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Packaging Components – QA and Compliance Practices
Dates Available: July 29, 2010
Cost: $480.00 + GST
Location: 200 Consumers
Road, Suite 200, Toronto, Ontario
A One-Day COMPREHENSIVE & INTERACTIVE COURSE
Receive a Credit toward the Diploma in Pharmaceutical QA/QC
Course Outline
- FDA and Health Canada regulations for container closure system
- Inspection and sampling techniques for PCs
- QA and documentations practices to be followed to meet compliance.
- QC testing of packaging components with direct product contact
- SOPs for packaging component inspections, sampling and QC testing
- PC and Packaging order correlation
- Do and Dont’s for packaging of pharmaceutical products
- Role of HDPE and LDPE, amber and other packaging material in pharmaceuticals
- Incoming packaging material control practices
- Assigning expiry date and inventory control for packaging material
- Significance of vendor qualification for approved packaging material
- How to manage NCRs and OOS for packaging material sampling and testing
- Assigning CAPAs
- How to handle customer complaints related to packaging material
- Implementation of good in process practices to control contamination from PM
Distinguished Faculty
Mr. Sarma.R.Donepudi
Director and Consultant
ScitechSolutions Inc.
Sarma.R. Donepudi is a Scientific and Technical professional with vast experience in cGMP, GDP, GLP, HACCP, IS14001, Quality Assurance, Environmental Research, SOP and Technical writing and Instrumental techniques, applicable to microbial and chemical quality evaluations in Pharmaceutical, Food and Environmental industries.
Sarma, also has specialized and trained several quality assurance professional in the areas of packaging component testing and container closure system applicable to pharmaceutical and medical device industries.
He has several years of knowledge, education and experience in Environmental-Monitoring, Compliance, Health, Testing, Auditing and Science Communication with special emphasis to Environmental Chemistry and health related projects. He authored around 20 technical publications in the fields of environmental microbiology, chemistry, health and toxicology in journals of repute. He was profiled as role model for environmental compliance specialists professionals on ECOCANADA website.
Mr.Sarma has acquired expertise in GMP, Internal, Third party and External audits in food, environmental, pharmaceutical, natural health products and medical devices industries. He has expertise with managing Change Control documentation, deviation reports and investigations to microbial and chemical out of specification results. He is an expert trainer and coacher in GMP, HACCP and Auditing practices in food and pharmaceutical industries. He was an invited speaker in many scientific conferences. Sarma, is currently working as part time instructor at Academy of Applied Pharmaceutical Sciences, Toronto, Canada and Managing Director for SCITECHSOLUTIONS
Sarma Donepudi served as Board of Directors for many organizations such as College of Chiropodists of Ontario, Ecovu Analytics Inc, Seneca College Mentor partnership program, National Occupational Standards for Environmental Practitioners in Canada, Chemical Institute of Canada, Toronto – Chapter, International Symposium on Global Warming, organized by National University Taiwan.
Who Should Attend
This course is valuable for all persons employed Quality Assurance, Quality control, and Manufacturing in the Pharmaceutical Industry including; Packaging Supervisors, QA in process technicians, QA coordinators, Packaging component , Technicians, QA samplers, Production Supervisors.
COURSE LOCATION
AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J
4R4
tel: 416-502-2277
www.aaps.ca
*Registration Fee Includes:
Presentation Materials, Luncheon, Refreshment and
Free Parking
*Please indicate any special Dietary requirements
when registering for the course
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