To deal with these complexities, the FDA published draft guidance for the application of GMP to combination products. The FDA determined that these requirements should be formalized in the Federal Register.  The proposed rule was published in 2009 and the final rule was published on December 22, 2012 and was effective July 22, 2013. This webinar discusses this final rule and describes approaches to comply.At the end of this session, you will be ableTo understand where the combination products GMP rule applies.To learn & understand the differences between drugs, biologicals comments and after devices & their modes of actions    To understand how they interact to produce combination products    To learn and understand how to apply the regulation to your product and operations    To gain additional perspective on how to apply quality principles to solve compliance problemsAreas Covered in the Session :    Objectives & Overview    The Draft Guidance vs. The Proposed Rule Vs. The Final Rule    A quick review of the Pharmaceutical, Medical Device, and Biological GMP Contents    A Quick Overview and Analysis Of Industry Comments and the FDA Responses    Who is in charge of your product CDER,CBER,CDRH    Scope, applicability and factors that impact the manufacturing    Quality and compliance perspectives of the Final Rule    FDA's discretionary enforcement of the Final Rule    Reviewing, Analyzing, & Understanding the Final Rule    21 CFR Part 4,  Subpart  A    Practical Suggestions for complying with Combination Product cGMP Subparts    Beyond the regulation and its impactWho Will Benefit:    QA / QC Managers and personnel    Regulatory Affairs    Product Management    Supervisors & Group Leaders    Production Management    Companies new to the FDA regulated industry    Purchasing    Compliance Management    Quality Unit Vice Presidents & Directors    Vice presidents, Directors and Managers of Operations    ConsultantsPrice Tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299Reach UsCompliance Trainings5939 Candlebrook Ct,Mississauga, ON L5V 2V6,CanadaCustomer Support : 416-915-4458