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This webinar will discuss the US’s FDA Final Rule for current Good Manufacturing Practices (CGMPs) for combination products. In particular, it is intended to better understand the cGMP requirements for enforcement purposes.
Both domestic and foreign manufacturers are required to establish and maintain a quality management system (QMS) to the extent applicable for combination products (e.g., drug and medical device). The speaker will discuss how firms can achieve compliance with quality system regulations as well as how to achieve compliance with drug cGMP requirements for combination products. For example, do design controls apply when a device constituent part is used in a combination product? If so, what levels of design control would apply?
To achieve compliance and to remain compliant with the cGMP requirements applicable for combination products, it is critical that executives and managers understand and accurately interpret the applicable requirements so that compliance to cGMP requirements can be adequately, sustainably achieved.
This webinar will provide a great opportunity to get familiar with the cGMP requirements and greatly improve your awareness and confidence.
Areas To Be Covered in this Seminar:
• Applicable Laws and Regulations
• Current Good Manufacturing Practice (cGMP) Final Rule for Combination Products
• cGMP Requirements for A Co-Packaged Or Single entity Combination Product
• Implementing Compliance to Quality System Regulations
• Implementing Compliance to Drug cGMP Requirements
• Implementing Compliance to Biological Product and HCT/P Requirements
• Comparative Discussion on 21 CFR Parts 210/211, 600-680, 820, and 1271
• Common Misconceptions
• How to implement cGMPs for Combination Products
• Best Practices: Dos and Don’ts
• Speaker’s PASS-IT Recommendations
Who will benefit:
• Compliance Officers
• Regulatory Affairs
• Clinical Affairs
• Quality Assurance
• Anyone Interested in the FDA Drug Review and Approval Processes
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.
Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.