This webinar will discuss the impact of proper CGMP practices verses the impact of inappropriate activities and actions on your company.

1. Making API GMP work for YOU and Your
Company!
GMP
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. Get Connected With Us:
www.onlinecompliancepanel.com
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com