Making API GMP work for YOU and Your Company!
GMP
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Instructor Profile:
Max Lazar retired from Hoffmann-La Roche Inc. in 2001 after 35 years, where he was Vice President, FDA & DEA Compliance. In that position he was responsible for compliance oversight of all of the Roche USA businesses including Active Pharmaceutical Ingredients, Pharmaceuticals, R&D, Diagnostics, Fine Chemicals and Vitamins. Following his retirement, he established a consulting business specializing in API GMP issues and the training of personnel covering the ICH Q7A Guidance as well as the Excipient GMP (IPEC) Guidance. As a voting member of the ICH Expert Work Group (EWG) that developed and negotiated this international standard, Max is uniquely qualified to share and explain the EWG’s intent of this new guidance. His almost 50-year career in the Pharmaceutical Industry includes numerous memberships and chairs of committees. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Description: GMP compliance, a fundamental requirement of Federal Drug Law, applies to various products that are subject to the US FD & C Act. Under this US law, Active Pharmaceutical ingredients (API) are subject to this Act's requirements. Historically, many organizations looked at CGMP as a mandated cost and not as an opportunity to improve a business. What this program will examine is how this legal requirement can, if properly executed, actually result in a significant business benefit to companies. How one applies the GMP's intent and requirements within a firm's GMP functions and organizations can actually yield a value added activity. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Why Should you Attend: If you or your company is subject to Drug GMP, then you can benefit from this Webinar. Whether you produce API or Drug products, you will potentially be able to profit from the instructor's almost 50 years of experience in the manufacturing and testing of drugs under the umbrella of GMP. Understanding the drug guidance and/or regulations that have applied to API and drug products is important to the bottom line impact of GMP. Understanding the rules of the game will make you a better and a more effective member of your firm's team. Learn what you need to implement and require when establishing practices and procedures. We will discuss the impact of proper CGMP practices verses the impact of inappropriate activities and actions. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Who can Benefit: • • • • • • • •
Firms that are subject to CGMP requirements. Doesn't really matter if you produce API or other drug products. Quality Control and any Quality Unit personnel Engineering and Production Management Management that thinks Quality units negatively impact the firm's income Purchasing and materials management personnel that believes that quality control is increasing their company's expenses Distribution personnel R&D personnel responsible for methods and procedures that will be used by API functions Regulatory Affairs personnel responsible for filing DMF, NDA, ANDA and another FDA related filings and registrations.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Objectives of the Presentation: • • • • • •
Establishing the right Corporate and Operating Quality Policy Define expectations of your policies and procedures Why is follow-up action important? Why is proper communication important between internal groups? What are the systems you need to define as critical? Why tracking trends can be invaluable?
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Live Session - How it works? Username and Password will be sent to you 24 hours prior to the webinar Presentation handouts in pdf formate will be mailed to you Login to the session using the username and password provided to you Get answer to your queries through interactive Q&A sessions via chat Get certification of attendance.
Recorded Session - How it works? A link will be provided to you upon purchase of the recorded session Please click on the link to access the session Presentation handouts in pdf formate will be mailed to you Get certification of attendance.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com