AAHP Compliance Thru Education Webinar ARCHIVE
Customers are one of the most valuable assets of any company, even though they do not typically show up on a company ledger sheet or on a list of company assets. Customers are why we are in business and meeting their needs and providing great service is important to our businesses. Customer calls are an important touch point for every company and need to be managed to insure customer satisfaction and safety.
Customer calls and complaints have been mentioned in a number of recent FDA warning letters as the Agency continues to stringently enforce cGMPs during inspections. Case in point, Novartis Consumer Health Inc. is one of the more prominent reminders of the importance of investigating consumer complaints.
In 2010 Novartis was cited for inadequate investigation of consumer complaints, some including adverse events related to an uncharacteristic odor. The complaints were received over a period of more than 2 years, and numbered well over 100 in the first six months alone. Initial investigations failed to determine the cause of the odor and the investigation was dropped only to have the same complaints the following year. Again, an investigation was undertaken with no clear cause or findings and again dropped by Novartis.
The FDA sited the lack of adequate quality review and investigation and the failure to reach a root cause for the complaints. The FDA detailed the need for improved SOPs, improvement in QC management and training, performing adequate investigations of consumer complaints and initiation of corrective actions in response to consumer calls along with an investment by Novartis of $150 million to upgrade manufacturing and quality at their manufacturing sites.
Ignoring and not investigating consumer complaints can be a costly oversight. Your customers deserve to have their questions and complaints investigated and to receive clear reassurances that your systems are under control and your products meet their quality and safety expectations.
Manufacturers and private label marketers of drug products must be prepared with procedures to receive and manage consumer calls and complaints, investigate complaints for their root cause, and create and implement corrective actions to prevent recurrences. Companies need to have SOPs and personnel training in place, along with a process for documenting each call, each investigation, any findings and all corrective actions. Determining when a customer call may be more than a complaint and is a potential adverse event is essential for consumer safety and compliance.
Private label marketers must be prepared to work with their contract manufacturing partners to investigate consumer complaints and to determine the necessary corrective actions. Contract manufacturers are responsible for performing the necessary investigation to determining the possible cause of a consumer complaint and documenting the investigation and any corrective actions and retraining necessary.
Note: this webinar can also be utilized by your staff in fulfillment of your required mandatory training requirements. Homeopathic manufacturers and marketers have found the AAHP to be an excellent third party source for this training.
This Webinar Covers:
- What the cGMP requirements are for marketers and manufacturers of drug products in managing consumer complaints;
- How to conduct a thorough investigation of the complaint;
- Importance and tools for investigating consumer complaints;
- The requirements and value of performing corrective actions.
About Our Presenters
Alvin J. Lorman, Esq. is currently the attorney for the AAHP and has been for over 25 years representing the interests of homeopathic drug manufacturers and marketers with the FDA and legislators. He also served as associate general counsel of the CHPA. Al has over 30 years of practice with large national and international law firms and practices in all areas of food and drug law, biotechnology and health law, trade association law, and advertising law. He lead the industry effort which resulted in the publication of FDA’s Compliance Policy Guide on homeopathy, a policy which has lead to a dramatic increase in the availability of homeopathic products. Al introduces the issues surrounding the management of consumer calls and complaints and their importance to your business. His experience and insights are of special value given his experience and expertise working with the issues and our homeopathic industry.
Mary Beth Watkins, MS, BS, is the Director of Quality and Compliance for Nutraceutical Corporation Homeopathic products, with over 25 years in quality management experience in formulation, manufacturing, quality, labeling and cGMP compliance of homeopathic drugs, OTC drugs, dietary supplements and herbal products. Mary Beth has experience in working with the FDA and Federal Code of Regulations for compliance, inspections, documentation, laboratory and department management and quality testing. Mary Beth speakes about the details of ‘things gone wrong’ that could have been prevented with a proper system in place.
Walt Murray of MasterControl is currently the Director of Quality & Compliance Consulting Services. He is a QMS Certified Lead Auditor and has over 30 years of experience in operational responsibilities for quality in manufacturing and regulatory oversight and provides assistance to clients and life science companies in need of guidance and development. Walt provides a in-depth look at systems for handling complaints from initial incoming contact thru investigation follow-thru. MasterControl provides software solutions that enable regulated companies to get their products to market faster, while reducing Cost of Quality (COQ) and increasing internal efficiency. MasterControl provides secure management solutions for a company’s critical quality information throughout the entire product lifecycle. MasterControl solutions include quality event management (QEM), document management, product lifecycle management (risk management), audit management, training management, document control, bill of materials, supplier management and much more.
This 2.5 hour Webinar DVD also contains all the handouts available during the original on-line event.
Webinar DVD archives can be ordered directly from the AAHP office at 4332 SE Logus Road, Milwaukie, OR 97222. The cost of the DVD Archive is $395 (includes S&H); AAHP members get a $200 discount.
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