Educational Webinar Resources Available

Missed an education opportunity?

Need materials for your mandated employee training?

You have a second chance!


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.

 

All DVD’s include an MP4 recording of the webinar, an MP3 audio-only recording, a copy of the presentation material, and any supplemental documents that accompanied the webinar as additional valuable resource materials.


Save on a 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.)

COMPLIANCE + CGMP TOPICS


FDA’S VIEW ON COMPLIANCE — IN THEIR OWN WORDS

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 presented an overview on the Agency’s concerns about compliance of homeopathic drug products. What Mr. Pace didn’t say was as enlightening as what he did present. The one-hour webinar provided a very beneficial insight into the Agency’s present thinking and direction.

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


FDA INSPECTIONS OF HOMEOPATHIC MANUFACTURING FACILITIES - AN AGENCY VIEW

Tamara Ely, Senior Policy Advisor in the Office of of Manufacturing Quality in FDA’s Center for Drug Evaluation and Research (CDER - FDA) examined FDA’s considerations for inspections regarding compliance in homeopathic drug manufacturing facilities. Ms. Ely’s presentation included case studies and examples of compliance outcomes.  In this 90 minute webinar , she brought a clear overview of what to expect from an FDA inspection of a homeopathic drug manufacturing facility.  By knowing what the Agency takes into consideration, you can better prepare for inspections and minimize their impact on your day to day business activities.

Price: $299 / Members $209. (Plus $10 S&H). Available by order direct from the AAHP office (checks only, please).


RECALLS: FDA EXPECTATIONS & HOW YOU CAN BE READY

Ryan Gooley (Stericycle) provided an overview of recent recall trends, including Top recall causes and leading recall categories.  In this 1 hour webinar, he provided in-depth guidance to what information FDA is looking for in the event of a recall, and covered what your organization can do to be ready should a potential recall arise.

Price: $239 / Members $149. (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, componants and finished products. TYhese 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.

Price: $349 / Members $249. (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.

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


HERE COMES THE FDA – BE PREPARED

George Bernstein (MAI Consultants) shared his views on recent events in FDA enforcement actions. With his unique perspective as an independent consultant who has worked with a number of homeopathic companies. George is attentive to each and every warning letter and FDA action that could affect the industry. During this 90 minuite webinar, George offered insights and helpful hints to prevent inspection problems before they arise as well as concrete steps to be taken after any inspection proceeding. George brought years of experience from his active involvement with inspection and Warning Letter remediation for homeopathic companies and allopathic manufacturers in the US, Europe, and Asia.

Price: Special Pricing was made for this webinar: $75 / Members $25. (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.

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


PHARMACOVIGILANCE FOR SAFETY AND COMPLIANCE

Steve Swantek (Propharma Group) outlined the essential foundation each company must undertake to ensure safety of their products and compliance with pharmacovigilance requirements. Pharmacovigilance is more than just complete and accurate case information and the timely submission report required by regulation.

What infrastructure must be in place to address documentation, coding, assessment, and signal detection?  How can the intake and documentation of product complaints aid or hinder your quality investigation? What portion must be performed in-house? What pharmacovigilance services can be provided by an outside vendor?

Price: $239 / Members $149. (Plus $10 S&H). Available by order direct from the AAHP office (checks only, please).


STABILITY STUDIES FOR HOMEOPATHIC PRODUCTS

In this two part webinar, Pejman Parhami and Aryo Nikopour outlined essential information that places stability studies within a larger context of product quality, and not just a required task to establish expiration dating. Products lacking adequate stability are not assets for your company; rather they represent liabilities. At the same time, warehousing of products with inadequate stability information represents a hidden cost which could be better utilized by your company in increased sales and profits.  Pejman and Aryo provided insights into how stability findings can create products with competitive advantages.

Price: Special pricing for the 2 part webinar: $299 / Members $179. (Plus $10 S&H). Available by order direct from the AAHP office (checks only, please).


DOCUMENT CONTROL –

Mark Vermette and Lyn Agostinelli (Halloran Consulting Group) presented the processes and procedures of document control from a quality systems perspective.  Based on their their decades of experience, they brought a concrete perspective, based on real world insights, on what the FDA expects to see during an inspection of your facility.  During this 1 hour webinar Mark and Lynn covered Quality Management Systems, (including Quality manual, Policies and procedures, and SOPs), roadmaps for document development, approval, and maintenance, and how to prepare for an FDA inspection.

Price: $239 / Members $149. (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.)

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

REGULATORY


E.U. AND U.S.A. REGULATIONS

Whether your company is located in the U.S. or the E.U., you need to be aware of regulations on “the other” side of the ocean in today’s global market. This is especially true for homeopathic drugs; the starting materials for many of which are available only from one continent or the other.

Steve Mann and Eric Foxman \provide insights on how regulations within a supplier’s country impact your ability to import those starting materials. At the same time, they discuss the ramifications of the end marketer’s national requirements on the export of homeopathic starting materials.

Price: $239 / Members $149. (Plus $10 S&H). Available by order direct from the AAHP office (checks only, please).


HPUS UPDATES 2018-2019

Eric Foxman reviewed the rationale for changes in the listed first safe attenuations and presented background on how the HPCUS determines these first safe dilutions.  He also provided new required HPUS warning language wording for selected monographed substances.  All manufacturers and marketers of homeopathic drug products need to be aware of these new guidelines to their ensure their products and labeling do not fall into the high risk categories identified by the FDA for enforcement action.

Price: $179 / Members $89. (Plus $10 S&H). Available by order direct from the AAHP office (checks only, please).


2017/18 HPUS UPDATES --  COMPENDIAL DEFINITIONS AND HOMEOPATHIC GMPS CHANGES

In this 1 hour webinar, Eric Foxman covered the changes in HPCUS definitions affecting the OTC / Rx and External Use Attenuations. Updates are also being made to attenuation levels for selected monographs, as well as the HPCUS Good Manufacturing Practices Guidelines which incorporate information from recent FDA documents. These changes and updates can affect your business, your cGMP compliance, your products and your long-term success in the market!

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


HPUS UPDATES 2017  - Homeopathic GMPs and Stability

Eric Foxman presented the revised Homeopathic Good Manufacturing Practices and the new Homeopathic Drug Stability Guidelines in the Homeopathic Pharmacopoeia, HPUS. These two documents address issues that stand behind your homeopathic products on retail shelves – issues regulators expect you to comply with and your consumers demand you adhere to. These guidance documents ensure the products you bring to market meet reasonable and appropriate expectations for homeopathic drug products while assuring a consistent level of quality.

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


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.)

Price: $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.)

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


HPUS 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.)

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

MARKETING & CONSUMER AWARENESS


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.

Price: $395 / Members $195. (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.

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


HOMEOPATHIC DRUGS - CONSUMER TRENDS AND INSIGHTS

The market for homeopathic and herbal remedies continues to grow. Due to increased healthcare costs and insurance issues, more consumers are proactive about their health and wellness. This, paired with the fact that consumers are using more organic and natural products, helps fuel the growth homeopathic remedies as consumers look for what they perceive to be as safer alternatives.

Mintel, the leader in consumer research, presented information on the homeopathic drug market based on their broad and deep reach into the research on consumer choices and trends.  Mintel’s Health and Wellness Analyst, Emily Krol, presented key findings and insights gleaned from their extensive 40 page 2013 report, Homeopathic and Herbal Remedies, Issues in the Market. Emily will also draw upon Mintel’s 2011 report for a longer range overview of emerging trends.  These insights will make understanding the most recent Mintel reports even more beneficial for it’s readers.

Price: $179 / Members $89. (Plus $10 S&H). Available by order direct from the AAHP office (checks only, please).


MARKET ANALYTICAL TOOLS FOR UNDERSTANDING AND GROWTH

In this focused webinar, Steve Kim (of I.R.I.) provided an overview of the core capabilities for competitive advantage. Using predictive analytics, one can explore the implications of price elasticity. The webinar helps companies understand what industry sections of have the largest dollar and growth volume rates? What are the shopping habits of the homeopathic consumer? This goes beyond the data to help companies gain useful consumer insights that can propel their businesses forward.

Price: $189 / Members $99. (Plus $10 S&H). Available by order direct from the AAHP office (checks only, please).