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The Trainer
Wayne A. Mazanec,
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| Who Will Benefit: |
- QA/QC
- Engineers
- Auditors
- Supervisors
- Investigators
- Directors
- Trainers
- Research
- Analysts
- Management
- Operators
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| Trainer Profile : |
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Wayne A. Mazanec, M.S.,
retired from FDA after 33 years of progressive positions from Investigator, Supervisory Investigator, Investigations Director, and then to Assistant Regional Director for the Pacific Region. His career in multiple locations involved extensive regulatory operations in a broad range of commodities. His work also involved training of agents throughout the U.S. for investigative work, case development and in the complexities of epidemiology.
Subsequent to retirement, he has audited, consulted, and trained clients in addressing CGMPs, GLPs, GCP requirements and has provided recommendations and advisory assistance for manufacturing and research firms throughout the U.S and in non-U.S. locations. He is Course Director for another CGMP system presented within the U.S. and in off-shore locations as well.
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Complying with GMP and cGMP Requirements -
Streamlining Quality Assurance & FDA Compliance
As part of Global Compliance Series of seminars, ComplianceOnline brings you the expert view on "Complying with GMP and cGMP Requirements - Streamlining Quality Assurance & FDA Compliance" by Wayne A. Mazanec, M.S., retired from FDA after 33 years of progressive positions from Investigator, Supervisory Investigator, Investigations Director, and then to Assistant Regional Director for the Pacific Region.
AGENDA ITEM
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Introduction |
Production / Processes |
Law |
1) System controls |
Regulatory history
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2) Procedures |
Regulatory development
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3) Documentation
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Statue update mechanism
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4) Reprocess / Rework |
Scope
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5) Qualification |
Definitions
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6) Validation |
Quality Control Unit
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7) Samples / tests
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| 1) Responsibilities |
8) Release
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2) Authority
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Packaging / Labeling
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3) Management
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1) Labels
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Personnel qualifications
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2) Labeling
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| Consultants |
3) Reconciliation |
| Facility features |
4) Security |
| 1) Grounds |
5) Release |
| 2) Areas |
Holding / Distribution |
| 3) Quarantine |
Laboratory |
| 4) Surfaces |
1) Procedures / Methods |
| 5) Utilities |
2) Validation |
| 6) Maintenance |
3) Documentation |
| Equipment |
4) Notebooks |
| 1) Construction |
Records / Reports |
| 2) Cleaning |
Master |
| Components |
Batch |
| Receipt |
Review |
| Storage |
Approval |
| Handling |
Returns / Salvage |
| Samples / tests |
Procedures |
| Release |
Records |
PRICING:
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Price INR* |
Savings |
| 1st July - 8th July |
17,000 |
2,000 |
| 9th July - 15th July |
18,000 |
1,000 |
| Last Week |
19,000 |
0 |
* Price does not include taxes. 12.36% taxes will be included in final amount.
* 10% discount on group of 5 or more. |
Cancellation Policy
Requests for cancellations or date transfers need to be received at least Seven (7) business days prior to the event in order to receive a 25% refund. If a cancellation or reschedule request is received less than Seven (7) business days before the start date, the penalty of 100% of the cost will be applied. Refunds will not be allowed for "no-shows". If your plans should change, you may designate a substitute to attend in your place at any time. This cancellation policy is strictly enforced.
Cancellation Liability
ComplianceOnline reserves the right to cancel events for any reason at anytime. Cancellation liability is limited to the return of payment ONLY. ComplianceOnline will not reimburse registrants for any travel cancellation fees or penalties, including airfare and hotel. |
