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.
- 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.
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.
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