Educational Webinar Resources Available

FDA’S VIEW ON COMPLIANCE — IN THEIR OWN WORDS

This webinar gives industry members a chance to hear directly from Mr. Brad Pace, the Acting Director of the Division of Nonprescription Drugs and Health Fraud within FDA’s Center for Drug Evaluation and Research (CDER), Office of Compliance. The one-hour webinar provided a very beneficial insight into the Agency’s present thinking and direction. If you missed the live webinar, you can still purchase a DVD with the entire webinar, plus all handouts presented during the event.

$279 / Members $189. (Plus $10 S&H). Available by order direct from the AAHP office (checks only, please).

AAHP webinars can help fulfill your required mandatory staff training requirements. Homeopathic manufacturers and marketers have found AAHP to be an excellent third-party source for this training.

 

2016 HPUS UPDATES WEBINAR FOCUSING ON PRODUCT LABELING

Eric Foxman presented a one-hour webinar on the new Expanded Labeling Guidelines for Homeopathic Drugs now published in the Homeopathic Pharmacopoeia of the United States (HPUS). This expanded labeling guidance addresses all facets of homeopathic labeling for single and combination products. The goal of this guidance document is to ensure that consumers and practitioners are able to clearly determine the active ingredients, the homeopathic attenuation and the amount of an ingredient included in the product. (DVD includes handouts.)

$199 / Members $109. (Plus $10 S&H). Available by order direct from the AAHP office (checks only, please).

 

HPUS UPDATES 2014 CHANGES THAT MAY AFFECT EVERYONE

Eric Foxman, Mary Beth Watkins, (Nutraceuticals Corp.) and Eric Baier (SHC) presented a 1.5-hour webinar with a concise overview of important information contained in a number of new guideline documents, and the implementation schedule for the guideline documents. This webinar focused on the Homeopathic Drug Stability Guidelines as well as background on the Revised Homeopathic Labeling Guideline Document. Don’t be fooled into thinking the content is dated. The information is still current and of immeasurable importance in your company’s compliance efforts. Whether you are a manufacturer or marketer, the labeling information and stability guidelines affect every company involved with homeopathic drug products. (DVD includes handouts.)

$279 / Members $179. (Plus $10 S&H). Available by order direct from the AAHP office (checks only, please).

 

HOMEOPATHIC PHARMACOPEIA UPDATES 2013 WHAT CHANGES MIGHT AFFECT YOUR BUSINESS?

Jay Borneman and Eric Foxman presented a one-hour webinar detailing the HPUS as a continually updated and expanding guide for the manufacture and quality of homeopathic medicines. The HPUS, as an official compendium recognized by the FDA, is critical to every manufacturer, formulator and contract marketer. As the FDA continues to broaden its focus on the homeopathic industry, it is important to stay informed as changes in the HPUS are made. The updates covered in this 2013 session are still in effect and need to be known by manufacturers and marketers of homeopathic medicines. This short, efficient web-seminar will help you to stay on top of these changing guidelines as it relates to your regulatory compliance. (DVD includes handouts.)

$139 / Members $89. (Plus $10 S&H). Available by order direct from the AAHP office (checks only, please).

 

PREPARING FOR AND MANAGING PRODUCT RECALLS

Avril Bland (PSC Biotech), Steve Edwards (Stericycle) and Cynthia Batterman (Essex Consulting) presented a 2.5-hour webinar detailing a full-blown product recall as 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. Getting 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. (DVD includes handouts.)

$395 / Members $195. (Plus $10 S&H). Available by order direct from the AAHP office (checks only, please).

 

FDA CURRENT HOT TOPICS CGMP COMPLIANCE

Rachel Roerhig (CHPA), Eric Foxman, and Kevin Carrasco, (Speed Laboratory) presented a 2.5-hour webinar on cGMP compliance addressing the regulations for conformance management of components, raw materials and labeling for homeopathic drug products. This presentation covers ensuring product quality with the establishment of material and component specifications; confirming raw materials with required identity testing, and other FDA ‘hot button’ inspection issues. Take advantage of lessons learned to avoid a warning letter or 483 observations for the management of components and raw materials. This cGMP compliance is critical for private label marketers and their contract manufacturers along with all other manufacturing facilities.

$349 / Members $249. (Plus $10 S&H). Available by order direct from the AAHP office (checks only, please).

 

MANAGING CONTRACT MANUFACTURING RESPONSIBILITIES & RELATIONSHIPS

Cathy Raish, Robert Cohanim, and Travis Borchardt presented a 2.5-hour webinar on how to mange manufacturing arrangements and ensure the quality of products. Even if your company does not currently participate in a contract manufacturing agreement, the valuable information on setting specifications, testing to confirm compliance to specifications and quality management apply to all drug manufacturers. Managing contract manufacturing relationships requires that both parties, the contract manufacturer and the contract marketer: meet their regulatory compliance obligations; communicate frequently, effectively and honestly; comply with cGMPs; and work well together with mutual trust and respect. Contract manufacturing agreements can assist in managing responsibilities and liability for both parties. When one partner in the contract agreement fails to meet any of these requirements they place both companies, their other customers, and all end product consumers at risk. (DVD includes handouts.)

$395 / Members $195. (Plus $10 S&H). Available by order direct from the AAHP office (checks only, please).

 

MANAGING CONSUMER CALLS COMPLAINTS, CGMP COMPLIANCE, QUALITY AND SERVICE

Alvin J. Lorman, Mary Beth Watkins, and Walt Murray (MasterControl) presented a two-hour webinar on 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 standard operating procedures 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. In addition, 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.

$395 / Members $195. (Plus $10 S&H). Available by order direct from the AAHP office (checks only, please).

 

FROM LEAF TO LABEL MANAGING FOR QUALITY

Janeen Skutnik (partner at NSF), Pejman Parhami (SHC) and Steve Mann (Nelson Bach) presented a 2.5-hour webinar on vender qualification and the confirmation through testing of materials, components and finished products. These steps are essential and critical for manufacturers, marketers and contract labelers alike. The FDA frequently cites companies for failure to qualify suppliers, set specifications for materials and components and for not testing and evaluating materials and products to ensure they meet specifications.

$349 / Members $249. (Plus $10 S&H). Available by order direct from the AAHP office (checks only, please).

 

BEST BRANDING PRACTICES

Bob McNabb (Natural Marketing Institute), Cynthia Batterman (Essex Consulting), Chip Weinstein (Brand Digital) and Danielle Conte (Vertical Marketing Network) presented a 2.5-hour webinar covering the latest information on what drives consumer trends and what consumers are saying about homeopathic products; defining and differentiating your brand; creating clear, consistent and motivating brand messages; how to build a brand on any budget, and many other topics. This informative webinar provides a wealth of information in an easy to manage format.

$349 / Members $249. (Plus $10 S&H). Available by order direct from the AAHP office (checks only, please).

 

Combined order? 2 DVDs = $15 S&H; 3 or more DVDs = $20 S&H.

Make checks payable to:

American Association of Homeopathic Pharmacists

4332 SE Logus Road • Milwaukie, OR 97222

(Sorry, no credit cards.)