AAHP Compliance Thru Education Webinar ARCHIVE
It may not be possible to be fully prepared to conduct a product recall but with good preparation you and your company will survive and your reputation and your relationship with your customers will remain intact.
What the FDA Expects……
When an adverse event, product quality failure, or manufacturing mistake occurs that places consumers at risk, your company may be faced with a possible product recall. It is important to know your company’s responsibilities as well as your rights. You need to determine the reason for the recall, and the level of hazard to consumers. FDA will expect your company to be prepared to recall a product effectively and efficiently and without delay.
Are you prepared?
- Is your company prepared to perform a hazard analysis to determine the risk to consumers?
- Are you prepared to develop a recall strategy appropriate to the product, distribution pattern and level of depth for the recall?
- Are you ready with press releases and prepared statements and a spokesperson to manage customer communications and the media?
Bad things can happen to the best of companies…. Even with a company’s strong commitment to cGMPs and safe practices, product recalls can and do happen. Manufacturers today face a myriad of factors that can affect product quality and safety, so there are lots of potential places for something to go wrong. More than 2,500 product recalls occur in the United States each year, according to Dirk Gibson, an associate professor of mass communication at the University of New Mexico who has conducted extensive research on product recall practices. “Recalls are perennial. They are always out there, so it’s something we ought to plan for.”
Manufacturers must be prepared with SOPs, recall plans, training and organization to handle a product recall. Private label marketers must prepare for the possibility of needing to recall a product in concert with their contract manufacturer partners. Recalls are never easy or simple and can strain an organization and potentially ruin a good product and a good company.
A full-blown product recall is a complicated and highly regulated process, with the potential for more than just bad press — legal complications also arise when a company realizes one of its products has the potential to cause harm or injury to consumers. To get an unsafe product off the market as quickly as possible and with minimal fallout to your customers and your reputation requires preparation, preparedness and practice.
Following cGMPs and being prepared are key to reducing your company’s risk of a product recall and an valuable investment in protecting your company, your products your business and your customers.
It is critical that you are prepared.
- You will need a recall SOP with a detailed recall plan and department and individual responsibilities.
- You will need to have practiced. In order for your recall team to be effective they will need to conduct a mock recall annually. If you are a private label distributor you will need to work with your manufacturer to conduct these training exercises.
- Manufacturers, you will need to be prepared to perform a root cause analysis to determine the process failure or failures that may have led to the product failure and recall.
- You will need to investigate to determine what went wrong and how many products and batches could be affected.
- You will need to be able to track the product through the sales channel, and recall from distributors, practitioners and stores. You may have to advertise to notify consumers that they should discontinue use and return unused and partial packages. Remember 100% recall product recovery is the goal.
- You will need to have swift and effective communications with your customers and the media.
- You will need prepared messages to communicate the reason for the recall and the actions distributors, stores and consumers need to take to return the products to you.
- You will need to accomplish a through accounting for all of the recalled products.
This Webinar Covers:
- What the cGMPs require of manufacturers in the event of a recall
- What to include in SOPs for product recalls
- How to organize management, staff, distributors, contract manufacturing partners and PR in the event of a recall
- How to prepare company messages, press releases and customer letters
- About the need and value of performing mock recalls
We all hope to never have to implement such a program, yet the costs of being unprepared if the situation arises could turn an inconvenience into a crises!
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.
Meet Our Presenters:
Avril Bland of PSC Biotech, is a consultant to the food and drug industries with extensive experience in FDA cGMPs and compliance requirements within the drug industry and speaking about the requirements for SOPs, inventory management and conducting mock recalls.
Steve Edwards of Expert Recall* Stericycle will provide an overview of recall management with the extensive experience on how to streamlines the entire product recall process, manage FDA regulations, help to determine the best course of action and help to track and report recall progress.
Cynthia Batterman is the Principal and Chief Trailblazer at Essex Consulting and Vice President at AAHP. Her extensive background in management and marketing for Nelsons, ConAgra Foods and Masterfoods makes her well qualified to discuss the need for well crafted press messages for the media, industry and consumers.
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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