cGMP - Current Good Manufacturing Practices Overview | QM-010
Course schedule to be announced
Course Length: 1/2 Day (4 hours)
Course Fee: $175.00
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Keep Your Business Healthy By Complying with FDA Good Manufacturing Practices
Current Good Manufacturing Practices (cGMP) are production and testing practices that help to ensure product quality. While applicable to almost any business, they are mandatory in certain industries. The FDA can levy significant penalties for non-compliance.
This seminar will introduce employers to the fundamental requirements of cGMP, their responsibilities under the law, and the potential financial liabilities to which they are exposed.
- History of cGMP
- Consequences of non-compliance
- The BASICS
- Why cGMP's should be followed
- Gap Analysis
Who Should Attend:
Owners and managers of small to medium businesses requiring cGMP for new contracts and effective business practices.
Ginger Blanda, BS Chemistry/ Bus Admin
Environmental Health and Safety Manager, Quality Assurance Professional
Ginger Blanda holds a Bachelor of Science Degree in Chemistry and Business Administration and credits towards an MBA in Business Administration. Ms. Blanda has over 20 years of professional experience as an Environmental Health and Safety Professional and a Quality Assurance Professional. She worked a majority of her professional career with Pall Corporation, an International filtration company. Ms. Blanda currently works as an Environmental Health and Safety Professional for Brookhaven National Laboratory.
During her career, Ms. Blanda has documented several procedures related to OSHA compliance and quality systems. In addition, Ms. Blanda is a certified ISO9001/ ISO14001 Auditor and a trained cGMP auditor. Ms. Blanda has performed numerous audits of safety and quality systems and prepared close out reports with guidance on corrective actions. Ms. Blanda is a Certified DOE Accident Investigator and a Green Belt in Lean Manufacturing/ 6 Sigma. Finally, Ms. Blanda is certified as completing the OSHA General Industry -30 hour training program.
Mark Marco, BSIE, MBA, CSP
Mark Marco has a B.S. in Industrial Engineering and a Master of Business Administration, MBA. He is also a Certified Safety Professional, CSP. He has over twenty (20) years experience as a safety professional having held the title Health and Safety Manager for major companies such as Pall Corporation and Raytheon Corporation. He is currently employed at Brookhaven National Laboratory as a Safety and Health Professional. During his career, he has documented policies and provided training for numerous OSHA programs such as, but not limited to, Lock Out/Tag Out, Confined Space, HAZWOPER, Fire Extinguishers, Powered Industrial Trucks (Forklifts), Hazard Communication, Personal Protective Equipment, Respirators, Emergency Planning, and Blood Borne Pathogens. He is forty (40) hour HAZWOPER trained and has held the position as Incident Site Commander for many chemical spill clean ups. He is trained to perform accident investigation using causal factors and root cause analysis. He has performed numerous “Mock” OSHA inspections and reports. He has managed a team to implement ISO 14001 and is a Certified ISO 14001 auditor. He is a Professional Member of the American Society of Safety Engineers.