Good Documentation Practice (GDP) is a term in the pharmaceutical industry to describe standards by which documents are created and maintained. This practice is important where Health Canada, FDA, EMA, and other health authority regulations impose a special recordkeeping burden. In these industries, documentation serves both the scientific and compliance needs, and Good Documentation Practices are the set of activities that enable you to record your data and hand-written entries in a legible, traceable and reproducible manner.
· Regulatory Requirements for Documentation/Record Keeping
· Document types
o Commitment documents (i.e. new drug applications, new drug master files)
o Directive documents (i.e. specifications, STPs, SOPs, MPRs)
o Record documents (i.e. protocols, BPRs, log books, calibration records)
· Good documentation requirements
o Regular review and update
o Formal presentation
· Distribution of Documents by QA
· Archiving of documents
· Retention Periods
· Adverse Reactions and Adverse Reactions Reporting
· Inspections and Audits for documentation
· Live demonstration of a document management system
Who should attend
· Quality staff (reviewing raw data, lab notebooks, batch records, etc.)
· Regulatory affairs staff (verifying source materials)
· Authors, reviewers, and auditors of documents within Health Canada and FDA-regulated industries (i.e. pharmaceutical, Cannabis, Food, Medical device manufacturers, Cosmetics, Natural Health Products, and biotechnology)
· Project Managers
· Training Staff
· Operations staff
· Laboratory staff (generating data and maintaining lab notebooks)
· Clinical research associates (monitoring sites and resolving CRF queries)
· Engineering staff (keeping notebooks and executing batch records)
SPEAKER: Pr. Peivand Pirouzi
Peivand holds a Ph.D in Physiology and Biophysics School of Medicine, University of Sherbrook, and an MBA from American Business Administration Institute, and he is accredited by the Canadian Council of Pharmaceutical Education with certificates in Evidence Based Medicine, Psychiatry, and Management.
Peivand’s industrial experience includes Wyeth/Pfizer, ApoPharma/Apotex, as well as collaborations with EliteMed and Medipure Pharmaceuticals. His government and corporate training experience covers companywide pharmaceutical and sales training on a multitude of subjects. He has extensive pharmaceutical teaching experience to personnel ranging from Health Canada Inspectorate (in pharmacovigilance) to pharma industry organizations such as Nestle, Teva, Biopharma Services, 3M, Medipure Pharmaceuticals and Patheon.
He has authored more than 65 scientific realizations, including 12 publications in the National Library of Canada, articles in peer-reviewed journals, oral and poster presentations, and more than 100 technical and scientific reports.
|Student Ticket:||$250.00||— Sold Out|
|Basic Member Ticket:||$650.00||— Sold Out|
|Group Tickets (5+):||$555.00||— Sold Out|
|Pro/Pro Plus Member Ticket:||$575.00||— Sold Out|