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BEGIN:VEVENT
DTSTART;VALUE=DATE:20150109
DTEND;VALUE=DATE:20180109
DTSTAMP:20260520T121847
CREATED:20140127T204309Z
LAST-MODIFIED:20150123T183007Z
UID:10000053-1420761600-1515455999@theaahp.org
SUMMARY:From Leaf to Label - Quality Throughout the Cycle -- Webinar Archive
DESCRIPTION:AAHP Compliance Thru Education Webinar ARCHIVE \nAnyone 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. \nVender 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. \nEnsuring 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 \nThe 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. \nWebinar Covers:\n\nvender qualification\, quality audits\nsupplier assessment and performance and quality agreements\nmanufacturing processes\, validation and packaging\nfinished product specifications; container\, closure\, label\, product\ntesting for release\n\nNote: 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. \nWho Should View?\n\nOwners\, CEOs and management responsible for corporate compliance with FDA requirements.\nQA/QC staff responsible for establishing specifications and testing of components.\nManufacturers\, contract manufacturers and private label producers responsible for ensuring the compliance of homeopathic products.\nMarketers of private label brands who are responsible for the compliance of their contract manufactured product’s quality\, safety and labeling.\n\nOur Presenters:\nJaneen 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 \nPejman 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. \nSteve 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. \nThis 2 hour Webinar DVD also contains all the handouts available during the original on-line event. \nWebinar 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. \n[button color=”blue” url=”mailto:info@theaahp.org?subject=Leaf to Label Webinar Archive Inquiry” size=”small”]Click here to order[/button]
URL:https://theaahp.org/event/from-leaf-to-label/
LOCATION:Webinar Archive
CATEGORIES:Webinar,Webinar Archive
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20150110
DTEND;VALUE=DATE:20180110
DTSTAMP:20260520T121847
CREATED:20140127T203742Z
LAST-MODIFIED:20150123T183039Z
UID:10000054-1420848000-1515542399@theaahp.org
SUMMARY:Managing Consumer Calls: Complaints\, cGMP Compliance\, Quality and Service Webinar Archive
DESCRIPTION:AAHP Compliance Thru Education Webinar ARCHIVE \nCustomers 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. \nCustomer 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. \nIn 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. \nThe 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. \nIgnoring 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. \nManufacturers 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. \nPrivate 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. \nNote: 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. \nThis Webinar Covers:\n\nWhat the cGMP requirements are for marketers and manufacturers of drug products in managing consumer complaints;\nHow to conduct a thorough investigation of the complaint;\nImportance and tools for investigating consumer complaints;\nThe requirements and value of performing corrective actions.\n\nAbout Our Presenters\nAlvin 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. \nMary 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. \nWalt 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. \nThis 2.5 hour Webinar DVD also contains all the handouts available during the original on-line event. \nWebinar 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. \n[button color=”blue” url=”info@theaahp.org?subject= Managing Consumer Calls Webinar Archive Inquiry” size=”small”]Click here to order[/button]
URL:https://theaahp.org/event/managing-consumer-calls-complaints-cgmp-compliance-quality-and-service/
LOCATION:Webinar Archive
CATEGORIES:Webinar,Webinar Archive
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20150111
DTEND;VALUE=DATE:20180111
DTSTAMP:20260520T121847
CREATED:20140127T202949Z
LAST-MODIFIED:20150123T183958Z
UID:10000056-1420934400-1515628799@theaahp.org
SUMMARY:Best Branding Practices Webinar Archive
DESCRIPTION:How to make your product stand out in a crowd: selling products\, services and your company’s image. \n\nThe Homeopathic market place is estimated to have have reached $1 billion in sales in 2011 and is still growing!\nAnnual growth has been estimated at between 3 and 5%.\nBranding your company\, products and services to differentiate you from the crowd while accelerating your growth is now more important than ever.\n\nHomeopathic companies and products must work harder than ever before to stand out in today’s crowded marketplace of natural and OTC drug products. Reaching the consumer with your message\, image and benefits through the multitude of competing products and messages is tough to accomplish. Consumers are seeking solutions and at the same time are rushed and pressured and faced with a multitude of competing messages. Your brand’s image and message must be on target to capture their attention\, help them relate to your product and make them your customer. \nEvery Company\, every brand and every product competes for store placement\, shelf space\, advertizing space and retailer and consumer attention. Gone are the days of using trade show booths\, shelf talkers and magazine ads to reach retailers and consumers. Today’s market is one of diverse communication channels and all of these channels can lead to consumers\, sales and growth. Reaching out through established and new media channels still requires that the basics of good branding are accomplished with the added challenge of embracing greater consumer interaction through websites and new and interactive media. \nThis Webinar Covers\n\nThe latest information on what drives consumer trends and what consumers are saying about homeopathic products.\nDefining and differentiating your brand – what is branding\, how to define your brand and the art of standing out from the crowd.\nCreating clear\, consistent AND motivating brand messages across all customer touch points from consumer promotions to retail outlets to websites and media. Expert advice from a homeopathic marketer who expanded a brand’s sales and marketing reach while expanding the product line.\nThe emerging ‘New Media’ opportunities of the internet and social networking in brand and image building and management.\nHow to build a brand on any budget.\n\nWho Should View…\n\nOwners\, CEOs and management responsible for band and company mission\, image\, sales and growth\nMarketing managers and staff responsible for advertising\, media and message\nDesigners and marketers responsible for product image\, package design and labeling\nManufactures and service suppliers to the homeopathic industry for how to promote your services to the industry and maximize your company’s image and message\n\nMeet the Presenters\nBob McNabb\, Business Director for Natural Marketing Institute. NMI is an international strategic think tank\, specializing in health\, wellness\, and sustainability since 1990 with full-service market research resources. NMI’s annual\, syndicated consumer database allows them to keep their finger on the pulse of consumer trends. Bob addresses homeopathic medicines’ household penetration\, perceived effectiveness\, perceived safety\, and the usage (increased/ decreased/ stayed the same) of homeopathic medicines. \nCynthia Batterman is the Principal at Essex Consulting. Cynthia is a senior marketing executive and general manager with a strong track record of transforming and building businesses in both private and publicly traded companies. Previously as President of Nelsons she is credited with the development of a pipeline of new products\, winning 5 “best new product of the year” awards\, and generating record levels of sales and profits for Nelsons. With an additional 15+ years of experience in Fortune 500 companies as well\, so is skilled at developing “big company strategies” on “small company budgets.” Cynthia is a Board member on the AAHP\, is past Chair of the Education Committee\, and is currently Chair of the Publicity Committee. Cynthia speaks about brand positioning strategies … what Branding is\, how to create one\, and why it is important to a company’s long-term strategy and growth. \nTara Deville\, National Director of Media\, Brand Digital\, presents Digital Connection Marketing\, the art and science of crafting two-way interactions online that inject meaning\, interest and emotion into an audience’s experience of a brand. By continually pushing to better define audiences\, we help uncover the insights that inspire and shape communications and connections. Brand Digital clients include many well-known pharmaceutical companies such as Novartis\, Merck and Roche\, as well as Kellogg’s\, Sears\, St. Jude’s Hospital\, and Budweiser. \nDanielle Conte\, creative energizer\, insights wizard and super strategist at Vertical Marketing Network\, LLC will be speaking on how to translate your brand into consumer marketing campaigns which are full of market insights and bright and bold ideas … while driving sales and strong returns on investments. Danielle works to create new marketing approaches\, opportunities and innovation that lead the way to meeting and exceeding business and sales objectives. Vertical’s. Client list include ConAgra Foods\, Unilever\, Warner Bros.\, Abbot Medical Optics\, Mead\, Del Monte\, and GE Capital. \nThis 2.5 hour Webinar DVD also contains all the handouts available during the original on-line event. \nWebinar 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. \n[button color=”blue” url=”mailto:info@theaahp.org?subject= Best Branding Practices Webinar Archive Inquiry” size=”small”]Click here to order[/button]
URL:https://theaahp.org/event/best-branding-practices/
LOCATION:Webinar Archive
CATEGORIES:Webinar,Webinar Archive
END:VEVENT
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