compliance with the EU Directives and avoid the unnecessary costs and confusion that can result due to misunderstanding the regulatory processes.

The dietary supplement market has witnessed huge growth in the last decade and this boom in sales been accompanied by increased regulatory scrutiny. Both the government and federal agencies are concerned about the dangers posed to public health by misleading claims and labels on these products. The FDA is cracking down on the health claims being put forward by dietary supplement makers about their products. The agency is planning to widen its surveillance of the market to detect such claims.This white paper details how dietary supplements are currently regulated and six labeling best practices that dietary supplement manufacturer should follow in order to ensure compliance.

Clinical trials that fail to achieve their goals are often the result of poor budgetary planning and decisions.Given the various processes, individuals and committees involved in a clinical trial, budgeting can be a tricky process. A proper clinical budget is one that not just factors in the obvious costs, but also anticipates hidden ones and provides for unexpected situations or contingencies. This white paper explains why budgeting for a clinical trial is important, the various phases in clinical research and the budget related activities in each, the different kinds of clinical costs and five best practices that organizations should follow when creating and implementing a clinical study budget.

As the market for medical devices in China grows, the country is increasing its regulatory scrutiny of products being sold to consumers. The regulations governing device registration, marketing,safety and vigilance are especially strict and manufacturers can land into the legal hot water if they don’t comply with the law. This white paper discusses six best practices (registration,marketing authorization, instructions for use, labeling, device advertising rules, device safety) that are vital for manufacturers to ensure they are in compliance with medical device registration, marketing and safety rules in China.

21 CFR Part 11 specifies requirements for handling electronic records and electronic signatures and applies to any records covered by FDA regulations that exist in an electronic form. The main objective behind implementing this regulation was to prevent fraud while facilitating, promoting the possible use of electronic technology to reduce expenditures incurred from paper sources.This white paper provides an overview of FDA requirements for electronic systems and the applicability of 21 CFR Part 11. It also details consequences for non-compliance and six key aspects FDA regulated firms should focus on so as to ensure compliance.

Companies in the financial services domain have been tentative about using social media to promote and market their products and services. Uncertainty about which regulation would apply to this relatively new communication phenomenon and horror stories of license suspension or hefty fines for non compliance have scared off even the most well known firms in finance.However, with the recent release of guidance notices from FINRA and communications from the SEC, the regulatory requirements have become clearer. This white paper discusses five best practices that financial services firms should implement to ensure compliance with the current regulatory requirements, including how to supervise, whether recordkeeping is necessary and what should be done about third party content.

Avoid EEOC enforcement actions and legal penalties by ensuring that the HR department has a robust process to handle workplace sexual harassment complaints.In FY 2012, the Equal Employment Opportunity Commission (EEOC) received 7,571 claims of sexual harassment in the workplace. Of these, 977 or 10.9% were settled. The benefits paid out to claimants amounted to USD 43 million (these do not include the benefits obtained through litigation).The numbers alone show that workplace sexual harassment is a challenge that HR departments have to work hard to prevent and if complaints are made, need to be managed with tact and professionalism. This white paper details five best practices that HR departments can adopt in order to ensure they are compliant with the prevailing laws against sexual harassment in the workplace.

Inadequate design controls continue to be highlighted by the FDA as a major reason for warning letters issued to medical device companies. Manufacturers who have lax controls over design and development of devices also have to recall products as they may endanger user safety. Such actions have a negative impact not just on company profit margins, but also reputation and public trust. This white paper discusses six best practices that medical device manufacturers should follow in order to devise and implement design controls that are compliant, adequate and help in making products that are safe and effective.

The FDA strictly regulates the import of medical devices into the United States. It has detailed regulatory requirements for foreign medical device manufacturers that should be followed if imported devices are to be sold in the US market. Non-compliance with these rules can result in detention of products at ports of entry, unnecessary expenses involved in paperwork, queries and hearing and a loss of revenue for the importer. This white paper provides five best practices that both foreign medical device manufacturers and importers in the US can follow in order to ensure that the device import process is quick and efficient.

Avoid FDA warning letters for combination product non-compliance by adopting current best practices Confusion still exists among manufacturers as to what regulations cover research and development and marketing as well as FDA approval of combination products. The agency has only recently finalized its Current Good Manufacturing Practices (CGMP) for combination products. This white paper explains the current regulatory environment relating to combination products and five best practices manufacturers should follow in order to achieve FDA compliance and approval.

The uncertain environment in which businesses operate today - constantly changing regulations,expanding global footprints, volatile market conditions, unpredictable socio-economic upheavals as well as natural disasters - has made it increasingly necessary for organizations to ensure they have a robust and effective system to manage operational risks. These risks cannot be discounted by the modern, international organization - the cost of ignoring them can be catastrophic in terms of reputational and financial damage. This white paper details five best practices that organizations can adopt in order to manage operational risks more effectively.