Compliance with regulatory standards is one of the most important aspects of pharmaceutical manufacturing. Ensure your processes and procedures are current with new regulations by attending the 2017 PDA Regulatory Course Series, Sept. 14-15, following the 2017 PDA/FDA Joint Regulatory Conference.
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Select from the following courses in the series:
 
CMC Regulatory Requirements in Drug Applications (Sept. 14)
This course will cover chemistry, manufacturing and control (CMC) requirements in investigational new drug (INDs) applications, new drug applications (NDAs), abbreviated new drug applications (ANDAs), drug master files and post-approval changes. Content will help prepare those in regulatory affairs to better address key points required in the CMC sections of drug applications.
 
Quality Culture and Investigations: Best Practices (Sept. 14-15)
In this comprehensive course, discover the critical support elements of investigations, including quality culture, integration of quality risk management and continuous improvement. Attendees will also learn the necessary components in designing an investigation and conducting a root cause analysis, which will determine the true root cause and yield the most effective CAPAs.
 
CMC Regulatory Compliance for Biopharmaceutical Manufacturing (Sept. 14-15)
Become informed about developing a successful and effective strategy for CMC. Noted industry experts will provide insights and practical guidance for CMC teams to develop an acceptable, cost-effective CMC regulatory compliance strategy for biopharmaceuticals from early clinical stage development through market approval. The course will emphasize U.S. FDA, EMA and ICH guidance.
 
Preparing for Regulatory Inspections for the FDA and EMA (Sept. 14-15)
Do you have questions about how to prepare to host a GMP or pre-approval inspection? Attend this two-day lecture course and take an in-depth look at U.S. FDA and EMA inspection authority and practices. Important references to use for preparation for inspections will be highlighted. Recent changes to U.S. FDA inspection authority covered in the FDA Safety and Innovation Act (FDASIA) legislation and the resulting changes that may be needed in company inspection management procedures and training will also be covered.
 
 
PDA is accredited by ACPE and offers continuing education for professional engineers.
 
Receive the same training regulators receive when you attend a PDA course. Visit pdatraining.org for a comprehensive list of all course offerings.
 
 

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