PTI - international

•  Assess the effect of post-approval changes on the identity, strength, quality, purity and potency and ensure that you produce a safe product
• Demonstrate that products manufactured prior to and subsequent to a change are equivalent
• Make and report changes to an approved application and meet SUPAC requirements

• Comply with reporting requirements for an Annual Report, Changes-Being-Effected Supplement, Changes-Being-Effected-in-30-Days Supplement and Prior Approval Supplement and remain in compliance
• Interpret FDA guidance documents related to post-approval changes and apply them to your products
• Use comparability protocols to save time and effort by reducting your reporting requirements and streamlining your processes
• Assess the level of risk posed by a change and prepare for difficult product adjustments
• Generate proper documentation to satisfy regulatory authorities 
• Determine the extent of validation needed for post-approval changes and meet the regulatory requirements
• Work with FDA in a collaborative manner to achieve and maintain compliance

PTi international is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmaceutical education. Participants will receive a maximum of 14 hours (1.4 CEUs) of continuing education credit for full participation in the two-day training. ACPE # 326-000-07-046-L04, Initial release: 08/2007.