The American Association for Homeopathic Products

Managing Consumer Calls: Complaints, cGMP Compliance, Quality and Service Webinar Archive
2015-01-10 - 2018-01-09 | Webinar Archive
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.
Click here to order

From Leaf to Label - Quality Throughout the Cycle -- Webinar Archive
2015-01-09 - 2018-01-08 | Webinar Archive
AAHP Compliance Thru Education Webinar ARCHIVE
Anyone who makes a habit of reading FDA warning letters will have noticed the unmistakable trend in the increased FDA scrutiny of cGMPs throughout the product life cycle. This scrutiny runs from ingredients and components to finished products. This AAHP seminar will highlight key compliance steps from starting materials and components, through manufacturing processes and the specifications, evaluation and testing of finished products.
Vender qualification and the confirmation through testing of materials, components and finished products are 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.
Ensuring quality means all the internal systems are in place to verify that quality is built into processes and products through the entire manufacturing cycle — from ’leaf to label’. Starting materials, excipients, and components must all have written specifications and be inspected, sampled, tested and evaluated to determine if they are suitable for use in the manufacture of homeopathic products
The FDA has steadily increased the number of Agency inspections and warning letters over recent years. In 2010 the trend peaked at 189 warning letters to drug firms or about one every 6 days. This was an increase of 320% over the number of 2008 warning letters. In 2012 the number of warning letters had declined to 73 still almost a 50% increase over 2008 levels. And it is not just the number of inspections, but also the increased scrutiny of systems, data and outcomes, which have made a number of recent inspections particularly detailed and intense. This is the new reality of FDA oversight.
Webinar Covers:

vender qualification, quality audits
supplier assessment and performance and quality agreements
manufacturing processes, validation and packaging
finished product specifications; container, closure, label, product
testing for release

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.
Who Should View?

Owners, CEOs and management responsible for corporate compliance with FDA requirements.
QA/QC staff responsible for establishing specifications and testing of components.
Manufacturers, contract manufacturers and private label producers responsible for ensuring the compliance of homeopathic products.
Marketers of private label brands who are responsible for the compliance of their contract manufactured product’s quality, safety and labeling.

Our Presenters:
Janeen Skutnik, a partner at NSF, speaks about establishing specifications, testing and conformance to specifications for materials, components and especially finished products. Her guidance will be valuable to manufacturers and contract marketers in better understanding the breadth and depth of the testing and documentation which is needed for OTC drugs
Pejman Parhami, Director of Quality Systems with Standard Homeopathic, speaks to supplier management vender qualification, quality audits, supplier assessment and performance and quality agreements. This very informative section will be important to both manufacturers and private label marketers.
Steve Mann, Head of Global Regulatory Affairs & Quality Assurance at Nelsons Int. UK speaks about the challenges manufacturers and contract marketers face in meeting FDA expectations for manufacturing homeopathic drugs, filling and finished product specifications.
This 2 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 $149 (includes S&H); AAHP members get a $100 discount.
Click here to order

Managing Contract Manufacturing Responsibilities and Relationships Webinar Archive
2015-01-08 - 2018-01-07 | Webinar Archive
AAHP Compliance Thru Education Webinar ARCHIVE
Don’t put your business at risk by not thoroughly understanding and implementing the responsibilities & duties of a contract manufacturing and marketing relationship!
The Food and Drug Administration Safety and Innovation Act (FDASIA) profoundly affects all contract manufacturers and contract marketers. With the many changes elucidated by FDA, one thing is clear: the contract relationship puts both parties at considerable risk if either one fails to follow through on its obligations.
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.
FDA inspects both contract manufacturers and contract marketers. Here are examples of the FDA’s comments in recent months to contract manufacturers and marketers:

Contract Marketer – your firm has not established any written specifications for your finished products for your contract manufacturer and has failed to test any received lots of products for conformance to specifications.
Contract Manufacturer – your firm does not have adequate procedures for production controls designed to assure that the drug products you manufacture have the identity, strength, quality and purity they report or are represented to possess.
Contract Marketer – your firm failed to conduct an investigation into numerous consumer complaints associated with broken or damaged tablets and bottles.
Contract Manufacturer – your firm relies solely on the supplier’s COA for quality assurance of components and raw materials and has failed to establish written specifications for these materials and components and has not performed specific identity testing for approval for use and has not established the reliability of the supplier’s analysis through appropriate validation of the suppliers test results.
Contract Marketer – your firm failed to establish product specifications for each of your contract manufactured products and failed to test each lot of finished product for conformance to specifications or manufacturer’s COA.
Contract Manufacturer – your firm failed to establish adequate procedures for the quarantine, sampling, inspection, review, accuracy and approval of labeling supplied by contract marketers for all contract product labeling.

FDA is giving increasing attention to setting, validating and meeting product specifications. And the Agency increasingly expects both partners in a manufacturing relation to be equally responsible for many aspects of quality.
Contract manufacturers and contract marketers represent a major segment of the homeopathic industry, which is growing with new labels, marketers and manufacturers added each year. The FDA treats these relationships seriously, citing manufacturers for failure to meet GMPs, failure to list contract manufactured products and the lack of stability data. On the other side of the relationship, the FDA has cited contract marketers for failure to meet GMPs for their products due to contract manufacturer failures, failure to audit contract partners and for labeling errors.
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 the Presenters
Three industry leaders discuss the requirements and responsibilities of contract manufacturing relationships, agreements and complying with FDA cGMPs. At least 5 take-away handouts provide sample audit forms and suggested quality contract language to get you started, or to help clarify and improve your present agreements and implementation.
Cathy Raish, Quality & Regulatory Manager for Heel Inc. Cathy has over 25 years experience working in the homeopathic OTC and prescription drug industry with responsibilities for quality and regulatory compliance. She works closely with purchasing, suppliers, manufacturing, and distribution to help create a robust, GMP compliant supply chain for products manufactured at Heel for both branded and contract manufacturing products. Cathy is a member of APICS, The Association for Operations Management and ISPE, the International Society for Pharmaceutical Engineering and was recently accepted as an associate member of HPUS where she serves on the Council of Pharmacy and Standards and Controls Committees.
Robert Cohanim, owner Historical Remedies is a multicultural resident who immigrated to the US from Europe and the Middle East in the mid 1970s. He has a BA from Macalester College in St. Paul, MN, and an MA in interdisciplinary studies from the University of Minnesota. His interest in homeopathy developed soon after graduating, as a result of his exposure to the health care systems in France and other European countries. Robert founded Historical Remedies in the late 1980s in order to give a more accessible face to over-the-counter medicines, and to inspire a positive approach to self-care through homeopathy.
Travis Borchardt has spent 13 years at Enzymatic Therapy and Schwabe North America setting the standards of quality assurance, quality control, and regulatory compliance for products sold as dietary supplements, OTC homeopathic drugs, OTC monograph drugs, cosmetics, foods and a European Union (EU) prescription pharmaceutical. He has incorporated good laboratory practices, and transparency with governmental agencies; helping earn the following titles: National Sanitation Foundation’s (NSF’s) Good Manufacturing Practices (GMP’s) Certification, United States Department of Agriculture’s (USDA’s) National Organic Program Certification, and Therapeutic Goods Administration (TGA) GMP Certification. As a current board member of the American Association of Homeopathic Pharmacists (AAHP) and the American Herbal Products Association (AHPA), Travis helps to shape industry business and quality standards for the homeopathic and dietary supplement industries.

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.

Click here to order

The Homeopathic Market – Analytical Tools for Understanding and Growth Webinar Archive
2015-01-07 - 2018-01-07 | Webinar Archive
Homeopathic consumers, users and supporters are a breed apart. They are that special segment of the natural products / natural health consumer population that supports and uses complimentary medicines. All homeopathic manufacturers and marketers would be excited to learn more about these unique consumers, their interests, motivations and purchasing habits.
Now there is an opportunity to do just that!
IRI is a leader in delivering comprehensive market and shopper information based on their own data collections augmented by other sources, such as SPINS, etc. And they provide the predictive analytics to help companies utilize the data in helpful and meaningful ways. IRI showcases the tools available to help understand and thrive in the homeopathic market with the growing segment of homeopathic consumers. IRI will draw on their extensive experience with:
Consumer understanding – consumer analytics, marketplace insights, survey solutions
Growth and new product innovation – foresight, launch forecasting, product profiles
Marketing performance and management – market testing, price& trade advantages, analytics
Sales and channel management – shopper behavior, new products, packaging, pricing and promotion
Shopper –Centric Collaboration – insights, analytics, solutions loyalty
This presentation is tailored especially for the homeopathic market on IRI’s data collection and analytical tools. Be prepared to gain insights into how you can find out more about your customers and potential customers. Plus a fresh view of the analytics at hand to help your company make the most of the information available. This 45 minute webinar will provide you with a concise overview of IRI and the importance of well-executed analysis on our homeopathic market.
Who should view this archive?

Owners, CEOs and management responsible for overall market and sales growth.
Marketing managers and staff responsible for marketing campaigns and new product launches.
Manufacturers, contract manufacturers and private label producers responsible for product development and support of their clients’ marketing.
Marketers of private label brands responsible for the marketing their homeopathic products.

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 $179 (includes S&H); AAHP members get a $90 discount.
Limited Time Special Package Pricing: order this DVD plus the Consumer Trends and Insights Webinar Archive at the same time and get both for $269 (includes S&H). That’s a savings of $90 over ordering them separately. AAHP Members save even more: order both at the same time and get a $130 discount.

How To Survive a Product Recall Webinar Archive
2015-01-06 - 2018-01-05 | Webinar Archive
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.
Click here to order.

FDA Hot Topics - Webinar Archive
2015-01-05 - 2018-01-04 | Webinar Archive
AAHP Compliance Thru Education Webinar ARCHIVE
Current FDA activities emphasize compliance with 21 CFR 211 Subpart E for components and raw materials. The FDA has repeatedly stated: all raw materials must receive at least an ID test to confirm it is the correct material according to the HPUS, USP or other appropriate authority. Marketing companies have received warning letters about labeling controls and inventory practices. Manufacturers have been issued warning letters and FDA-483 inspection reports for failure to adequately control incoming materials including quarantine, release, evaluation and identity testing.
This webinar provides an overview for marketers and manufacturers of the regulations establishing the requirements for components, raw materials and labeling, starting with the establishment of specifications and covering receiving, sampling, evaluation and testing for release or rejection. The FDA has made written specifications, identity testing and labeling controls a mandate in its inspection of manufacturers. Manufacturers are responsible for following these regulations and private label marketing companies are responsible for making certain their manufacturing partners are in compliance. Failure to follow these regulations can result in the issuance of FDA warning letters and product recalls.
Compliance in these critical quality areas is essential to the identity, quality and safety of homeopathic products and is the responsibility of private label marketers and manufacturers alike. Sometimes, an innocent action is actually a critical lapse of compliance. For instance:
Is it acceptable for a firm to use drug components, drug product containers, or drug product closures simultaneously with testing and/or prior to determination of conformity to all specifications? {References: Federal Register Vol.43 No. 190, 9/29/78, 45013 [at 45045]}
No. It is not acceptable to use drug components containers, or closures prior to completion of all testing to determine conformance to established written specifications. The above preamble to 21 CFR 211.84, clearly states that the use of drug components, containers, or closures prior to completion of testing for conformity to specifications violates the precept of good quality control because untested and possibly non-compliant materials would be used in drug product processing. This type of procedure substantially increases the risk to the consumer that an unsatisfactory lot might erroneously be released. {From FDA Human Drug CGMP Notes, Vol. 4, No. 4, December 1996 The Division of Manufacturing and Product Quality, HFD-320, Office of Compliance, CDER, Project Manager: Paul J. Motise, HFD-325.}
This webinar presents an overview of FDA cGMP and Homeopathic Pharmacopoeia requirements for testing of packaging components and active ingredients. The webinar is designed as a compliance overview for private label marketers and manufacturers and will address the regulations for conformance of homeopathic drug products. Compliance with 21 CFR 211 Subpart E, for raw materials, is critical to product quality and safety. Manufacturers are responsible for following these regulations and private label marketing companies are responsible for making certain their manufacturing partners are in compliance.
Example of observations in recent FDA 483’s for failure to identity test raw materials:

You did not follow your written procedure, “Approval/Rejection of Raw Materials and Packaging Components” for collecting representative samples of each unique shipment of components. Under 21 CFR Subpart E, you must establish and follow written procedures for fulfilling the requirements of subpart E. This subpart includes the requirement that you collect representative samples of each unique lot of components (21 CFR 211.80).
The inspection revealed the following deficiencies: 1. You failed to determine whether specifications are met before use of components as required by 21 CFR 211.84. Specifically, you failed to conduct at least one appropriate test or examination to verify identity of a drug ingredient prior to its use. From the time period between June 25 and October 6, 2009, you did not perform identity testing on any drug ingredients that you received, and during the time period between October 6, 2009 and May 10, 2010 you only performed identity testing on randomly selected drug ingredients.
Your firm failed to reject any lot of components that did not meet the appropriate written specifications for identity, strength, quality and purity [21 C.F.R. § 211.84(e)]. For example, a [redacted] raw material (lot (b)(4)) failed to meet specifications and was not rejected. The raw material was subsequently used to manufacture [redacted] (b)(4)). These lots were released and distributed.
Failure to verify the identity of each component of a drug product, as required by 21 C.F.R. § 211.84(d)(1). Components used in all drug products are not tested for identity. For example, the active ingredient [redacted] USP, used in [redacted], batch (b)(4) was not tested.
For example, your firm does not have a sampling and test procedures designed to assure that the water from the purification system conforms to appropriate standards.
Your firm failed to conduct at least one appropriate test or examination to verify the identity of a drug ingredient prior to its use, to comply with 21 CFR 111.75(a)(1)(i).
The CGMP deviations documented during the inspection include, but are not limited to, the following: Laboratory controls do not include determination of conformance to appropriate written specifications for the acceptance of each lot within each shipment of components used in the manufacture, processing, packing, or holding of drug products, as required by 21 CFR 211.160(b)(1).

These recent FDA activities emphasize compliance with 21 CFR 211 Subpart E for components and raw materials. The FDA has repeatedly stated that all raw materials must receive at least identity testing to confirm it is the correct material according to the HPUS, USP or other appropriate authority. Marketing companies bear responsibility to ensure that their products are manufactured under cGMPs and have received warning letters about labeling controls and inventory practices, and for failure to adequately control incoming materials including quarantine, release, evaluation and identity testing. All homeopathic drug manufacturers are responsible for following these regulations and private label marketing companies are responsible for making certain their manufacturing partners are in compliance.
In this Seminar you will learn the importance of…

Protecting your consumers and your business by meeting the FDA regulatory requirements for specifications, receiving, testing and evaluating components, labeling and raw materials
Ensuring product quality with the establishment of material and component specifications
Confirming raw materials with required identity testing
Compliance with FDA ‘hot button’ inspection issues

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.
Who should view this webinar?

Manufacturers, contract manufacturers and private label producers responsible for ensuring the compliance of homeopathic products.
QA/QC staff responsible for establishing specifications, sampling, evaluating and testing of components and materials.
Marketers of private label brands who are responsible for the compliance of their contract manufactured product’s quality, safety and labeling.
Personnel required to maintain appropriate and documented training in current Good Manufacturing Practices.

Meet the Presenters:
Rachael Carlisle Roehrig, Ph.D.–Director of Technical and Scientific Affairs for the Regulatory and Scientific Affairs department of the Consumer Healthcare Products Association (CHPA), coordinator for CHPA’s Product Quality & Operations Workshop and the CHPA liaison to the Manufacturing Controls Committee. Rachael presents FDA regulations 21CFR 211 Subpart E – Control of Components and Drug Product Containers and Closures and requirements. She will discuss specific quality processes, requirements for specifications, documentation and required identity testing.
Eric Foxman, RPh—Executive Secretary for the AAHP, Board Member of the HPCUS, and consultant on regulatory and GMP issues with over 30 years of involvement in homeopathic pharmacy and manufacturing. Eric discusses the HPUS requirements for testing of starting materials, botanicals and chemical substances, and for finished tinctures, providing examples of material specifications and identity testing requirements.

Kevin Carrasco—VP, Speed Laboratory Inc Kevin will review the reasons for the use of USP and NF testing methods for most excipient and for some homeopathic ingredients. He presents examples of the identity testing requirements for some of the most common homeopathic product excipients and active ingredients and cover basics in good laboratory practices for manufacturers.
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.
Click here to order

Homeopathic Market – Consumer Trends and Insights Webinar Archive
2015-01-04 - 2018-01-04 | Webinar Archive
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, could help fuel the growth of homeopathic remedies. Furthermore, product recalls of various OTC nonprescription medications likely have consumers looking for what they perceive to be as “safer alternatives”. How can your company benefit from the research and information that already exists about this market that is essential to your company?
Mintel, the leader in consumer research, presents 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, presents key findings and insights gleaned from their extensive 120 page 2013 report, Homeopathic and Herbal Remedies. Emily also draws upon Mintel’s 2011 similar report for a longer range overview of emerging trends.
View the AAHP presentation on Mintel’s research and conclusions on the homeopathic market and learn more about your customers and their natural health needs and preferences as well as gaining an understanding of important trends in the market. This 45 minute webinar will provide you with a concise overview of important information contained in Mintel’s extensive market research report.
Who should view this Webinar Archive?

Owners, CEOs and management responsible for overall market and sales growth.
Marketing managers and staff responsible for marketing campaigns and new product launches.
Manufacturers, contract manufacturers and private label producers responsible for product development and support of their clients’ marketing.
Marketers of private label brands responsible for marketing their homeopathic products.

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 $179 (includes S&H); AAHP members get a $90 discount.
Limited Time Special Package Pricing: order this DVD plus the Analytical Tools for Understanding Webinar Archive at the same time and get both for $269 (includes S&H). That’s a savings of $90 over ordering them separately. AAHP Members save even more: order both at the same time and get a $130 discount.
Note: The 2013 Mintel report, Homeopathic and Herbal Remedies can be purchased directly from Mintel Corporation at http://store.mintel.com/homeopathic-and-herbal-remedies-us-march-2013. A copy of the report will not be included in the Webinar handouts.
Click here to order.

Homeopathic Pharmacopeia -- 2013 Updates: What Might Affect Your Business Webinar Archive
2015-01-03 - 2018-01-02 | Webinar Archive
AAHP Compliance Thru Education Webinar ARCHIVE
The Homeopathic Pharmacopoeia of the United States, HPUS, as an official compendium recognized by the FDA, is critical to every manufacturer, formulator and contract marketer. You know the HPUS is a key reference for the manufacture of homeopathic medicines. But do you also know it is a continually updated and expanding guide? 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.
This short, efficient web-seminar will help you to stay on top of these changing guidelines as it relates to your regulatory compliance. In this web-seminar, hear from the President of the HPCUS as to why the pharmacopeia is important to homeopathic manufacturing and marketing, and how to apply the guidelines to the legal and regulatory status of your homeopathic products under the FDA.
This Webinar Covers:

The most commonly used 12 dosage forms and HPUS guidelines for manufacturing and labeling each
Revised HPUS guidance for what should be on the labels of combination products
The variety of methods for making tinctures — beyond simple maceration
Updates to validated official quality control tests that can be used by QA labs.

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.
Who Should View?

Owners, CEOs and management responsible for overall corporate compliance with updated HPUS guidance and FDA requirements.
Marketing managers and staff responsible for compliant labeling.
QA/QC staff responsible for establishing specifications and testing of components.
Manufacturers, contract manufacturers and private label producers responsible for ensuring the compliance of homeopathic products.
Marketers of private label brands who are responsible for the compliance of their contract manufactured product’s quality, safety and labeling.

If you are responsible for

overall corporate compliance (HPUS & FDA)
compliant labeling
for establishing specifications and testing of components
ensuring the compliance of homeopathic products
the compliance of your contract manufactured product’s quality, safety and labeling

… then this webinar is worth 1 hour of your time to stay abreast of these changes and their impact on your business.
Meet the Presenters
John P. (Jay) Borneman, PhD, President HPCUS is the fourth generation of his family in the profession of homeopathic pharmacy and has been associated with homeopathic pharmacy throughout his life. He is a principal owner of Standard Homeopathic Company and also serves as CEO of Hyland’s, Inc., the company’s wholly owned distribution subsidiary. Dr. Borneman serves on the Boards of the Homoeopathic Pharmacopoeia Convention of the United States as its President, Consumer Healthcare Products Association as Chairman of the CHPA Political Action Committee, Southwest College of Naturopathic Medicine; and as an emeritus director of The National Center for Homeopathy. He is has chaired the Legal and Regulatory Affairs Committee of the American Association of Homeopathic Pharmacists since 2001.
Eric L. Foxman, R.Ph. Senior Scientist HPUS attended his first Homeopathic Pharmacopia meeting in 1978 and has been a member of the HPCUS since its inception. In the interim, he has chaired the Pharmacopia Revision Committee, been an active member of the Standards and Controls committee since it’s formation and is presently chair of the Council on Pharmacy, while also serving on the Board of Directors of the Convention. Over the last 7 years, he has worked with the members of the Council on Pharmacy to completely review and revise the General Pharmacy Section of the HPUS leading to the creation of the all-new Guidelines for Manufacturing Homeopathic Medicines, new Labeling Guidelines and a revision of the Homeopathic Good Manufacturing Practices Guidelines. Concurrently, Eric has been a member or company representative of the American Association of Homeopathic Pharmacists for 35 years, and is presently serving his third stint as Secretary of that organization.
This 1 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 $159 (includes S&H); AAHP members get a $50 discount.

Click here to order

Homeopathic Labeling: The FDA Is Watching - Webinar Archive
2015-01-02 - 2018-01-02 | Webinar Archive
AAHP Compliance Thru Education Webinar ARCHIVE
More than at any other time, the FTC and FDA continue to increase their scrutiny of homeopathic drug labeling and advertising. In order to protect your consumers, your brands, and your business, it is critical to have a thorough understanding of regulatory requirements.
This webinar provides a comprehensive overview of the requirements of the FDA Compliance Policy Guide for Homeopathic Drug Products, the HPUS Labeling Guidelines, and the regulations governing drug labeling and claims across the marketing mix, from product labels to websites to advertising.
In This Webinar Archive You’ll Learn How To:

protect your consumers, products, brands, while avoiding costly errors by complying with all HPUS and required FDA labeling requirements.
ensure your label has the required Drug Facts panel and warnings, and that you have the necessary substantiation and controls necessary for all claims.
create advertising, websites, POS, and other communications that maximize competitive advantage while adhering to the required labeling regulations.
distinguish OTC from Rx claims.

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.
Who Should View:

Manufacturers, private label producers, distributors, and or marketers of homeopathic products.
QA/QC professionals, marketing/PR staff, packaging/regulatory managers, and executives who manage or oversee labeling, consumer communications, and/or risk management.

This efficient 2.5 hour webinar archive features an expert panel of noted homeopathic industry consultants discussing the current regulatory guidelines, potential pitfalls to avoid, developing corporate guidelines/GMPS, as well as an Question and Answer period to addresses individual issues:
Meet the Presenters
Al Lorman Esq — AAHP counsel and authority on the Compliance Policy Guide. Al provides an overview of the FDA & FTC Advertising Review Process, an overview of recent enforcement actions and warning letters, and provides guidance for avoiding these mistakes. He also discusses OTC vs. Rx claims, and regulation of products containing both homeopathic and other allopathic drugs or supplements.
Eric Foxman, RPh –Secretary for the AAHP, Board Member of the HPCUS, and consultant on regulatory and GMP issues with over 35 years of involvement in the homeopathic pharmacy and manufacturing. Eric discusses the labeling requirements of the HPUS, the drug facts statements, and critical points regarding label formats and dosing, as well as requirements for marketing to adults vs. children.
George Bernstein PhD — Pharmaceutical consultant improving the efficiency, compliance, and quality of small, medium, and large domestic and global pharmaceutical companies. George provides guidance on creating a claims substantiation file, on using all the correct warnings for safety and specific condition claims. He also reviews proper cGMPs of labeling, approvals/sign off, change control, revision numbers, and label inventory controls.
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.
Click here to order.

Homeopathic Pharmacopeia – 2014 Updates – Is Your Company Ready? Webinar Archive
2015-01-01 - 2018-01-01 | Webinar Archive
AAHP Compliance Thru Education Webinar ARCHIVE
In 2014, the Homeopathic Pharmacopeia Convention of the United States (HPCUS) completed another round of updates building on the changes that were drafted in 2013 and approved for final publication in April of that year. In addition to the finalized and approved Guidelines for Manufacturing Homeopathic Medicines, four new documents were posted for public comment, as well as 6 new monographed substances. This webinar archive provides an orientation to these changes as well as discusses the implementation schedule for the guideline documents.
Three members of the HPCUS present overviews of the approved changes and the public comment period for the draft documents. Eric Foxman has been deeply involved in the drafting and revisions of these important guideline documents for the past several years. He is joined by AAHP Board member Mary Beth Watkins, who has been leading the drafting of a brand new guideline document on Homeopathic Drug Stability Guidelines. The third presenter will be Eric Baier, a member of the HPCUS Council on Pharmacy, where he chaired the ad hoc subcommittee that created an updated Homeopathic Labeling Guideline document.
View this AAHP presentation on the 2014 changes and proposed updates to the HPUS. This 90 minute webinar archive will provide you with a concise overview of important information contained in the new guideline documents as well as giving you insights into how comments on the proposed changes can be submitted to the HPCUS. The Archive DVD contains all the handouts available during the original on-line event.
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.
Who should view this webinar?

Owners, CEOs and management responsible for regulatory compliance.
Staff responsible for compliant labeling.
QA/QC personnel who need to know the guidance information provided by the HPUS for stability assurance.
Manufacturers, contract manufacturers and private label producers responsible for product development and support of their clients’ marketing.
Marketers of private label brands responsible for compliant labeling of their homeopathic products.

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 $239 (includes S&H); AAHP members get a $100 discount.

Click here to order.

Members’ Meeting Is Just Around The Corner
2014-09-19 09:00 - 11:30 (America/New_York) | Holiday Inn Baltimore-Inner Harbor, 301 West Lombard Street, Baltimore, MD, 21201, United States
Plan to attend the AAHP’s Semi-Annual Membership Meeting in Baltimore, MD on Friday, September 19. We plan on giving our members updates on our activities as well as a special presentation during the meeting. More information will follow in a future NetworkNews.
As usual, the meeting will be held in conjunction with Natural Products ExpoEast, on Friday morning, September 19 in the Holiday Inn Downtown Hotel. This is the same location as our last two September meetings, and is located at 301 West Lombard Street, just a block from the Convention Center. Accommodations in Baltimore are going fast, so be sure to get your overnight rooms soon so you can attend.
